Clinical Research Coordinator - Registered Nurse - ON-SITE

Summit Health•Florham Park, NJ

2d•$78,400 - $98,000•Onsite

About The Position

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 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. #INDNurse 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. About Our Commitment 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. Safety Disclaimer Our Company cares about the safety of our employees and applicants. Our Company does not use chat rooms for job searches or communications. Our Company will never request personal information via informal chat platforms or unsecure email. Our Company will never ask for money or an exchange of money, banking or other personal information prior to the in-person interview. Be aware of potential scams while job seeking. Interviews are conducted at select Our Company locations during regular business hours only. For information on job scams, visit, https://www.consumer.ftc.gov/JobScams or file a complaint at https://www.ftccomplaintassistant.gov/. Join our Talent Network! Click the 'Get Started' button below to create a Candidate Home account to stay up to date on our most recent Job Postings! 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. The work we do is changing the lives of our patients, our communities, and each other. Join us as we deliver the care we want to see in the world. Together, we can create better outcomes for all.

Requirements

New Jersey State Nursing License and BLS certification required – RN preferred
2 years clinical nursing experience required
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.
Ability to travel between Summit Medical Group Sites and travel to investigator meetings.

Nice To Haves

Prior Research experience preferred
Clinical Research Certification preferred

Responsibilities

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