Freelance CRA - UK in London

IQVIA has several exciting positions in the UK for freelance CRAs.

Location: United Kingdom, travel needed across the UK for site visits

Hours: TBC

Contract: Freelance

Start: asap

Duration: Approx. 6 months

Basic Functions:

• Participates in the preparation and execution of Phase I-IV clinical trials.
• Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.
• Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
• Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

Responsibilities:

• Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
• Coordinates activities with the site and internal departments in preparation for the initiation of the study.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
• Performs validation of source documentation as required by sponsor.
• Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor.
• Performs investigational product inventory.
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
• Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures all study deliverables are completed per IQVIA Biotech and study timelines.
• Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

Knowledge, Skills and Abilities:

• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
• Minimum of 2 years experience as a CRA.
• Experience in monitoring and/or coordinating clinical trials required.
• Oncology experience needed.
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Able to handle several priorities within multiple, complex trials.
• Able to reason independently and recommend specific solutions in clinical settings.
• Able to work independently, prioritize, and work within a matrix team environment.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

If this role sounds of interest, please apply today!