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Clinical Research Associate II – Contractor
Job Description:
- Help to execute assigned clinical studies and ensure studies are completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives
- Daily activities may vary depending on the clinical phase of the program and may support more than one study
- Collaborate with contract research organization (CRO) personnel and study sites to ensure studies are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, SOPs and overall clinical objectives
- Manage study deliverables, including clinical study start-up activities, clinical supply logistics, enrollment, data collection, and close-out in consultation with study leads
- Participate in on-site and remote monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits
- Review monitoring visit reports and track resolution of action items
- Actively participate in the preparation of study-related clinical documents
- Support the selection of sites and CROs and planning of clinical meetings as needed
- Assist with the review of clinical trial data and listings
- Assist with filing of clinical documents in the TMF, as applicable
Requirements:
- A BA/BS in Life Sciences or equivalent
- 2+ years of clinical research associate experience in the biotechnology industry, sponsor experience preferred
- On-site monitoring proficiency required
- Deep working knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials
- Ability to exercise independent judgment and use critical thinking to analyze problems which may require multiple factors and approaches
- Excellent technical writing skills
- Experience working in cross-functional project teams
- Strong verbal and written communication and interpersonal skills
- Computer proficiency a must
- Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers
- Occasional travel required, as needed
- Integrity and flexibility
- Proactive in identifying potential problems and seeking successful solutions
- Action- and goal-oriented
- Practical approach to clinical and regulatory processes
- Collaborative and team-oriented
- Excellent attention to detail
Benefits:
- Highly flexible work environment for headquarter employees
- Gather for in-person meetings when necessary
