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Job Description
Position Summary:
Rutgers, The State University of New Jersey is seeking a Clinical Trials Specialist within the Office of Human Research Services-Clinical CRC at the Rutgers Cancer Institute. The Clinical Trials Specialist ( CTS ) serves as the chief contact for all new research patient referrals. The Clinical Trials Specialist will work with members of the clinical research team to navigate research patients through the health care system, ensuring appointments are given in a timely manner through guidelines agreed upon with the Medical Director of OHRS . This position will serve as an essential link between potential study participant referrals and physician providers. Other responsibilities include assisting with access issues, developing relationships with referring health care providers/ CINJ departments, and ensuring the complete and efficient management of all referrals, including acquisition of necessary patient care materials and medical records; this also includes facilitating patient appointments, including those made with labs, diagnostic areas, and CINJ Investigators. In addition, the position will track all new research patient referrals; provide monthly statistics and referring patterns. Essential Duties and Responsibilities include the following:
Protocol Activation:
Collaborates with Protocol Activation office to initiate and activate all new clinical trial protocols assigned utilizing Oncore Study-start up task list. This includes but is not limited to preparation and/or review of study tools such as study binders, medication diaries, eligibility checklists and flow sheets (as required); verification of Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans and finance/contract approvals prior to study activation.
Reviews protocol:
collects multidisciplinary logistical, educational and financial feedback to identify potential obstacles to safe, effective study conduct; actively identifies and resolves obstacles in collaboration with the Principal Investigator (PI).
Patient Referral, Screening, and Registration:
Collaborates with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials. In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patient's charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed. Follows the required elements of the informed consent process to ensure that IRB approved informed consent has been obtained, signed, placed in the medical record, and that a copy was provided to the patient. Obtain informed consent for non-therapeutic studies as assigned in accordance with IRB, GCP, and institutional policies and procedures. Registers consented research patients with study sponsor (e.g., industry, NCI Cooperative group, etc.) and inputs into the OnCore® clinical trials database maintained by the Cancer Institute of New Jersey.
Clinical Responsibilities:
Serves as an essential link between patients and all other members of the research team. Answers patient telephone calls. Correctly processes information for appointment scheduling, answer questions, and assists with problem solving. This includes but is not limited to triaging emergent/urgent phone calls, inquiries related to the availability of clinical trials, scheduled appointment dates and times, parking, direction, and general CINJ practice information. Actively identifies, addresses, and communicates to study team and supervisor any challenges with completion of protocol required procedures and/or adherence to protocol required timelines. Ensures protocol-specific orders are executed accurately, including scheduling and completion of tests and appointments internal or external to the health system as dictated by the protocol and eligibility work-up requirements through the end of study transition to next site of care. Coordinates patient reimbursement while on clinical trial, including Rutgers issued or study-specific ClinCards. Coordinates the clinical assessments and patient care of study participants, with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and GCP guidelines. Documents protocol-related patient contacts, concomitant patient medications, and utilizes applicable institutional templates.
Minimum Education and Experience:
Bachelor's Degree in a social science or related field is required, Nursing degree preferred. Minimum of three (3) years of clinical research experience required.
City:
New Brunswick State:
NJ Physical Demands and Work Environment:
PHYSICAL DEMANDS
Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25 lbs.
