Senior Clinical Research Associate
About the role
Senior Clinical Research Associate
ClinChoice is a global, full-service CRO providing clinical research services to pharmaceutical, biotechnology, medical device and consumer health companies. We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join our in-house team.
As a Senior CRA, you will manage 2–3 clinical trials and be responsible for site management activities, including study start-up, site monitoring, and closeout. You'll conduct both on-site and remote monitoring while supporting a variety of studies across a diverse client portfolio, from emerging biotech companies to large pharmaceutical organizations.
This is a permanent, fully remote position. Candidates must be willing and able to travel to investigative sites as needed. This role is remote, ideal locations are West Coast, Northeast and/or Florida.
Main Job Tasks and Responsibilities
- Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
- Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites.
- May act as Feasibility Associate.
- Train site staff in all study procedures.
- Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
- Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
Qualifications: Candidates must have experience monitoring oncology and other complex clinical trials, as well as previous experience working for a CRO. A strong understanding of GCP, ICH guidelines, and clinical trial operations is also required.