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Clinical Research Coordinator

Company: Nuvance Health
Location: Norwalk
Posted on: June 12, 2021

Job Description:

Nuvance Health has a network of convenient hospital and outpatient locations - Danbury Hospital, New Milford Hospital, Norwalk Hospital and Sharon Hospital in Connecticut, and Northern Dutchess Hospital, Putnam Hospital Center and Vassar Brothers Medical Center in New York - plus multiple primary and specialty care physician practices locations, including The Heart Center, a leading provider of cardiology care, and two urgent care offices. Non-acute care is offered through various affiliates, including the Thompson House for rehabilitation and skilled nursing services, and the Home Care organizations.

Summary:

Reports to Director of Clinical Trials or Clinical Research Nurse Lead: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in Oncology therapeutic areas. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations

Major Accountabilities:

  1. Screens patients for study participation e.g. reviews medical record, collaborates with medical & research staff, etc. and procures informed consent.

  2. Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Enters data. Resolves all patient queries.

  3. Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians, Monitors), sponsors, federal regulatory agencies, and other involved parties as required.

  4. Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.

  5. Maintains current regulatory (GCP, HSR) and study specific required training.

  6. Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).

  7. Educates hospital staff about protocols through in-services, written materials and one-on-one interaction, for each study and each patient, and for general marketing.

  8. Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).

  9. Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within scope of practice and training, consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.

  10. Fulfills all compliance responsibilities related to the position.

  11. Performs other duties as assigned.

Location: Norwalk-34 Maple St

Work Type: Full-Time

Standard Hours: 40.00

FTE: 1.000000

Work Schedule: Day 8

Work Shift: 8:30 am to 5:00 pm

Org Unit: 396

Department: Cancer Research

Exempt: Yes

Working conditions:

Essential:

  • Some manual skills / motor coord & finger dexterity
  • Sedentary/light effort. May exert up to 10 lbs. force
  • Generally pleasant working conditions.
  • Some occupational risk

Nuvance Health and its affiliates are Section 501(c)(3) tax-exempt organizations and therefore eligible employees may qualify for forgiveness of certain federal student loans under the Public Service Loan Forgiveness Program.

WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.

We will endeavor to make a reasonable accommodation to the known physical or mental limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation of our business. If you believe you require such assistance to complete this form or to participate in an interview, please contact Human Resources at 203-739-7330 (for reasonable accommodation requests only). Please provide all information requested to assure that you are considered for current or future opportunities.

Keywords: Nuvance Health, New England , Clinical Research Coordinator, Other , Norwalk, Northeast

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