Job Description
Job Title: Clinical Research Associate I
Location: Durham, NC
Hours/Schedule:8 hours per day, 40 hours per week - Flexible day shift - 3 days on site weekly
Type: Contract Job Description The manager would be looking for this person to work in the office 3 days a week. This is considered a level 1 position (slightly above entry) as they will need to have experience with onsite monitoring.
JOB DESCRIPTION: - 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, with supervision.
- Assists in providing with effective and timely audit/inspection responses
- Carries out in house clinical monitoring activities
- Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up
- Conducts monitor training Assist in the clinical trial management
- Tracks study specific tasks and progress of the trial
- 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
Carries out in house clinical monitoring activities
- 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 clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study
- Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study
- 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
Conducts monitor training Assist in the clinical trial management
- Tracks study specific tasks and progress of the trial
- 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
- Performs regulatory document review and approval for IP release
- Monitors processes for distribution and tracking of SAE’s, safety documentation, and pregnancies
- 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 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.
Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Job Tags
Contract work, Interim role, Flexible hours, 3 days per week,