Clinical Research Nurse Manager

Temple University; Philadelphia (Philadelphia County); On-site; USD 108,000 - 132,000; Full time

Benefits offered by this job

Paid time off

11 Paid Holidays

Tuition remission - eligible employees

Generous retirement plan

Job summary

Temple University’s Lewis Katz School of Medicine seeks a Clinical Research Nurse Manager to accelerate start-up, maintenance, and closeout activities for clinical studies. You will support study teams, ensure compliance with federal, state, and university regulations, and collaborate with sponsors from qualification visits to close-out visits.

The role requires RN licensure in PA, a Bachelor’s degree, and at least six years of nursing experience with prior management.

Qualifications

• Bachelor's Degree and six 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 RNs, 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.
• 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.
• Facilitate communication with the TUHS staff
• Performs other duties as assigned.

Skills

MS Office

Financial concepts

Multitasking

Written communication

Interpersonal skills

Organizational skills

Analytical skills

Attention to detail

Independent work

Teamwork

Travel

Education

Bachelor's Degree

Job description

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!

#clinicalnursemanager #templemed #templeuniversity

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

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!

Salary Grade: T28

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.

• 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.
• 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.
• Facilitate communication with the TUHS staff
• Performs other duties as assigned.

Required Skills and Abilities:

• Demonstrated computer skills, and proficiency with MS Office Suite software programs.
• Demonstrated comprehension of financial concepts and operations in a University setting.
• Demonstrated ability to multitask and prioritize competing responsibilities.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills, including the ability to interact with a diverse constituent population.
• Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously.
• Strong analytical and problem-solving skills.
• Strong attention to detail.
• Ability to work independently and in a team environment.
• Ability to travel to off-site locations that may not be accessible via public transportation.

Preferred Skills and Abilities:

• Clinical research experience in a University setting.
• Previous experience with clinical trial management software.

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.