Senior Clinical Research Associate (SCRA)
The SCRA will support clinical trial management with the implementation and conduct of clinical trials.
- Drive start-up activities at U.S. study sites
- Provide site management and monitoring for assigned clinical trial(s) and ensure protocol requirements, regulatory guidelines, and study timelines are met
- Support the management of monitoring activities at clinical trial sites to assure adherence to Good Clinical Practices (GCPs) and study protocols
- Provides guidance with the development of the trial’s protocol, Informed Consent Form, CRFs, monitoring plan, site reference materials, and other study related materials
- Conduct pre-study, study initiation, interim monitoring, and close out visits and completes associated monitoring visit reports and follow up letters to investigators
- Assist with inspection-readiness activities for regulatory agencies.
- Assist in the planning of and participates in investigator meetings.
- May assist with the development and negotiation of site budgets
- Travel required
- Minimum BS / BA (science or health care field) or nursing degree
- 6 or more years’ experience as a CRA or field monitor at in a pharma or CRO setting
Preferred Skills, Qualifications, or Technical Proficiencies:
- Attention to detail and ability to prioritize tasks to meet critical deadlines
- Excellent verbal and written communication skills
- Able to collaborate effectively with the study team, cross-functional team members, and external partners
- Knowledge of ICH/GCP and FDA regulations
- Strong proficiency in Microsoft Office
If you are interested, please submit your resume by email to firstname.lastname@example.org