PT Research Specialist Nephrology

Grade: T24

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Summary:

The Clinical Research Specialist will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators and Clinical Research Nurse to provide research support requiring the application of standard clinical research practices. The Clinical Research Specialist will participate in the planning, implementation, and execution of Clinical Trials in the Department of Medicine/section of Nephrology at the Temple University Lewis Katz School of Medicine. The focus of the research is to help eliminate health disparities in kidney disease, hypertension, and kidney transplantation.

Essential Functions:

• Assist with screening, tracking and enrolling patients in active clinical trials;

• Obtain informed consent; scheduling and conducting study visits;

• Assist with the preparation of IRB submissions;

• Act as a contact for study sponsors and participants,

• Process and ship laboratory specimens,

• Interact with study sponsors, faculty and staff, and

• Collect and enter study data into study database.

• Schedule and participate in sponsor meetings and resolve queries in a timely fashion.

• Assist with start-up activities for new studies including feasibility review and pre-start up sponsor meetings.

• Support multiple active protocols simultaneously,

• Submit studies to local and central IRBs,

• Maintain regulatory compliance and documentation,

• Submit and update study records on clinicaltrials.gov.

• Work with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies.

At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity.

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

Required Education & Experience:

Bachelor's degree in life science or health professions field and at least two years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. An equivalent combination of education and experience may be considered.

Required Skills & Abilities:

• Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants.

• Ability to operate all standard office equipment/software including MS office.

• Ability to work independently or as a team with attention to detail and adherence to project deadlines.

• Ability to work evenings and weekends if needed.

Preferred

• Prior experience with IRB submissions both local and central.

• Prior experience with OnCore clinical trial management system, Florence electronic regulatory system

• Prior experience using Epic EHR.

• Prior experience using electronic data capture (eDC).

This position is at the Health Science campus. There may be opportunities for hybrid work arrangement at the discretion of Temple University and the Department.

This position requires a background check.

This is a grant funded position.

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.

In accordance with the City of Philadelphia's COVID-19 mandate, all Temple University students, faculty, staff, and contractors working in a healthcare setting must be fully vaccinated before receiving authorization to work unless they have a medical or religious exemption approved by the University. An individual is considered fully vaccinated two (2) weeks following the second dose of the Pfizer or Moderna vaccine or two (2) weeks following a single dose of the Johnson & Johnson vaccine. Individuals who do not meet the University's vaccination or exemption requirement will be prohibited from working until proof of full vaccination or an exemption is requested and approved. For more information, visit the University's Vaccines web page at https://www.temple.edu/coronavirus/vaccines.

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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