Clinical Research Associate II (Contractor)

Role Summary

Clinical Research Associate II (Contractor). This position can be 100% remote, but must be located in the United States.

Responsibilities

• 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, including but not limited to, informed consent forms, site training materials, monitoring visit templates, CRFs, CCGs, clinical monitoring plans, source document templates, pharmacy manuals, IRT manuals, etc.
• Participate in implementation of study systems and technology including EDC, IRT, eTMF, CTMS, PROs, etc.
• Support the selection of sites and CROs and planning of clinical meetings as needed (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.).
• Support the review and development of study protocols, clinical sections of INDs, and other regulatory submissions.
• Assist with the review of clinical trial data and listings.
• Assist with filing of clinical documents in the TMF, as applicable.
• Daily activities may vary depending on the clinical phase of the program and this role may support more than one study.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.

Qualifications

• 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.

Skills

• 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

Education

• A BA/BS in Life Sciences or equivalent.

Additional Requirements

• None additional beyond listed qualifications.