Clin Research Nurse Coord

Overview

Registered Nurse Coordinator, Oncology Clinical Research

Full Time, 80 Hours Per Pay Period, Day Shift

Thompson Cancer Survival Center Overview:

Thompson Cancer Survival Center is our region's largest cancer-fighting network, with more imaging centers, more board-certified physicians and surgeons, and more cancer and radiation centers closer to where you call home. And, we are a proud member of Covenant Health, our region's top-performing healthcare network with 10 hospitals, outpatient and specialty services, and Covenant Medical Group, our area's fastest-growing physician practice division.

Thompson Cancer Survival Center (TCSC) was founded to bring world-class cancer care to East Tennessee. At Thompson, leading cancer specialists use the most advanced technologies to achieve breakthrough successes in treating many types of cancer. Our doctors have the support of a complete team:
Dieticians, genetics counselors, physicists, pharmacists, therapists, technologists, oncology nurses, social workers and others are all there to treat - and beat - the disease.

Position Summary:

The Clinical Research Nurse Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation.

The Clinical Research Nurse Coordinator performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge. Reports to the Clinical Trials Manager.

Recruiter:
Sandra Simmons ||

Responsibilities

Trial Planning and Strategy

* Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering the ability to maintain the rights, safety, and well-being of the patient and serving as the liaison between the investigator and the sponsor to clarify expectations, goals, procedures, questions, and concerns.

* Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings at the manager's discretion and scheduling and coordinating pre-study site visits, initiation visits, monitoring visits, and close-out visits.

Trial Recruitment and Management

* Manages Subject Recruitment and Enrollment by monitoring enrollment goals and modifying the recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assuring that all screening, eligibility, and enrollment procedures are performed according to protocol requirements by reviewing source documents in the EMR. Attend multidisciplinary conferences/meetings to provide study-related information as needed to the physicians discussed during the conference/meeting.

* Coordinates patient enrollment in clinical trials by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits.

* Manages clinical trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient's response to protocol treatment, accompanying the physician for all protocol-required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.

Regulatory Compliance and Safety

* Maintains federal guidelines for Informed Consent process by communicating information about the protocol, informed consent form and follow-up procedures with potential study patients, conducting interviews to assess the patient's ability and willingness to follow and complete study procedures and visits, obtaining informed consent from the patient prior to any study-related procedures and documenting appropriately.

* Ensures patient safety with ongoing patient education about cardiovascular treatments and disease process. Perform skilled nursing assessments and promptly report all findings to the investigator and study sponsor. Recognize laboratory values and assessments outside of normal limits.

* Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flow sheets,…