- Assign Clinical Research trials to staff with guidance from the Clinical Research Manager.
- Assists clinical research staff with technical issues, problem solving and intervention when appropriate, delegates responsibility for elements of the conduct of selected clinical trials. Answers questions from clinical team including but not limited to study protocols, patient concerns, eligibility, scheduling conflicts, and department logistics.
- Makes recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Clinical Research Manager.
- Supervises coverage and time management of Research Clinical staff.
- Collaborate with the manager and director for the development of department research programs. This is demonstrated through coordination of specific research projects in multiple disease conditions. Responsibilities for program development include assisting with feasibility, site selection, IRB document review, and corresponding to investigators, IRB, and sponsors.
- Collaborate with organizational EPIC team to develop tools for Research documentation.
- Assists with educating the clinical team through new process implementation and continuous education.
- Coordinates with the manager, the onboarding and training of new hires to the clinical team.
- Coordinate individual clinical research projects in multiple disease conditions. Project coordination requires meeting sponsor specific training requirements prior to initiation, training team members to delegated duties, supporting regulatory specialist with sponsor communications, maintaining study supply inventory, and supporting monitors during visits.
- Coordinate individual research participant's visits, to meet study requirements at specific protocol timelines, performing physical assessments, patient interviews related study assessments, dispense prescribed study medication, and follow-up on correspondences with patients related to the study.
- Perform timely and accurate updates to protocol management system at Guthrie and the data submission to the sponsor. Maintain study enrollment records from screening to study closure.
- Contribute to the Clinical Research Department team. Support activities of others on the team. Provide cross coverage of research protocols as needed to support the total research department.
- Administering and dispensing experimental medication ordered for that patient by a licensed physician in the dosage prescribed by protocol. Retrieval of medication and assessment of compliance by patient to the protocol.
- Contribute to all functions of the Clinical Research Department team. Support activities of others on the team. Provide cross coverage of research protocols as needed to support the total research department.
- Collaborate with director, manager, research team members and IRB coordinator in developing and revising process flow for research procedures.
- Attend training seminars and conferences as required by sponsor of research study.
- Make presentations of study information to groups of physicians and patients.
- Advise department manager on resource utilization and training needs.
- Perform other duties as assigned by the director or manager.
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Clinical Research Team Supervisor - Sayre, United States - Guthrie Health
Description
MAIN FUNCTION:
Provide oversight and leadership to clinical team of the Research Department. Including but not limited to, Research RNs, Research Coordinators and Research Assistants within the Clinical Research Department of Guthrie.
EDUCATION/EXPERIENCE
Required:
Must have a PA and NY registered nurse license with a minimum of three years clinical experience. Completion of the CITI Basic Research course regarding Human Subject Protection Training is required within one month of employment. Individual must have proficiency with internet, e-mail, databases, electronic medical records, and competency with nursing assessments.
Preferred:
To have graduated from an accredited college/university with a BS in nursing or BS with an RN and clinical research experience.
Experience:
Desire certification through the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Achievement of certification is highly encouraged by three years in the position.
MAIN FUNCTIONS:
OTHER DUTIES:
