Clin Research Nurse Manager

Temple University's Lewis Katz School of Medicine's Clinical Research Administration Department is searching for a Clinical Research Nurse Manager to join our team!



Become a part of the Temple family and you will have access to the following:

Full medical, dental, vision coverage

Paid time off

11 Paid Holidays

Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE


A generous retirement plan and so much more!

Click here to learn more about the benefits of working at Temple University.



Salary Grade: T28

Learn more about the "T" salary structure.



Salary Range: Up to $120,000.00 per year



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.



Job Details:

*This position will be on-site

* This position requires a background check prior to commencement of service.

*This is a grant funded position



Position Summary:

The Clinical Research Nurse Manager in the Lewis Katz School of Medicine's Department of Research Administration will 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.



Required Education and Experience:

*Bachelor's Degree and six (6) years of nursing experience in the clinical environment with previous management experience.


*Current licensure as a Registered Nurse in the Commonwealth of PA.

*An equivalent combination of education and experience may be considered.



Responsibilities:

*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

Skills:

Background Investigation, Billing, Clinical Medicine, Clinical Nursing, Clinical Research, Clinical Trial, Clinical Trial Management, Content Development, Data Collection, Data Management, Documentation, Federal Laws and Regulations, GCP (Good Clinical Practices), Hospital, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Maintain Compliance, Marketing, Medical Treatment, Medicine, Multitasking, Nursing, Nursing Management, Onboarding, Operations Research, Organizational Skills, Patient Admissions, Patient Care, Patient Education, Performance Reviews, Procedure Development, Progress Reports, Project/Program Management, Registered Nurse (RN), Regulations, Regulatory Compliance, Research Administration, Research Laboratory, Research Nursing, Research Protocols, Side Effects, Staff Requirements, Startup, State Laws and Regulations, Team Lead/Manager, Treatment Evaluation, University/School Regulations, User Documentation



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