Clinical Research Coordinator - Registered Nurse - ON-SITE
VillageMDAbout the role
About Our Company
We’re a physician-led, patient-centric network committed to simplifying health care and bringing a more connected kind of care.
Our primary, multispecialty, and urgent care providers serve millions of patients in traditional practices, patients' homes and virtually through VillageMD and our operating companies Village Medical, Village Medical at Home, Summit Health, CityMD, and Starling Physicians.
When you join our team, you become part of a compassionate community of people who work hard every day to make health care better for all. We are innovating value-based care and leveraging integrated applications, population insights and staffing expertise to ensure all patients have access to high-quality, connected care services that provide better outcomes at a reduced total cost of care.
Please Note: We will only contact candidates regarding your applications from one of the following domains: @summithealth.com, @citymd.net, @villagemd.com, @villagemedical.com, @westmedgroup.com, @starlingphysicians.com, or @bmctotalcare.com.
Job Description
This position is on-site home based in Florham Park, will have regular assignments in Clifton, Saddle Brook and Englewood. Site assignments may change based on evolving needs of the Research Department.
Essential Job functions:
- Together with Research Team and Research Review Committee, work with industry sponsor and physicians to identify appropriate protocols.
- Coordinate and facilitate site qualification visits.
- Assist in evaluation of all potential clinical research studies.
- Exhibit working knowledge of protocol(s), including objectives, rationale, and description of investigational product, inclusion/exclusion criteria, study visits and procedures, concomitant medications.
- Knowledgeable and confident to perform informed consent process; together with investigator, effectuate informed consent process.
- Communicates with sponsor to assure receipt of necessary study supplies (i.e., lab kits, CRFs, tools, investigational product, binders…), documents and maintains logs.
- Identifies study specific lab and ancillary procedures, contacts appropriate personnel within each department, facilitates training, certification, validation/calibration, and establishes workflow(s).
- Assemble and maintain source document binders assuring the most current version of informed consent is available.
- Prepare and distribute study related advertisements/recruitment materials (i.e., brochures, flyers, screening worksheets, physician-to-physician letters, Sound-card).
- Screen patients in appropriate departments and via data base query, if applicable, documents screening efforts and enters information as per protocol requirements.
- Maintain communication and visibility with investigators and support staff to promote and encourage patient enrollment.
- Enroll patients as per protocol.
- Schedule/order patient visits accurately: informed consent discussion, investigator visits, lab, and ancillary as per protocol.
- Promotes protocol compliance by being available at all patient visits.
- Ensures study documentation is complete and accurate; completes CRFs/EDC at time of enrollments and all subsequent visits within 48 hours of visit.
- Responds to queries/data clarifications adequately and within 5 days of receipt.
- Maintains minimum amount of queries/data clarifications.
- Prepare investigational product as per protocol requirements; together with investigator, dispense/administer investigational product, document and log appropriately according to SOP.
- Ensures investigator receives reviews and signs all lab and ancillary tests within 48 hours of receipt.
- Follow enrolled patient for duration of study and ensure follow-up visits, labs, ancillary testing is complete.
- Together with investigator, monitor for adverse events/serious adverse events. Notify investigator immediately of any adverse event/serious adverse event. Notify sponsor/IRB as per protocol requirements. Assure accurate and timely documentation of any adverse event/serious adverse event.
- Inform patient of any changes in protocol, safety information, visit requirement
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