Sr Regulatory Program Coord

Temple University • Philadelphia, PA

6d • Onsite

About The Position

Temple University's Lewis Katz School of Medicine’s Pulmonary/Critical Care/Sleep Med Department is searching for a Senior Regulatory Program Coordinator! This position will be on-site and is grant funded. A background check is required prior to commencement of service. This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.

Requirements

• 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.
• Detail oriented
• Excellent interpersonal and communications skills, including the ability to interact with as 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 to 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

Nice To Haves

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

Responsibilities

• 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 IND’s, IDE’s 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).

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior