Clinical Research Coordinator III

Company: Summit Health Inc
Location: Jersey City
Posted on: May 25, 2023

Job Description:

Career Opportunities at Summit Health and CityMD

Summit Health and CityMD form a physician-driven, patient-centric network, committed to simplifying the complexities of health care and bringing a more connected kind of care. Our unique network was created by the 2019 merger between Summit Medical Group, one of the nation's premier independent multispecialty medical groups, and CityMD, the leading urgent care provider in the New York metropolitan area. Together, Summit Health and CityMD deliver a more intuitive, comprehensive, and responsive care experience for every patient, regardless of the stage of life or health condition, through high-quality primary, specialty, and urgent care.

We are continually growing to meet the needs of our patients and deliver exceptional care to an even greater population. Summit Health now has more than 2,800 providers across more than 80 specialty areas, 13,000 employees, and over 370 locations in New York, New Jersey, Connecticut, Pennsylvania, and Central Oregon. CityMD has over 150 locations across the tri-state. We share a vision of improving the way health care needs are addressed by offering timely, high-quality, comprehensive care with an exceptional patient experience. Together, we provide the best possible care to every patient in every neighborhood.

Join our team!

Summit Health and CityMD are dedicated to hiring and retaining the right talent who will contribute to our ongoing expansion and success. We work to set clear goals and expectations, while regularly managing performance and cultivating personal and team capabilities within a positive, collaborative environment that recognizes and rewards success. We strive to make each team member's experience at our company inspiring. Explore our open positions and apply to become a part of the Summit Health and CityMD family.

Job Description

Essential Job functions:

• Together with Research Team and Research Review Committee, work with industry sponsor and physicians to identify appropriate protocols.
• Daily review of physician schedules for new diagnosis, change in diagnosis/treatment for entry onto oncology patient tracker.
• Assist in completion of completion of study start up and ongoing documents, including IRB submission.
• 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.
• 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.
• Submit documents to sponsor, CRO and/or IRB.
• File regulatory documents, correspondence and communication approximately in a timely manner.
• 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 5 days of visit.
• Responds to queries/data clarifications adequately and within 5 days of receipt.
• Maintains minimum amount of queries/data clarifications.
• 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 licensed clinical research coordinator and investigator, monitor for adverse events/serious adverse events. Notify licensed clinical research coordinator and 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.
• 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.
• Prepares patient for investigator visit by obtaining medical history, concomitant medications, vital signs, questionnaires, lab/diagnostic results, and change in health status.
• Able to complete IATA training and lab specimen shipping. General Job functions:
  • Ensure compliance with Standard Operating Procedures. 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:
          • Clinical Research Profession Certification 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. Total Rewards at Summit Health CityMD
            
            Our team members are essential to our mission to reshape healthcare through the power of connection. Summit Health highly values the critical role that health and wellness play in the lives of our team members and their families. We strive to provide a valuable suite of benefits, wellness programs, compensation, time off, and resources to support the wellbeing and personal needs of team members and their families at various stages of life and in their professional career. Collectively, we call these "Total Rewards".
            
            Here at Summit Health, our total rewards include, but are not limited to:
            • We've Got You Covered - Health coverage is vital, and it begins as soon as the 1st of the month after you start employment.
              
            • Build a Healthy Foundation - Various medical plan options, HDHP with HSA option and employer contribution, and waived copays at CityMD Urgent Cares.
              
            • Enhance Your Health Coverage - Dental and vision insurance, plus healthcare and dependent care spending accounts.
              
            • Safeguard Your Household - Company paid EAP and life insurance, plus optional supplemental life, pet, and legal plan insurance.
              
            • Protect Against the Unexpected - Voluntary benefits including hospital indemnity, accident, critical illness, and disability insurance.
              
            • Retirement Investing - 401(k) plan with company match every pay period to help you build towards your retirement.
              
            • Work/Life Balance - Paid time off including PTO, holidays, and more so employees can take a break or care for themselves and their family.
              
            • Paid Maternity Leave - Paid time off for the birth of a child to assist with important time away while welcoming the newest addition to your family.
              
            • Reach Professional Goals - Tuition reimbursement, annual compensation and bonus program, and internal growth opportunities.
              
            • Financial Wellness - Educational webinars, resources, and tools to help foster financial literacy.
              
              
              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/.

Keywords: Summit Health Inc, Jersey City , Clinical Research Coordinator III, Healthcare , Jersey City, New Jersey