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. Under the direction of the clinical operations management, the Clinical Research Associate II will 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.

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.

• Highly valued personal attributes include: 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.

Skills

• Technical writing
• Cross-functional collaboration
• Regulatory knowledge (GCP, ICH, FDA)
• Site and CRO management
• Data review and TMF management

Education

• BA/BS in Life Sciences or equivalent