Job Posting Currently seeking a CRA Assistant in Nashville for our Early Clinical Development group.
Provide in-house clinical monitoring support for CRAs according to Covance Standard Operating Procedures, ICH and GCP Guidelines. Develop and/or maintain tracking systems for clinical monitoring projects.
A. Duties and Responsibilities:
- Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
- Tracks progress of monitoring projects and identifies appropriate actions to achieve target objectives.
- Develops and maintains CRA Monitoring Trip Calendar for all ECD monitors.
- Tracks completion of monitoring trip reports compared to monitoring plans and contracts. Notifies Supervisor of deviations.
- Acts as an in-house contact and resource for monitors when they are traveling.
- Assist CRAs with other administrative activities as required (e.g., correspondence with clients, preparation of status reports, and completion of Project Updates) for Monitoring Only studies.
- Assist with the implementation of Project Plans related to the Clinical Monitoring responsibilities for Monitoring Only studies.
- May assist in the generation of study specific monitoring plans
- Serves as a backup contact for the clinical sites/Sponsor for Monitoring Only studies
- Conduct a final review of the Monitoring Only File and archive files as appropriate
- May assist with the coordination of monitoring visits.
- Ships and tracks monitoring letters for monitoring visits.
- Create, update, track and maintain study-specific trial management files, tools and systems for Monitoring Only studies.
- Tracks Project Updates for timely completion and notifies Supervisor of deviations.
- Formats CRA meeting agenda and meeting minutes for all CRA meetings and distributes minutes to the team.
- Format new processes, forms and templates for the CRA team as needed.
- May assist with full scope projects as needed.
- Performs other related duties as assigned. Education/Qualifications • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- Knowledge of science or a scientific background is preferred.
- Advanced knowledge of computers and programs (e.g., word processing, excel, power point)
- Ability to work in a fast-paced setting with many interruptions.
- Requires great attention to detail. Experience Required: USA
- 1 year of relevant clinical research experience in a pharmaceutical or CRO industry position.
- Additional experience may be substituted for education requirements.
- Typically 1 year of relevant clinical research experience in a pharmaceutical or CRO industry position.
- Additional experience may be substituted for education requirements. EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance - 19 months ago
Covance Inc. is a drug development services company providing a range of early-stage and late-stage product development services on a...