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Reports to the Nurse Manager, Clinical Research. Is responsible for the coordination and delivery of primary care to BMG research patients entered on clinical research studies. Provides support to the patient (and caregiver) throughout the continuum of care. Completes the evaluation, documentation, research and submission of data to the sponsoring group. Utilizes in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection to ensure compliance with protocol and regulatory requirements.

• MISSION: We deliver outstanding care, inspire health, and connect with heart.
• VALUES: Trust. Respect. Integrity. Compassion.
• SERVICE GOALS: Personally connect. Keep everyone informed. Be on their team.

Assists in the coordination of the clinical research program of BMG by:

• Assessing the eligibility of candidates for clinical research studies through a thorough review of the patient's history and physical, including hospital and clinical records.
• Coordinating the informed consent process in conjunction with the Physician, patient and their caregiver(s).
• Meeting with patient and caregivers to outline proposed study, time frame, study requirements and providing education on the diagnosis and proposed treatment.
• Continually monitoring study compliance through accurate documentation of toxicities and through the completion of treatment, which includes coordinating treatments, laboratory and radiological studies and other designated procedures for protocol compliance (serum and tissue submissions as required).
• Assessing adverse events and following up with the Physician, patient and sponsor as needed. Reporting all serious adverse events immediately to investigator and within 24 hours to sponsor. Also completing required documentation according to sponsor, regulatory and company policies.
• Following the Federal government guidelines with regard to assurances and Institutional Review Board (IRB) approval for research involving human subjects.
• Assessing the patient's physical status and, if necessary, ordering any study-required testing (such as radiology, labs, etc.) that has not yet been completed by the patient.
• Providing ongoing education to the patient and caregivers on the treatment (i.e., side effects of the treatment, when to seek assistance, what is serious, how to assess response to treatment) and encouraging ongoing dialogue with healthcare professionals.
• Ensuring ongoing communication with study participants to ensure their understanding of protocol and compliance - - for example, answering questions from the patient (or care giver) throughout the duration of the program.
• Coordinating compliance of procedures required by protocol through ensuring accurate communication between the investigator, patient, nurses, Memorial Hospital staff and Physician staff.
• Monitoring patients' medication dosages according to protocol requirements.
• Registering and randomizing eligible patients to consent research protocol study.
• Coordinating and monitoring the plan of care from assessment of eligibility to follow-up care after completion of protocol treatment. Also coordinating and monitoring the patient, Physician and protocol for complete compliance to plan of care.
• Coordinating, preparing and attending clinical monitoring visits. Also, ensures all appropriate clinical research protocols are completed 48 hours prior to monitoring visits.
• Serving as the primary contact for the sponsor or clinical research officer and resolves inquiries within required timeframes.
• Conducting study closeout procedures according to sponsor specifications and company policies, including return of all study product.

Ensures the accuracy and timeliness of all data by:

• Submitting accurately completed protocol data to the sponsoring group in a timely manner as dictated by specific protocol.
• Checking for accuracy of the data submitted.
• Maintaining contact with clinical trial biostatistical centers to ensure data submission is accurate and timely.

Performs other functions to maintain personal competence and contribute to the overall effectiveness of the department by:

• Maintaining records of study medications from cooperative centers for distribution to study participants. Also assisting Physicians in the distribution of protocol medications.
• Assisting with scheduled audits by cooperative groups or sponsoring pharmaceutical companies.
• Monitoring subjects who are (or have been) enrolled in clinical trials from their entry into the program through lifetime follow-up reports.
• Assisting the Physician, nurse and research team with determining clinical trial eligibility, protocol selection and treatment planning.
• Preparing reports as required by departmental guidelines.
• Completing other job-related assignments and special projects as directed.

Associate complies with the following organizational requirements:

• Attends and participates in department meetings and is accountable for all information shared.
• Completes mandatory education, annual competencies and department specific education within established timeframes.
• Completes annual employee health requirements within established timeframes.
• Maintains license/certification, registration in good standing throughout fiscal year.
• Direct patient care providers are required to maintain current BCLS (CPR) and other certifications as required by position/department.
• Consistently utilizes appropriate universal precautions, protective equipment, and ergonomic techniques to protect patient and self.
• Adheres to regulatory agency requirements, survey process and compliance.
• Complies with established organization and department policies.
• Available to work overtime in addition to working additional or other shifts and schedules when required.

Education and Experience

• The knowledge, skills and abilities as indicated below are normally acquired through the successful completion of a Bachelor's or associate degree in nursing. A current license to practice as a Registered Nurse in Indiana is required. Two years of clinical nursing experience is required. Phlebotomy skills are desirable. A Licensed Practical Nurse with at least one year of research experience will be given consideration.

Knowledge & Skills

• Requires a solid base of clinical knowledge that is necessary in order to communicate with Physicians, medical personnel and to teach patients and their families.
• Demonstrates a high level of analytical skills necessary to assess the patient and participate in the care of the patient throughout the course of planned treatment.
• Must be self-motivated, self-directed and detail oriented.
• Requires the organization skills necessary to organize and maintain a record-keeping system using a computer and paper files.
• Demonstrates proficiency in basic computer skills (i.e., data entry, word processing and spreadsheets). A basic understanding of database applications is desired.
• Demonstrates a clear understanding of the concepts of case management.
• Demonstrates the interpersonal and communication skills (both verbal and written) necessary to work effectively with diverse groups and build/maintain working relationships (for example, with sponsoring groups).
• Requires the ability to interact in a professional, sincere and caring manner.

Working Conditions

• Works in an office environment.
• Travel between physician offices is required.
• Must be flexible with work schedule to accommodate patients, sponsors and investigators.

Physical Demands

• Requires the physical ability and stamina (i.e. to walk/stand for prolonged periods of time, push carts/wheelchairs, lift up to 50 pounds, to position/lift patients at a maximum of 35 pounds without assistance, provide CPR, etc.) to perform the essential functions of the position.