BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific and Clinical Research community. We currently have a contract opening for a Clinical Research Associate II for a Biopharmaceutical Sponsor in San Diego.
Clinical Research Associate II
SAN DIEGO CANDIDATES ONLY!
The Clinical Research Associate II will manage the conduct and monitor designated clinical trials and other related projects throughout the US and international locations in accordance with ICH guidelines, FDA Regulations and Company SOPs.
As a member of the clinical project team, provides CRA oversight for the managed clinical trials. This includes but is not limited to planning, organizing, and communicating with and managing sites to allow them to meet study objectives for study protocols.
Participates in clinical team meetings; assists discussion on assigned protocol(s).
Prepares a variety of documents including protocols, CRFs, informed consent forms, operations manuals, and other documentation required for the conduct of a clinical trial.
Identifies potential investigators. Conducts and/or reviews pre-study site visits to assure adequacy of site, investigators, and research staff in accordance with SOPs and relevant regulations/guidelines. Recommends acceptable sites to study and management teams.
Manages day-to-day clinical operations of assigned protocol(s), including management of vendors (e.g., CRO, central lab, sites, SMOs) and coordination of team member activities.
Performs initiation, interim and close-out site visits in accordance with SOPs when applicable.
Assists in the development of comprehensive subject recruitment strategies and monitors enrollment to assure compliance with clinical milestones.
Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management. May conduct monitoring or accompanied oversight visits to resolve difficult study conduct issues.
Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.
Reviews data tables, listings, and study reports for assigned protocol(s).
A Bachelor's degree or higher in biological science, pharmacy, or other related discipline, or an equivalent nursing degree is required.
A minimum of 2+ years of monitoring experience or equivalent experience in clinical research.
Excellent interpersonal, verbal, and written communication skills, including experience in making presentations.
Other requirements include willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of teamwork. Candidate must be able and willing to travel domestically and internationally 25% to 40% of the time, and possess a valid driving license.
BioPhase Solutions – the right opportunities with the right companies
Our goal is to make a positive impact to science by matching candidate's skill sets with company's needs. Our staff has a reputation for excellence in the industry by developing professional relationships with San Diego’s finest pharmaceutical and biotechnology companies. For immediate response please forward your resume to
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Monster - 6 months ago