Centralized Visit Report Reviewer II

Job Summary:

• The Centralized Visit Report Reviewer II serves as a member of a project team reviewing and approving site monitoring visit reports. Leveraging their experience, the SCVRR works with some oversight, managing report review and issue escalation for a range of studies and/or portfolios of work.

Essential Job Functions:

• Performs review of clinical monitoring visit reports for allocated projects ensuring consistency as per annotated report, across protocols and SOPs. Escalates protocol, site, and/or CRA issues or trends noted during the report review process to CTM. Offers insights and solutions.
• Liaises with clinical monitoring staff for prompt monitoring visit report review submission and approval as per the Precision/Sponsor SOP timelines. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
• Evaluates Investigator and Site performance and/or ability to adhere to study and protocol requirements as ascertained from information in monitoring visit reports and associated electronic data systems. Escalates areas of concern to study leadership. Provide information and evidence to support concerns.
• Oversees use of CTMS (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary.
• Ensures open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards
• Attends internal project meetings and actively provides suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends
• Collaborates with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
• Ensures all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner
• Provides insights and recommendations towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics.
• Actively supports staff with change management.
• Supports the development of reporting, tools, and processes to that can be used by the CVRR team to identify and address study performance concerns early.  Identified methods for performing work that can be improved through process change and/or better documentation.
• Supports to company, client, and federal/local regulatory requirements/audit responses as needed
• Performs other duties as assigned by management

Qualifications:

• Bachelor’s Degree in a life science-related field (nursing, medical, physiology, pharmacy, etc.) or relevant/equivalent combination of education, training, and experience
• Minimum 3 years experience in clinical monitoring, clinical trial management  or equivalent
• Working knowledge of ICH GCP guidelines and the clinical development process

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Ability to work in a team or independently as required
• Prior experience reviewing and/or approving clinical monitoring visit reports
• Proven ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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