Clinical Research Coordinator - Cancer Institute - Danbury, CT (On-site)
Description
At Nuvance Health, we enjoy the benefits of a two-state system as we cultivate an inclusive culture where everyone feels welcomed, respected and supported. Together, we are a team of 15,000+ strong hearts and open minds. If you share our values of connected, personal, agile and imaginative, we invite you to discover what’s possible for you and your career.
Danbury Hospital, a 456-bed acute care hospital, has been providing award-winning, personalized patient care to the people of Western Connecticut for 140 years. Our specialty areas of excellence include a Level III NICU, a certified Thrombectomy-Capable Stroke Center, and compassionate psychiatric care, including a partial-hospitalization program.
Our accolades include the following:
- The Leapfrog Group - Grade A for quality and patient safety
- U.S. News & World Report - High performance in heart failure treatment
- Healthgrades - One of America’s 50 Best Hospitals
- Surgical Review Corporation (SRC) - Robotic Center of Excellence
- Joint Commission - Gold seal of approval in spine surgery
At Danbury Hospital, we take great pride in our team members and their passion for providing the best care possible—always with heart. For many of our team members, that care extends beyond the walls of our hospital. We volunteer at local non-profits and participate in community initiatives and events. Our dedication to the health and well-being of our entire community makes this a truly special place to work.
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.
Responsibilities:
Major Accountabilities:
- Screens patients for study participation e.g. reviews medical record, collaborates with medical & research staff, etc. and procures informed consent.,
- Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Enters data. Resolves all patient queries.
- 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.
- Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
- Maintains current regulatory (GCP, HSR) and study specific required trainings.
- Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
- 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.
- Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
- 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.
- Fulfills all compliance responsibilities related to the position.
- Performs other duties as assigned.
Requirements:
- Bachelor’s Degree, Allied health professional degree, or equivalent experience.
- Minimum of one-two (1-2) years’ experience with EDC and CRFs.
- Minimum Knowledge, Skills and Abilities Requirements: Ability to multi-task and work as a team and independently.
- Knowledge of Medical Terminology, good clinical practice, FDA, OHRP, and HIPAA policies.
- Outstanding interpersonal communication skills.
- Strong attention to detail, self-motivation, and good organizational skills.
- Ability to prioritize quickly and follow directions and protocol.
License, Registration, or Certification Requirements:
- Basic Life Support (BLS) certified or willing to obtain upon employment. Valid driver’s license and reliable transportation. PREFER: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or certified within 2 years. Oncology experience is a plus.
Department: Cancer Research
Exempt: Yes
Salary Range: $27.91 - $51.83 Hourly, commensurate with experience.
With strong hearts and open minds, we’re pushing past boundaries and challenging the expected, all in the name of possibility. We are neighbors caring for neighbors, working together as partners in health to improve the lives of the people we serve. If you share our passion for the health of our communities, advance your career with Nuvance Health!