Description

Clinical Research Coordinator, Clinical Trials Department

Full-time, 40 hours

Summary:

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 varied therapeutic areas including but not limited to Cardiovascular, Pulmonary, Gastroenterology, Neurology, Endocrinology, Dermatology and Rheumatology. 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.

Responsibilities:

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. Resolves all patient queries.

3.Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians), 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 trainings.

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.Maintain and Model Nuvance Health Values.

12.Demonstrates regular, reliable and predictable attendance.

13.Performs other duties as required.

Education and Experience Requirements:

•Bachelor Degree OR

•Allied Health Professional Degree AND three years job-related experience.

•Minimum 1-year clinical experience in medical field.

•PREFER: Clinical Research experience

Minimum Knowledge, Skills and Abilities Requirements:

•Fluency in medical terminology.

•Knowledge of clinical trials, research and general medicine. Strong computer skills.

•Strong attention to detail and organizational skills

•Outstanding interpersonal skills

License, Registration, or Certification Requirements:

•Basic Life Support current or willing to take course

•Valid Driver’s license

•PREFER: Professional research certification

•PREFER: Basic Life Support

Working Conditions:

Manual: Some manual skills/motor coord & finger dexterity

Occupational: Little or no potential for occupational risk

Physical Effort: Medium to Heavy effort. May exert up to 35 lbs. force

Physical Environment: Generally pleasant working conditions

Company: Danbury Hospital, Location: Norwalk Hospital

Exempt: Yes

Salary Range: $27.91 - $51.83 Hourly, commensurate with experience

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 or 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 ensure that you are considered for current or future opportunities.