Job Description
The Senior Clinical Research Associate (Sr. CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH E6 Good Clinical Practices, FDA guidelines, local regulations and standard operating procedures.
Responsible for performing the clinical monitoring aspect of designated projects in accordance with applicable SOPs; performing clinical on-site monitoring activities (e.g. monitor patient recruitment, review consent forms for each patient, source data verification, drug accountability, data collection), collecting regulatory documentation, performing qualification, initiation, monitoring and termination visits of investigational sites, writing visit reports and completing all follow up actions in accordance with ICH GCP guidelines.
This position is remote with travel within the West Coast. Will keep candidates as regional as possible.
Position Type: Contract (W2 ONLY) and Salaried roles!
- Desired Knowledge and Abilities:
- Proven clinical monitoring skills.
- Demonstrated understanding of medical terminology.
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures.
- Flexibility; ability to travel up to 70%
- Remote flexibility
- REQUIREMENTS: (APPLICANTS WILL NOT BE CONSIDERED WITHOUT THESE REQUIREMENTS)
- BA/BS or RN degree required.
- MINIMUM 3 YEARS OF CRA EXPERIENCE WITH EITHER A SPONSOR COMPANY OR CRO! No academic or hospital/research organizations.
- Oncology experience required within the past two years!
- Candidate must be located in the West Coast
Apply tot his job
Apply To this Job