Note: The job is a remote job and is open to candidates in USA. Kelly Science & Clinical is seeking a Senior Clinical Research Associate for a full-time, long-term contract position with a biotech company in California. The role involves executing clinical trials, supporting study site identification, monitoring plans, and ensuring compliance with GCP and protocol requirements.
Responsibilities
- Execute all activities related to a clinical study, including (but not limited to):
- Clinical site selection
- Site contract and budget negotiation
- Study initiation visits
- Interim monitoring visits
- Study close out visits
- Data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness
- Identify and suggest ways to resolve problems or issues at site associated with GCP or protocol compliance which could affect the integrity of the data or timely completion of the clinical study
- Prepare study documents for review by project lead. Documents may include but are not limited to:
- Training materials
- Case Report Forms
- Study procedure guidance document
- Protocol specific ICF
- Maintain a high level of familiarity with GCP and assigned protocols
Skills
- Bachelor's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry and/or Human Physiology, or similar)
- Minimum of 5 to 8 years of experience with monitoring In Vitro Diagnostic (IVD) products
- Experience in all aspects of a clinical trial including, but not limited to, clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.)
- Remain current on clinical trial regulatory requirements and guidelines (e.g. GCP, ICH, FDA, etc) with the ability to translate current regulatory requirements into clinical trial
- Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff
- Ability to travel 30-60% (mostly for study startup and closeout)
- Must have IVD monitoring experience clearly documented on resume or your application will be rejected
- Experience with in vitro diagnostic (IVD) products in molecular diagnostics or immunodiagnostics especially in the areas of oncology and/or infectious disease
- Experience with laboratory automation and biological databases
- CCRA certification
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