Title: Clinical Research Associate
Duration: 6 Months
Location: Lexington, MA
Hours: 40 hours per week
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Summary: The in-house Clinical Research Associate (CRA) is responsible for providing support for day-to-day clinical study activities under general supervision of the Clinical Project Managers. The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. The CRA performs work within established protocols under general supervision.
Day to Day Duties/Responsibilities/ Scope of Work
- Oversee conduct of assigned clinical studies in support of the Clinical Project Manager.
- Maintain site files, trial master files and study documentation.
- Provide oversight of Clinical CRO regarding assigned tasks (such as: Investigator background checks, ICF generation)
- Develop status reports, SOP revisions and document quality control.
- Review and process regulatory documentation, ensure the execution of clinical trials in a timely, efficient manner, working within established timelines and budgets.
- Experience working in clinical research as an In-house Clinical Research Associate, Clinical Research Coordinator, or Regulatory Affairs position.
- Assists the study team to deliver the clinical study within agreed timelines.
- Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
- Bachelor's degree required
- 1-3 years' experience in similar/relevant field (Sponsor, CRO, Clinical trial Vendor, Clinical Coordinator, etc.)
- 0-2 yrs. of experience managing multiple studies at various locations - regionally or nationally
Sthree US is acting as an Employment Business in relation to this vacancy.