- 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.
- Coordinate 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 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 CRO 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 study timelines
- Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
- Serves as mentor for junior CRAs and those new to the company and/or study.
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
- Experience in monitoring and/or coordinating clinical trials required.
- 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.