Clinical Research Coordinator

Company : Yale New Haven Health System

Country: United States

Location : Bridgeport, Connecticut

Post: Wed, 22 Mar 2023 19:35:56 GMT

Expires: Wed, 19 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

Overview:
To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values – integrity, patient-centered, respect, accountability, and compassion – must guide what we do, as individuals and professionals, every day.

At Bridgeport Hospital, we are committed to providing quality medical care and treatment that is coordinated and centered on the patient’s specific needs. We strive to achieve benchmarks as a Patient Centered Medical Home and provide health care in a setting where patients are at the center of their care team. All employees of Bridgeport Hospital are part of the patients care team and contribute to the team approach of promoting access, continuous, comprehensive care and work to provide quality improvement in the care provided to their patients.

The Clinical Trial Coordinator (CTC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Program Manager and the Principal Investigator. The CTC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CTC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.

EEO/AA/Disability/Veteran

Responsibilities:
1. Coordinates initiation of new research studies

2. Ensures that IRB approval of protocol and informed consent form is obtained prior to initiation of the study.

3. Reviews subject charts, database records, and other sources to screen and identify potential subjects for the
inclusion in study based on criteria described in the protocol inclusion/exclusion criteria.

4. Provide subject care and data collection procedures in adherence with the assigned study protocol and in
accordance with good clinical research principles.

5. Obtains and coordinates subject blood samples, cultures, tissues, and other specimens for laboratory
analysis as described in study protocol.

6. Collects pertinent information and data from subject charts and records, subject interviews, and other
sources. Completes case report forms (CFRs) in accordance with research protocol guidelines. Submits data, resolves and submits queries as required by study within timeframe required by study

7. Maintains accurate records of the receipt, inventory, and dispensation of study drug and materials. Works with the nursing staff to administer study drug to research subjects.

8. Submits data, resolves and submits queries as required by study within timeframe required by study

9. Conducts interviews with physicians to encourage patient recruitment as needed for study enrollment. Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented

10. Advises principal investigator of progress of data collected on a monthly basis Responsible for processing of contract in conjunction with Bridgeport Hospital legal counsel, Sponsor, and Principal Investigator

11. Participates in Investigators Meetings for assigned study as mandated by protocol. Compiles materials necessary for initiation of study protocol for presentation to staff as indicated by protocol guidelines.

12. Compiles and submits reports, documents, and correspondence as necessary to the IRB, sponsor, and
consortium.

Qualifications:
EDUCATION

Bachelor’s degree in a healthcare related field.

EXPERIENCE

Minimum two years of experience in a related healthcare position, or equivalent combination of education and research experience.

LICENSURE

Certified Clinical Research Coordinator (CCRP) and Good Clinical Practice (GCP) preferred.

SPECIAL SKILLS

Excellent communication, negotiation and organizational skills. Excellent clinical judgment. Excellent knowledge of personal computers and related presentation software. Adaptability to a wide variety of processional interactions. Phlebotomy.

PHYSICAL DEMAND

While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is required to stand and walk. The employee must frequently stoop, kneel, crouch, or crawl; talk or hear. The employee must regularly lift and/or move up to 25 pounds, occasionally move and/or lift up to 50 pounds. The specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. The noise level in the work environment is usually moderate. Incumbents as well as external and internal applicants who become disabled must be able to perform the essential job functions with or without the assistance of reasonable accommodation as determined on a case-by-case basis.