Clinical Research Associate Job
Job Code - 9132
Position - Full - Time Regular
Job First Active on: Wednesday, April 11, 2012
Clinical Research Associate
The Clinical Research Associate is primarily responsible for monitoring in-house clinical studies. This position requires approximately 50% travel and includes the following responsibilities:
• Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconciles clinical supplies and drug accountability records at study sites.
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
• Tracks study specific tasks and progress of the trial.
• Performs regulatory document review and approval for IP release.
• Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
• Conducts monitor training.
• Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Understands and implements processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitors compliance of these processes.
• Collaborates with data management to resolve queries.
• Facilitates investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
• Assists in evaluation of vendor performance during conduct of the study.
• Acquires a basic knowledge of the therapeutic area and product.
• Obtains a complete understanding of all trial-related documents and operational procedures.
• Gains exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.
• Maintains clinical trial management system (CTMS) information pertaining to the study.
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Prepares accurate and complete meeting minutes for various meetings.
• Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Associate
Position requries a minimum of an Associate’s degree in a life science field. Bachelor’s degree in a life science field preferred.
Requires a minimum of 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead Clinical Research Associate role.
Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, CTMS (Impact), and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel.
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