Manager, Clinical Trials - Neuroscience - Physician Practice - Hackensack Meridian Health

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The position of Clinical Trials Manager is responsible for the identification, coordination and implementation of research trials for the NSI Faculty. Working in concert with the Medical Director of Neuroscience, and the Administrative Director of New Jersey Neuroscience Institute, the Clinical Trials Manager will review all proposed research protocols with Principal Investigators to ascertain suitability of participation as it pertains to the NJ Neuroscience patient population and review all contracts and budgets proposed by the Pharmaceutical companies. Manages the Clinical Trials Research Nurse team.

A day in the life of a Clinicsl Trials Manager at Hackensack Meridian Health includes:

• Screen patients for entry into research studies, review charts, review patient questionnaires and completed screening sheets.
• Manage Research Nurses and volunteers that are involved in the screening process.
• Assist with the evaluation and treatment of patients entered in research protocols under supervision of Principal Investigator.
• Ensure accurate and rapid implementation of protocols.
• Facilitate all interactions with the Pharmacy, Clinical Laboratory, Nursing related to the implementation of acute and ambulatory protocols as patients present.
• Supervise the collection of data by other hospital personnel, i.e. vital signs, adverse reactions, etc
• Monitor patient responses to study medications and take necessary action to prevent complications.
• Ensure that study drug administration and all aspects of patient monitoring comply with the requirements established by the research protocol.
• Maintain database for patients entered into clinical trials, review hospital charts, organize data, fill out case report forms, and respond to requests for additional information.
• Respond to the Stroke Code at JFK for potential screening of patients for the acute stroke studies.
• Keep inventories of trial supplies.
• Track requests for payments as per budget.
• Attend IRB meetings
• Coordinate site evaluation visits and interact comfortably with the monitors or sponsor delegates while discussing study material.
• Collaborate with the Principal Investigators to educate all parties on the screening criteria for each Clinical Trial (Emergency Department, Clinical Laboratory, 3-Central, etc.).
• Design and implement educational programs for the patient/family of potential trial candidates to ensure their continued participation. Counsel patients and answer their questions regarding the effects of trial medication and interaction with other medications or substances.
• Serves as a resource/mentor to enhance the educational and clinical experience of clinical and support staff in the ambulatory, acute and sub-acute setting. Use medical background to make these sessions more interactive and informative.
• Identifies patient care and nursing staff needs which would benefit from research studies or performance improvement activities.
• Analyzes, utilizes and disseminates research findings in clinical practice.
• Provide monthly performance improvement statistics for per cent on time patient contacts and per cent on time IRB submissions, percent on changes to case report form by monitors.
• Attends yearly coordinator conferences.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Understanding of pharmacokinetics and pharmacodynamics of drugs/medications used in clinical trials.
• Minimum of 5 years of experience.
• Familiarity with basic computer and office equipment;
• ability to assist with physical and neurological examination, perform EKG/TCD testing and phlebotomy, and process of samples

Education, Knowledge, Skills and Abilities Preferred:

• Clinical Trials background preferred.

Licenses and Certifications Required:

• NJ State Professional Registered Nurse License.
• AHA Basic Health Care Life Support HCP Certification.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!