Clinical Research Associate II – Contractor

Job not on LinkedIn

October 7

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $75 / hour

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

Apply Now

Receive Emails with Similar Jobs

Dynavax Technologies

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals

Dynavax Technologies is a commercial-stage biopharmaceutical company focused on developing and commercializing novel vaccines to combat infectious diseases. The company utilizes proven and innovative adjuvant technology, such as its CpG 1018® adjuvant, to enhance the effectiveness of vaccines, including its HEPLISAV-B® product. With a commitment to making a global impact on public health, Dynavax actively engages in clinical trials and values driven team collaborations to advance its pipeline of vaccine solutions.

201 - 500 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

💰 $200M Post-IPO Debt on 2021-05

📋 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