Job Description
OVERVIEW Vitalief is a leading site solutions consulting company focused on improving the value and contribution of clinical trial sites across the drug development lifecycle. We are partnering with our client in the Las Vegas area, to find a highly motivated, positive and innovative Clinical Research Coordinator to lead in the coordination, management and conduct of clinical nephrology research trials in dialysis centers and physicians’ practices. Our client prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. Our client wants a teammate who is compassionate, purposeful and motivated by meaningful work. This position is a direct full-time employment opportunity with our client.
Salary Range : Market competitive - based on experience level.
Work Location: Five (5) days per week on-site in Las Vegas, NV.
Responsibilities: - Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, accountable for successful execution of clinical trials through all phases of the study: protocol-specific tasks including patient screening/enrollment/consenting, ordering tests, collecting specimens and 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 conducts trial visits 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.
- Accurate and timely data entry into the electronic data entry systems, and timely resolution of all data queries to meet project timelines for database lock.
Required Skills: - Bachelor’s Degree “OR” Certified Clinical Research Coordinator (SOCRA or ACRP) preferred.
- Two (2) years of experience as a Clinical Research Coordinator, with experience managing studies from start up to close out.
- 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.
- Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines.
- Compassionate personality and ability to interact with patients in a clear and confident manner.
- Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment; self-starter with high degree of initiative, urgency, and follow through.
- Proactive and responsive, knowing when to escalate and communicate issues to management.
- Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.
- Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
- Must have strong Microsoft Office skills.
- Any exposure to Electronic Health Records systems (i.e. EPIC) and/or Clinical Trials Management Systems (i.e. OnCore) is a plus.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP
Job Tags
Full time,