Clinical Research Coordinator - Registered Nurse - ON-SITE

Job Title

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 requirements by obtaining updated informed consent as required by sponsor.
• Coordinate monitor visits, ensure all source data is complete, accurate and signed and all CRFs/EDC are complete, all queries/data clarifications have been responded to.
• Available at all times during monitor visits for clarification and corrections.
• Knowledge of and works within guidelines of ICH/GCP and FDA regulations.
• Ensures all regulatory documents are filed in appropriate binder and correspondence/forms are submitted in timely manner; files regulatory documents within 5 days of receipt; maintains neat and orderly binders.
• Ensures safety reports are received, reviewed by investigator, signed/dated by investigator and filed appropriately.
• Prepares patient for investigator visit by obtaining medical history, concomitant medications, vital signs, questionnaires, lab/diagnostic results, and change in health status.

General Job Functions

• Ensure compliance with Standard Operating Procedures.
• Coordinate meeting with physician investigator staff for notification of protocol and training if required.

Physical Job Requirements

• Pushing and pulling, taking frequency and weight into consideration.
• Physical strength to lift objects, push carts, taking frequency and weight into consideration.
• Physical mobility, which includes movement from place to place on the job, taking distance and speed into account.
• Physical agility, which includes ability to maneuver body while in place.
• Dexterity of hands and fingers.
• Balance is maintained during climbing, bending and/or reaching.
• Endurance (e.g. continuous typing, prolonged standing/bending, walking).

Environmental Risks

• Chemicals, Chemotherapy and Fumes
• Loud noises
• Vibration
• Extreme temperatures
• Confined spaces
• Allergens: dust, mold and/or pollen
• Magnetic fields
• Radiation
• Sharps
• Latex
• Combative patients/visitors

Blood-borne Pathogens

• Exposure to infectious hazards, blood, body fluids, non- intact skin or tissue specimens.
• Contact with patients or patient specimens.
• Unplanned of unexpected exposure.

Education, Certification, Computer and Training Requirements

• New Jersey State Nursing License and BLS certification required RN preferred
• 2 years clinical nursing experience required
• Prior Research experience preferred
• Clinical Research Certification preferred
• Ability to communicate in English, both orally and written
• Strong interpersonal and organizational skills
• Ability to perform diverse work assignments with time limitations with a high degree of accuracy
• Ability to use problem solving, critical thinking and priority setting skills
• Experience with standard office equipment (phone, fax, copy machine, scanner, and email/voicemail).
• Experience with standard office technology in a Window based environment.
• Experience with EHR.
• Experience with industry standard EDC/IWRS.

Travel

• Ability to travel between Summit Medical Group Sites and travel to investigator meetings.

Pay Range: $78,400.00 - $98,000.00 Annual

The provided compensation range is based on industry standards and salary determinations will be made based on numerous factors including but not limited to years of experience and location of position.

Total Rewards at VillageMD

Our team members are essential to our mission to reshape healthcare through the power of connection. VillageMD highly values the critical role that health and wellness play in the lives of our team members and their families. Participation in VillageMD's benefit platform includes Medical, Dental, Life, Disability, Vision, FSA coverages and a 401k savings plan.

Equal Opportunity Employer

Our Company provides equal employment opportunities ( EEO) to all employees and applicants for employment without regard to, and does not discriminate on the basis of, race, color, religion, creed, gender/sex, sexual orientation, gender identity and expression (including transgender status), national origin, ancestry, citizenship status, age, disability, genetic information, marital status, pregnancy, military status, veteran status, or any other characteristic protected by applicable federal, state, and local laws.

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