The Clinical Trial Specialist will assist the Clinical Research Team with the development and implementation of clinical research projects.
Key Responsibilities
- Assists clinical management with the development and distribution of study-related documents including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees.
- Coordinates communication with CRAs and other ICs assigned to project team
- Ensure requisite training completed
- Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQs.
- Gathers documents and information for clinical investigator and laboratory selection.
- Collects and tracks regulatory documentation to ensure compliance at both the sites and Sponsor Central File.
- Assists PM in coordinating document review with sites
- Clinical Trial Agreements
- Informed Consent forms
- IRB approval
- Submits regulatory documentation and correspondence to the designated personnel for filing in the Clinical Trial Master File (CTMF).
Requirements for the position include:
- Bachelor’s degree. Degree in science/health-related field (e.g., biology, nursing, biomedical, etc.) preferred.
- Three to five (3-5) years of experience in clinical/scientific research or clinical trials administrative execution.
- Strong computer skills and ability to learn and become proficient with appropriate software.
- Superior organizational skills and attention to detail.
- Strong written and oral communication skills required.
Candidates must also pass a drug and background screen. Beaufort offers a competitive salary and benefits, including but not limited to medical and dental coverage and paid time off.
E-mail your resume with subject line Clinical Trials Specialist to jobs@www.beaufortcro.com. Beaufort, LLC, is an Equal Opportunity Employer.
