Clinical Research Coordinator

Summary

Join Vitalief, a leading site solutions partner, as a Clinical Research Coordinator! This fully benefited, 100% remote position supports a boutique CRO in decentralized clinical trials. You will coordinate all aspects of studies, from patient enrollment to data collection and reporting, ensuring compliance with GCP. Collaborate with various stakeholders, including PIs and research teams. The ideal candidate possesses a Bachelor's degree (highly preferred), GCP certification, and at least two years of experience as a CRC, with experience in decentralized trials and remote work. Enjoy a competitive salary, comprehensive benefits (including PTO, life/disability insurance, 401k, and robust healthcare), and a people-first culture.

Requirements

• Possess a Bachelor’s Degree (highly preferred)
• Have Good Clinical Practice (GCP) certification
• Have a minimum of 2 years of experience as a Clinical Research Coordinator
• Have experience working on decentralized trials or working in a fully remote/hybrid role
• Have experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol
• Demonstrate a compassionate, professional demeanor, ensuring a positive first impression and patient experience
• Possess exceptional communication skills to establish rapport with patients and team members
• Have excellent time management and multitasking abilities in a fast-paced environment
• Possess strong organizational skills with meticulous attention to detail
• Have the ability to troubleshoot issues independently and escalate when necessary
• Demonstrate adaptability to changing priorities and a proactive approach to meeting study deadlines
• Be proficient in Microsoft Office (Word, PowerPoint, Excel)
• Have experience with Electronic Health Records systems (i.e. EPIC) and Clinical Trials Management Systems (i.e. OnCore)

Responsibilities

• Work under the supervision of the Director of Clinical Research Operations, collaborate effectively with team members and trial participants; coordinate and execute all aspects of decentralized clinical research studies focused on various therapeutic areas
• Be accountable for successful execution of clinical trials through all phases of the study: protocol-specific tasks including patient screening/enrollment/consenting, ordering tests, data collection, study documentation of patient reported responses, and closeout
• Serve as a liaison (communicating effectively) between, Principal Investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors – to ensure that services are coordinated and delivered to patients in a timely manner
• Demonstrate and promote compliance with good clinical practice (GCP) and applicable law
• Maintain research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in the studies
• Participate in site preparation for trials including protocol feasibility, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents
• Schedule and conduct virtual trial sessions by informing patients and coordinating procedures per protocol
• Assess and triage study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol
• Deliver or exceed project enrollment targets for clinical research studies at their site

Preferred Qualifications

Have any Behavioral Health experience

Benefits

• 20 PTO (Paid Time Off) days plus 9 paid Holidays annually
• Company paid life insurance and short / long term disability coverage
• 401K retirement program
• Robust healthcare plans to choose from