Clinical Research Coordinator

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 12%

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Science 37

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💊 Pharmaceuticals

🔬 Science

💰 $200M Post-IPO Equity on 2021-10

Healthcare • Pharmaceuticals • Science

Science 37 is making the promise of virtual trials the new reality. By engaging with patients from the comfort of their own home, we provide access to patients who can never be reached by traditional site-based models. We have proven to enroll faster, retain patients at a higher rate, and reach a more representative population. Science 37 has conducted more decentralized, interventional trials than any other company, using an expansive, in-house network of telemedicine investigators and home-health nurses, who are supported by the industry’s most comprehensive, fully integrated, decentralized clinical trial platform.

📋 Description

• Recruit, enroll, and conduct follow-up of study participants in clinical trials under Principal Investigator and Project Manager supervision • Coordinate trial participation according to protocols, SOPs, GCP/ICH guidelines, FDA regulations, and applicable regulations • Implement and execute clinical trial activities from study start-up through closure • Attend and lead investigator, project, and department meetings and trainings as needed • Serve as temporary Project Manager for smaller studies when needed • Determine participant eligibility with study investigators • Screen participants, present trial details, participate in informed consent, and enroll participants • Support development, review, and distribution of clinical protocols, consent forms, study instructions, and related documents • Coordinate patient care and medication-administration education; maintain investigational drug accountability • Review participant condition changes, adverse events, concomitant medications, protocol compliance, and response to study drug; document findings • Collect, document, enter, and report data accurately and timely • Schedule and participate in monitoring and auditing activities • Maintain knowledge of assigned protocols and ensure compliance with Sponsor, FDA, and IRB requirements • Maintain consent forms, case report forms, SAEs, source documents, and regulatory files • Coordinate clinical research logistics and project objectives • Participate in training and educate personnel and vendors • Collaborate with Project Managers on trial procedures and vendor management • Provide process-improvement solutions and support implementation • Maintain participant confidentiality and a safe research environment in compliance with HIPAA and applicable regulations • Mentor and support other Clinical Research Coordinators • For hybrid trials: act as site/Sponsor point of contact, develop project and communication plans, and collaborate with study and multidisciplinary teams

🎯 Requirements

• Bachelor’s degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills • Advanced degree preferred but not required • Minimum 5 years of pharmaceutical-sponsored clinical research experience, or commensurate education, training, and experience within the clinical research field • ACRP (CCRC) or SoCRA (CCRP) certification highly desired • Experience working with patients in a HIPAA regulated environment • Knowledge of Good Clinical Practice (GCP) and applicable regulatory requirements • Medical and scientific knowledge preferred • Expertise in trial management and clinical research • Expert knowledge of FDA regulations and GCP guidelines • Proficiency with MS Office and Google Suite applications • Expertise in proprietary software • Ability to communicate in English, both verbal and written • Ability to conduct collaborative interaction with cross-functional team members • Ability to work in a decentralized team environment • May require extended or unusual work hours based on research requirements and business needs

🏖️ Benefits

• Potential to convert to Full Time after 6 months • Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences