Clinical Research Nurse Manager

Clinical Research Nurse Manager

The Lewis Katz School of Medicine is seeking a Clinical Research Nurse Manager to assist the Senior Director, Clinical Research Operations, the Regulatory team and liaise with the various hospital departments in accelerating the start-up, maintenance, and closeout activities of clinical studies, primarily by supporting several clinical research teams for the day-to-day activities surrounding clinical research studies, and will ensure compliance with federal, state and university regulations. The incumbent will work with investigators on multiple active protocols and will interact closely with the sponsors from qualification visits to close-out visits. The position will require knowledge and utilization of various systems for clinical trial management.

Grade : T28

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Responsibilities include :

• Conduct site selection and feasibility discussions with industry funders.
• New staff onboarding including updating and maintaining onboarding procedure manual.
• Supervise a team of 20-30 clinical research staff including clinical research RN's, Sr. Research Associates, Clinical Research Coordinators, Research Specialists, and Research Administrators.
• Obtain informed consent, scheduling patient admissions related to study procedures; serving as a patient advocate, and educating and counseling patients and families
• Monitoring and oversight of clinical research staff; observe patient care, and assessing patient status and treatment side effects; maintaining regulatory documentation and managing IRB submissions and follow-ups; and overseeing data collection and management in accordance with trial protocol.
• Perform nursing assessments and procedures when needed
• Assist Sr. Director of Clinical Research Operation and Sr. Director of Clinical Research Administration with issues around site payments / invoice documentation and process, as needed.
• Set up research at satellite sites including : identifying research lab space, identifying equipment needed, knowledge of local regulations, clinic space, writing procedures for staff to follow at the satellite location, ongoing oversight of satellite sites.
• Complete performance review plans for team members.
• Collaborate and assist PI and site level staff to ensure adherence to study protocol and sponsor requirements within ICH and GCP guidelines
• Oversee sites progress towards patient enrollment targets previously agreed with the sponsors. Following up and enforcement of completion of the enrollment log and referral log for PI review with the entire study department team.
• Manage multiple projects as per pre-approved timelines and report development progress and project status
• Provide updates to Sr. Director, Clinical Research Operations around issues with enrollment, staffing needs, education needs, and equipment.
• Meets routinely with teams to discuss and provide education. Provides content for staff meetings.
• Ensuring compliance with regulatory standards related to conflict of interest reporting
• Completing and tracking staff clinic assignments for the entire department
• Assisting Sr. Director, Clinical Research Operations to meet with marketing team to promote clinical trials monthly.
• Attend site initiation visits to provide management oversight.
• Attend site monitoring visits to ensure open communication between study coordinator, study sponsor, and PI.
• Identify potential GCP issues, plan, and implement corrective actions.
• Interview new research staff.
• Facilitate communication with the TUHS staff
• This position requires the following background checks : criminal history review, child abuse clearance and FBI fingerprinting; background check for cash / PII access

Required Education and Experience : Bachelor's Degree and six years of nursing experience in the clinical environment. An equivalent combination of education and experience may be considered.

Preferred Education and Experience : Preferred previous management experience.

Required Skills and Abilities :

Preferred Skills and Abilities :

This position is assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department.

Salary Range : $100,000-$125,000

A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source.

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.

Compliance Statement : In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.

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