CRA I PROFICIENCIES

Operating Systems

• Understand on a basic level and use common, necessary operating systems to complete daily tasks (e.g., email, spreadsheets, presentations).

Technical Issues Management

• Determine IT issues and escalate to resolution through appropriate channels.
• Adjust to connectivity:
  • be aware of the wireless strength signal.
  • know about Wi-Fi signal issues (areas that are spotty).
  • know how to connect the laptop to a Wi-Fi source

Clinical Systems

• When joining a study team, ensure knowledge of all systems (including PPD and/or other vendors) in use, including but not limited to IXRS, EDC, eTMF, CTMS, etc.

Adoption and Application

• Demonstrate a willingness to learn and adapt to new systems and technology.

Remote CRA

• Raise queries, review data currency, track monitoring activities, and report on progress of completion with some support.

Onsite CRA

CRA I PROFICIENCIES

Compliance with Electronic Record Requirements and Regulations

• Confirm that site systems used for study conduct are assessed for study use and compliant with ICH GCP.  Verify that system access is well controlled.  Escalate issues with compliance to study management.
• Demonstrate understanding of personal privacy issues related to the collection and use of data.

Use of PPD Provided Technology

• Follow all PPD policies involving the use of company-provided technology and systems for personal use, including but not limited to any SOPs regarding use of technology, the Global Privacy Policy and telecommunications policy.
• Act in a manner that appropriately represents PPD when using PPD technologies.

Systems Access

• Confirm that site staff have appropriate access to the necessary study systems based on PI-assigned delegated duties.
• Understand the  importance of limited access.
• Request access revocation when participation in a study is finished (i.e., staff changes).

Remote CRA

• Identify and escalate issues with compliance at their sites to study management with some support.
• Ensure availability of reports to the monitoring team.

Onsite CRA

• Identify and escalate issues with compliance at their sites identified during on-site visits to the Remote CRA with support as needed.

CRA I PROFICIENCIES

Data Flow

Demonstrate knowledge of:

• the flow of different types of data throughout a clinical trial (EDC, tracking systems, etc.).
• data stakeholders.
• how/what role Data Management and Biostatistics serve in the lifecycle of a study.
• the process of data capture and the importance of technology in data collection, capture, and management.

Data Stewardship

• Understand the significance and importance of data quality assurance and how SOPs are used to guide those procedures.
• Demonstrate understanding of the importance data entry into appropriate systems in real time.
• Understand the importance of following tracking guidelines to ensure data consistency/stewardship.

Data Accountability and Ownership

• Take responsibility for data review and stewardship, asking  questions to ensure the responsibilities have been well understood and the timelines agreed upon.
• Identify data problems/risks at a site level.
• Escalate to People Manager or CTM any struggle to comply with expected data timelines .
• Discuss potential solutions to be implemented when data timelines/expectations cannot be met.
• Be open to changes, including, but not limited to new methods of working, procedures, and technologies when dealing with data.

Data Gathering

• Demonstrate ability to identify relevant sources of data needed for personal metrics review and site risk review.
• Perform basic data querying across study systems and platforms.

Remote CRA

• Communicate in an appropriate and timely manner with data management and centralized monitoring team members as needed with some support.
• Communicate in an appropriate and timely manner with vendors and others as applicable at study level with some support.
• Actively review data for stewardship completion across all sites and coordinate with local project team members as needed with some support.
• Coordinate with peers/managers on the root cause analysis and implement solutions, including corrective and preventative actions regarding data stewardship and quality risks with data review with some support.
• Organize data to review with data cleaning to avoid data errors such as handling missing and/or data inconsistencies with some support.

Onsite CRA

• Closely communicate in an appropriate and timely manner with Remote CRA.

CRA I PROFICIENCIES

Critical Data & Processes

• Perform data review using system of record to identify and mitigate potential issues and risks.
• With support, begin to develop an awareness of the interrelatedness of study systems and analyze data trends to direct future monitoring actions.
• Communicate with centralized monitoring team members.
• Perform data review using system of record to identify and mitigate potential issues and risks.
• Reference risk assessment documentation to anticipate and mitigate potential issues.

Data Analysis and Interpretation

• Determine where to retrieve data from the appropriate systems in order to best review for risk.
• Use available systems, dashboards, data and information that is provided for projects to identify inconsistencies.
• Implement common retrieval and filtering applications within data systems.
• Take advantage of available systems to manipulate/analyze, investigate, evaluate data to get more complex results.

Personal Performance Metrics

• Demonstrate ability to review personal performance  with metrics and systems technology.
• Assess for outliers.
• Review with management during 1:1 and discuss plan of action to improve, as needed.
• Proactively ask people manager feedback on technology and systems understanding to  clearly understand personal strengths and weaknesses.
• Be conscious of areas for further development in systems and technology and  work with the people manager to improve.
• Build skills in technical systems and data areas to address learning deficiencies/needs.
• Observe industry trends in technology and data review.  Become familiar with available sources of training/information.

Site Performance Metrics

• Demonstrate knowledge of specific data metrics that relate to site performance.
• Assess outliers for potential risk.
• Review with Study Management to determine plan of action in addressing risk outliers with the site.

Remote CRA

• Analyze data to generate an on-site visit work order with some support.
• Continuously assess data from multiple sources including centralized monitoring to understand how the site is performing with some support, identify signals to prevent performance deterioration or identify emerging risks with some support.

Critical Data & Processes

• Decisions regarding when an on-site visits is needed.
• Generation of an on-site visit work order with some support.

Onsite CRA

CRA I PROFICIENCIES

PI Oversight

• Monitor sites for PI oversight, protocol and study guidelines adherence.
• Evaluate the PI’s availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP; and overall level of involvement in implementing compliance.
• Escalate to the CTM detailed information if lack of proper oversight is identified.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.

Roles and Responsibilities

• Assess PI qualification and resources.
• Verify documentation of investigator oversight and delegation.
• Throughout the trial, evaluate investigator and site staff for qualification and training, provide study-specific training and inspect facilities to confirm adequacy.
• Evaluate in detail compliance with the protocol and GCP and investigator engagement and revise, with guidance, risk mitigation plans as necessary based on performance.
• Confirm the PI or delegated staff member has performed and documented all activities.
• Regularly discuss site staff workload to detect impact on the project and/or data quality.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.

Regulatory Adherence

• Identify deviations from the protocol, SOPs, regulatory requirements during site discussions and document/source review.
• Discuss all protocol and regulatory misconduct with the site staff and PI.  •Determine resolution to ensure further deviation does not occur.
• With the support from other team member (CTM, SCRA), work on a corrective and proative action plan in order to avoid recurrence.
• Provide training/retraining, if applicable. Document it accordingly.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.
• In case of recurrent deviations, discuss with CTM and LM option for sPIP.

Remote CRA

• Coordinate and oversee all aspects of the clinical-monitoring, remote-monitoring, and site-management processes with support.
• Gather information from the on- site CRA and escalate detailed information to the CTM if improper oversight is identified with support.
• With the support of other team members (CTM or experenced monitor), work on a corrective and proactive action plan in order to prevent recurrence.

Onsite CRA

• Escalate detailed information to the Remote CRA if improper oversight is identified.
• Throughout the trial during each on-site visit, evaluate the Investigator and site staff for qualification and training, provide study-specific training, and inspect facilities to confirm adequacy.
• Work with the Remote CRA on a corrective and proactive action plan to prevent recurrence.
• In the event of recurrent deviations, discuss option for sPIP with the Remote CRA and the People Manager.

CRA I PROFICIENCIES

Subject Recruitment and Retention

• Engages in discussions about recruitment/retention of study subjects , evaluates recruitment/retention strategy of the site, discusses potential recruitment/retention challenges and escalates risks issues associated with recruitment to the CTM.
• All activities closely supervised by People Manager and the CTM or an experienced monitor.

Conduct of Monitoring Visits

• Receives authorization to conduct remote and onsite visits independently.
• Gets well prepared to conduct remote/onsite visits.
• Assesses study protocol activities to verify trial records are accurate, complete and current.
• Evaluates compliance with the protocol, IP guidelines, GCP and investigator engagement and revises, with guidance, risk mitigation plans as necessary based on performance.
• Assess site processes and identify potential risks, applying concepts of effective training methods to manage those potential risks processes proposing actions to the site be back on track.
• All activities closely supervised by People Manager and the CTM or an experienced monitor.

Risks, issues and trends identification

• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable. Discuss actions with CTM and LM.
• Have all  activities closely supervised by People Manager and the CTM or an experienced monitor.

Remote CRA

• Coordinate local input into the site list development with support from a People Manager or an experienced monitor.
• Ensure all system access and study training for site staff is current utilizing study reports and dashboards.
• Review and provide TA input into patient-facing materials and Country Master ICFs with support.
• Ensure site readiness to begin enrollment; at the direction of the project team, trigger site activation with support.
• Gain authorization to conduct remote monitoring independently under close supervision by the People Manager and CTM or by an experienced monitor on larger projects.

Onsite CRA

• Provide the Remote CRA with input for the potential site list.
• Ensure the Remote CRA and project team are aware of all issues impacting site activation or recruitment and share plans for resolution.
• Use critical thinking to identify or review the site-specific patient pathway for protocol, opportunities to enhance the pool of potential subjects or tools to retain subjects; discuss actions with the Remote CRA and the LM.
• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable; discuss actions with the Remote CRA and the LM.
• Receive authorization to conduct on-site visits independently.

CRA I PROFICIENCIES

Site Communication

• Provide clear and effective, technically accurate information and instructions both verbally and in writing.
• Maintain effective and timely communication with the site staff.
• Demonstrate active listening skills.
• Follow all communication pathways per study team requirements and ensure that it is properly documented.
• Identify and escalate privacy and confidentiality violations and implement corrective actions. Comply with global and local laws and PPD processes.
• Identify and escalate issues and implement corrective action.
• Document site communications appropriately.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.

Persuasion / negotiation with the site staff focusing on study deliverables

• Use critical thinking to suggest effective corrective and preventive actions to the site.
• Have all activities closely supervised by People Manager and the CTM or an experienced monitor.

Remote CRA

• Act as the primary contact with the site relevant to clinical-monitoring tasks, effectively coordinating reach-outs to sites via video or teleconference, phone, and emails across the monitoring team with support.
• Work closely with the monitoring team to maintain frequent site-managment contact.
• Identify when the start-up team may benefit from support to resolve issues and remove barriers.
• Use critical thinking to identify the root cause of problems and coordinate a robust CAPA plan across the monitoring team, if applicable; discuss actions with the CTM and the LM.

Onsite CRA

• Use critical thinking to identify the root cause of problems and a robust CAPA plan, if applicable; discuss actions with the Remote CRA, the CTM, and the LM.
• Identify when communication should flow through the Remote CRA as the main contact with the site.

CRA I PROFICIENCIES

Industry Foundation

• Have fundamental knowledge of the Product Development Lifecycle and Significance of Design Features in Clinical trial protocols.
• Possess basic knowledge of how drugs, devices, and biologics are developed and regulated.
• Know all local compliance regulations /adhere to legal, ethical framework/guidelines.
• Know working country regulations, ICH GCP and requirements.

Research Design

• Understandi PPD business model and core values.
• Know protocol design: structure, critical sections, critical information and identify potential clinical risk based on protocol design and disease indication.
• Understand the reporting requirements for global regulatory bodies relating to clinical trial conduct.
• Recognize importance of primary/secondary endpoints and their application to monitoring.

Roles and Responsibilities

• Understand the roles of the monitor and  site  sponsor, as well as  the regulatory framework and ethics pertaining to ICH GCP.

Remote CRA

• Continually verify adequacy of site staff qualification; site documentation, including policies & procedures and potential patient population for the protocol; and make a determination on site suitability for the trial.
• Escalate quality risk to the CTM regarding site staff when inadequacies/deficiencies are identified at the site; document in work order any quality risks for on-site CRA awareness to review during a triggered on-site visit with support.
• Ensure all activities are closely supervised by the People Manager and the CTM, or by an experienced Monitor on larger studies.

Onsite CRA

• Verify adequacy of site staff qualification; examine site facilities, site documentation (policies & procedures), and potential patient population for the protocol; and make a determination on site suitability for the trial during on-site visits with some support from a People Manager or a CTM, or by an experienced Monitor on larger studies.
• Verify that facilities remain adequate to perform the trial and compliant with ICH-GCP and applicable regulatory framework, with some support from a People Manager or a CTM, or by an experienced Monitor on larger studies as needed.
• Escalate quality risk to the Remote CRA and CTM regarding site staff when inadequacies/deficiencies are identified at the site, with some support from a People Manager; or escalate quality risk to an experienced Monitor on larger studies as needed.

CRA I PROFICIENCIES

Therapeutic Area (TA) Knowledge

• Maintain general knowledge of different diseases/disorders, biologic & pharmaceutical agents.
• Understand the basics of the therapeutic area in order to monitor and ensure subject safety/data integrity.
• Possess a sound foundation of medical terminology.
• Explain the study-assigned disease condition, identify signs/symptoms and documentation of diagnosis in source.
• Describe the indication and standard of care.

Work Prioritization and Scheduling

• Take responsibility for own visit planning and ask  questions to ensure all required tasks have been well understood and the timelines agreed upon.  Proactively ask for support from the CTM and/or PeM on  how to prioritize and schedule.
• Evaluate assignments, prioritize and manage work activities according to study plans.
• Plan visit activities and share with stakeholders so that an assessment of activity levels can be monitored.
• Escalate visit activity risks to ensure internal team mitigate effectively to achieve on-time deliverables.

Plans and Conducts Monitoring Visits. 

• Know and adhere to monitoring plans, standard operating procedures, and other written procedures in reference to conducting monitoring visit (PSVs. SIVs, IMVs, COVs).
• Demonstrate potential to be mentored and to manage complex issues with study visit scheduling and planning, including appropriate visit forecasting.
• Manage issues with the planning and conduction of monitoring visits with support and escalate potential risks to visit deliverables to appropriate team/manager.
• Ensure proper time is planned for monitoring visits to be certain all activities are completed as required.
• Show flexibility when working with site staff for scheduling of visits and completion/timing of activities while onsite.
• Persevere  through all required elements of a site visit in spite of opposition or difficulty.

Safety Oversight

• Know protocol-specific requirements regarding safety and adverse events.
• Identify subject safety risks and issues in source documents.
• Understand safety reporting process for PPD/client, in addition to the regulatory agencies for both pre- and post-approval.
• Be aware of the methods by which safety issues are identified onsite and managed.
• Differentiate the types of adverse events that occur during clinical trials and understand the identification/reporting process related to regulatory authorities, sponsors and IRBs/IECs.

Remote CRA

• Share concerns for timely completion of monitoring tasks and request additional resources from internal team to achieve on-time deliverables.
• Explain the study-assigned disease condition to the startup team and on-site monitoring team based on their level of experience.
• Describe therapeutic indication and standard of care to the start-up and on-site monitoring team based on their level of experience.
• Effectively coordinate the activitites of monitoring team with some PeM, CTM, or experienced monitor support.
• Take responsibility for generating the on-site CRA work order (WO); ensure tasks required to be completed by the on-site CRA are outlined in the WO and are well understood and that the timelines are agreed upon by the on-site CRA.
• Proactively ask for support from the CTM and/or PeM regarding how to generate the WO.
• Prepare the SIA work order including FU actions related to Systems & Supplies, Essential Documents (including SRAP), and other pending site issues; and determine the method for SIA (Site Initiation Assessment) in consulation with the STM/CTM.
• Manage issues related to the planning and conduction of Site Management Contacts and ongoing remote site-monitoring activities; generate the WO with support; and escalate potential risks to visit deliverables to the appropriate team/manager.
• Demonstrate the potential to be mentored and to manage complex issues related generating on-site CRA work orders (WOs), including assessing whether there is enough work to support an on-site IMV.
• Ensure all activities are closely supervised by the People Manager and the CTM, or by an experienced Monitor on larger studies.

Onsite CRA

• Take responsibility for visit planning once requested by Remote CRA and ask questions to ensure all required tasks outlined in the on-site CRA work order (WO) have been well understood and the timelines agreed upon.
• Manage issues related to the planning and conduct of monitoring visits with support, and escalate potential risks to visit deliverables to the Remote CRA or Manager.

CRA I PROFICIENCIES

Training

• Complete and record role-specific and project-related training within defined timelines in the PPD Learning Management System.
• Submit and update CVs as per policy.
• Understand and follow the  PAV process.
• Understand clinical research environment and PPD business, mission, vision, and defining principles.

Audits and Inspections

• Follow PPD/sponsor procedures for hosting/supporting client audits, routine clinical investigator site audits, process audits, managing GxP regulatory inspections, and  other procedures for specific audit types with support.
• Provide support on site, if  client agrees, or remotely.
• Distribute the summary report per  the distribution list.
• Communicate with site personnel, PPD QA, and project leadership.
• Assist the site and project team in the development of audit / inspection response in a collaborative manner.

Site Compliance & Communication including sPIP

• Develop collaborative relationships with investigational sites by appropriate methods to communicate effectively.
• With support, assess site capabilities and develop plans to support the site to achieve compliance, e.g., via training, ongoing communication and procurement of relevant study tools.
• Identify deviations from the protocol, SOPs, and the applicable regulatory requirements, and document non-compliance as per project guidance.
• Escalate issues and confirm ethics committee reporting as required.
• With support, discuss and come to agreement with the site on corrective and preventive actions by listening closely.
• Follow up in a timely manner to verify compliance and perform effectiveness checks where required.
• Protect study blind, if applicable.
• Ensure audit readiness with accountability.
• Retrain site personnel as needed with support.

Essential Documents and eTMF 

• Understand required Essential Documents according to ICH-GCP Section 8 along with local regulations.
• Provide quality checks of ISF content in line with  Good Document practices and applicable global guidance and regulations for currency with guidance and attention to detail.
• Follow eTMF process. Perform QC to verify the document meets applicable standards as per guidance.
• Verify that the investigator is aware of ISF maintenance and archiving responsibilities and has plans to comply with requirements.

ICH-GCP, PPD/Sponsor SOPs, Local Regulations & Requirements,
Site SOPs and ISF, Good Documentation Practice, ALCOA principles

• Understand and review ICH-GCP, PPD and/or sponsor SOPs, WPDs, local regulations & requirements, site SOPs, ISF, Good Documentation Practice and ALCOA principles.
• Holistically assess compliance with applicable processes & requirements throughout the trial with support when needed.
• Identify and escalate non-compliance and implement corrective and preventative actions with support.

Monitoring Plan

• Understand and comply with monitoring plan requirements with support.
• Collaborate with study team to address potential areas of concern.

Electronic Record Requirements 

• Understand, maintain, and comply with PPD/sponsor SOPs and mitigate risk with site as it relates to EMR/EHR with support.
• Comply with and regularly verify site and local regulatory EMR requirements and/or SOPs.

Remote CRA

• Act as the main contact point for issue resolution and coordinate efforts across the monitoring team with some support.
• If the client agrees, provide support remotely to the on-site CRA.
• Remain aware of all data reports and tools available to support CRA monitoring activities and ask for mentoring as needed to ensure knowledge and understanding of all available reports, dashboards, and tools supporting data review.
• Act as the main contact with the site to assess site capabilities and develop plans to support the site to achieve compliance, e.g., training, ongoing communication and procurement of relevant study tools with some support.
• Assimilate all instances of non-compliance identified across the monitoring team and implement holistic corrective and preventative actions with support.
• Lead a discussion and come to an agreement with the site on corrective and preventative actions with support.
• Be the primary collaborator with the site to ensure adequate implementation of corrective and preventative actions, with some support.

Onsite CRA

• Ensure the site is aware of the role of the Remote CRA as the main contact point for issue resolution.
• Maintain effective communications with the Remote CRA.
• Provide support on site if the client agrees with some support from the Remote CRA, the CTM, and the People Manager.
• Supported by and the direction of the Remote CRA , assess site capabilities and develop plans to support the site to achieve compliance, e.g., training, ongoing communication, and procurement of relevant study tools.
• Communicate with site personnel, PPD QA, Remote CRA, and project leadership with some support from the People Manager.
• With support from the Remote CRA, discuss and come to agreement with the site on corrective and preventive actions by listening closely; and ensure that site personnel are aware that the Remote CRA is main contact point.

CRA I PROFICIENCIES

Effective Risk Management 

• Identify potential risks; assess, manage, and escalate when necessary with support.
• Understand and utilize escalation pathways when appropriate. Implement mitigation plans with support.
• Complete KRI review and evaluate Site Health Assessment prior to each monitoring visit.
• Communication with CTM to initiate quality-related queries via AskCQA.

RCA & CAPA and Documentation 

• Understand and implement RCA and CAPA process and implement action plan and effectiveness checks with support.
• Consult people manager or CTM when needed prior to taking decisions.
• Regularly monitor for sustained performance and/or continual improvement.
• Verify documentation of the process and follow up when necessary.

Remote CRA

• Act as main escalation point across the monitoring team and drive issues to resolution with some support.
• Perform KRI and site health asessement during the remote review period and prior to site-management calls with some support.
• Trigger an on-site visit work order, as needed, based on continous KRI review with some support.
• Oversee the implementation of the action plan and effectiveness checks with some support.

Onsite CRA

• Maintain escalation pathways with the Remote CRA.
• Ensure remote CRA is consulted prior to making decisions.
• Complete the on-site work order and KRI review and evaluate site health assessment prior to each monitoring visit.

CRA I PROFICIENCIES

Subject Confidentiality, Data Protection and Privacy

• Identify confidential information and comply with PPD SOPs and all applicable laws and guidelines.
• Detect cases after review of the documents and take immediate actions for remediation with guidance.
• Complete documentation and retrain the site.
• Identify and report the breach as per procedures.

Informed Consent Process

• Determine if the subject was consented appropriately prior to subject participation and verify informed-consent documentation per relevant guidelines and regulations.
• Verify evidence that the subject was kept informed during the study.
• Identify, escalate, and document informed-consent deviations and follow-up for resolution with support.

Scientific Misconduct

• Identify signs of misconduct.
• Immediately report suspicions of misconduct through management and appropriate reporting pathways.
• Assist as needed with the collection and submission of additional information with respect to misconduct.
• Maintain strict confidentiality of all information except for the reporting requirement.
• Consult with line management, project management or GQC on the immediate actions to take.
• Carefully document specific evidence of any suspicion of scientific misconduct.
• Cooperate with any third-party investigation of suspected scientific misconduct and questionable data practice.
• Seek guidance on how to facilitate corrective and preventative action plan.
• Tactfully discuss concerns with the principal investigator, listen before taking any actions, and implement action plan with support from stakeholders.

Remote CRA

• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and lead the implement action plan with some support from stakeholders.

Onsite CRA

• Tactfully discuss concerns with the Principal Investigator, listen before taking any actions, and implement action plan as agreed with the Remote CRA and stakeholders.