Clinical Research Coordinator

Overview:
Vitalief is a leading site solutions partner focused on improving the value and contribution of clinical trial sites across the drug development lifecycle.  With deep expertise in Consulting (strategic and operational) and Functional Service Provider (FSP) services, we provide fully integrated solutions that streamline clinical trials, improve patient outcomes, and drive value for Sponsors, CROs, and sites. 

We are seeking a motivated and detail-oriented Clinical Research Coordinator to work as a Vitalief full-time fully benefited employee, and assist our client, who is a full-service boutique CRO, in support of various decentralized clinical trials.

WHY VITALIEF? 

• You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
• We give everyone a seat at the table – we encourage innovation.
• Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
• Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range: $55,000 to $75,000 - based on experience level.
                                                         
Work Location & Hours: 100% Remote role – work hours are standard business hours Monday through Friday based on Pacific Coast Time Zone (PT).  We will only consider candidates that live in the Pacific or Mountain Time Zone!

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.
• 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.
• Serves 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.
• Demonstrates and promotes compliance with good clinical practice (GCP) and applicable law.
• Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in the studies.
• Participates in site preparation for trials including protocol feasibility, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents.
• Schedules and conduct virtual trial sessions by informing patients and coordinating procedures per protocol.
• Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol.
• Delivers or exceeds project enrollment targets for clinical research studies at their site.

Required Skills:

• Bachelor’s Degree (highly preferred); Good Clinical Practice (GCP) certification is required.
• Minimum of 2 years of experience as a Clinical Research Coordinator, and experience working on decentralized trials or working in a fully remote/hybrid role.
• 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.
• Any Behavioral Health experience is a plus.
• A compassionate, professional demeanor, ensuring a positive first impression and patient experience.
• Exceptional communication skills to establish rapport with patients and team members.
• Excellent time management and multitasking abilities in a fast-paced environment.
• Strong organizational skills with meticulous attention to detail.
• Ability to troubleshoot issues independently and escalate when necessary.
• Adaptability to changing priorities and a proactive approach to meeting study deadlines.
• Proficient in Microsoft Office (Word, PowerPoint, Excel).
• Experience with Electronic Health Records systems (i.e. EPIC) and Clinical Trials Management Systems (i.e. OnCore).

PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working at a computer.  Standing, walking, visual perception, talking and hearing.  Lifting up to 20lbs. 
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