Clinical Research Associate (CRA) Position Description
The Clinical Research Associate will report to the AVP, Clinical Operations and will be responsible for managing our clinical trials. The successful candidate will be a key interface with our contract research organizations (CROs), other vendors in support of our clinical trials, and clinical sites. In addition, the appropriate candidate will be responsible for all aspects of trial implementations and have oversight of clinical trial CROs and vendors. The successful candidate will work closely with the AVP, Clinical Operations and other Development/Rocket team members on clinical trial operations, timelines, and financials.
Specific Responsibilities will include:
• Must meet all requirements for CRA position and have demonstrated proficiency in all relevant areas
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required
• Assures site compliance with the routine protocol and regulatory requirements and quality of data
• May resolve routine monitoring issues
• Assists in the setting and updating of study timelines
• Assists in CRO or vendor selection
• With guidance from supervisor coordinates CROs or vendors
• May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports for regulatory filings
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
• May participate in abstract presentations, oral presentations and manuscript development at national/international conferences
• Interface with team members in other functional areas to address routine study issues
• Travel is required within the USA, EU, etc.
• At least 5+ years of experience and a RN, BSN, BS or BA in a relevant scientific discipline
• Excellent verbal, written, interpersonal and presentation skills are required
• Working knowledge and experience with Word, PowerPoint and Excel
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures
• Ability to develop tools and processes that increase measured efficiencies of the project
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
• Must have a general understanding of functional issues and routine project goals from an organizational perspective
• A successful candidate will have clinical experience with rare/Orphan disease products and/or gene therapy clinical trials
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com