Sr Regulatory Program Coord

Temple University's Lewis Katz School of Medicine's Pulmonary/Critical Care/Sleep Med Department is searching for a Senior Regulatory Program Coordinator.

Benefits:

• 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!

Compensation:

Salary Grade: T26

Job Details:

This position will be on-site. This is a grant funded position. This position requires a background check prior to commencement of service. This role is also eligible for our employee referral program—current employees can earn up to $500.

Job Summary:

Sr. Regulatory Program Coordinator under the supervision of the Sr. Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department.

Required Education & Experience:

Bachelor's degree and at least five years of experience in research and/or regulatory compliance in a research or clinical setting. An equivalent combination of education and experience may be considered.

Required Skills & Abilities:

• Detail oriented
• Excellent interpersonal and communication skills, including the ability to interact with a diverse constituent population
• Strong analytical and problem‑solving skills
• Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and perform multiple tasks simultaneously
• Ability to travel, including by air or by car to attend study training meetings as required by study project
• Demonstrated computer skills and proficiency with MS Office Suite software programs
• Excellent written and verbal communication skills
• Patient facing experience
• Ability to work independently and in a team environment
• Ability to travel to off‑site locations that may not be accessible via public transportation
• Ability to work evenings/weekends hours as needed

Preferred:

• Familiarity with the medical and pharmaceutical industries, and related terminology and practices
• Knowledge of FDA regulations and their practical implementation
• CPR certification
• IATA training
• Human Subjects training
• Research certification

Essential Duties:

• Responsible for timely submission of IRB applications, changes in protocols, continuing review and adverse event reports to the IRB and other committees as applicable including Biosafety Committee, Department of Health submission, or Medical Radiation Safety Committee
• Responsible for supporting submissions to FDA including INDs, IDEs and Compassionate Use requests
• Review all forms and applications for validity, readability and consistency between documents
• Review and negotiate consent forms for IRB standard language, readability and content to ensure simplicity and understanding by any person
• Conduct thorough review of materials submitted to ensure proper formatting and overall content and appearance
• Maintain all correspondence from committees (e.g., IRB, SRC, P&T, PRC, DSMB, Audit committees, etc.)
• Participate in sponsor monitoring visits, sponsor audits, internal audits and FDA inspections as assigned
• Maintain clear and timely communications with the research coordinators, investigators and sponsors regarding progress, issues and requirements
• Disseminate information on any regulatory changes, trends and precedent setting occurrences pertaining to new requirements
• Communicate with supervisor progress made on projects, barriers and process ideas to improve speed and efficiency
• Upon response from the various committees, disseminate all correspondence regarding submission status to the principal investigator through the research study coordinator; if submission is not approved, facilitate or initiate the revision of the original documents at the investigator's direction or coordinator request, conferring with the study coordinator to prepare the resubmission
• Track metrics to assist with developing and expanding the program
• Seek advice from the investigator or outside consultants as necessary to determine whether a procedure meets the standard of care in research
• Complete Clinical Trials Management Systems (CTMS) tasks as required
• Maintain documents using the appropriate file structure and location (i.e., network drive, eReg)

EEO, COMPLIANCE AND SAFETY REPORT:

Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law. 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.