Regulatory Program Coordinator

Temple University; Philadelphia (Philadelphia County); On-site; USD 50,000 - 55,000; Full time

Benefits offered by this job

Full medical, dental, vision coverage

Paid time off 11 holidays

Tuition remission for employees and/or

A generous retirement plan

Job summary

Temple University, Lewis Katz School of Medicine, seeks a Regulatory Program Coordinator to support regulatory oversight for Phase I–IV trials. On-site position in Philadelphia with responsibilities including IRB submissions, regulatory documentation, and site monitoring.

The role requires a Bachelor’s degree and at least three years of regulatory/compliance experience in research settings. Grant-funded work with clerical and coordination duties across study teams.

Qualifications

• Bachelor’s degree and at least three years of experience in research and/or regulatory compliance in a research or clinical setting.
• Equivalent combination of education and experience may be considered.

Responsibilities

• Assist to maintain oversight of all regulatory compliance monitoring including internal and external progress reports.
• Prepare and process regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events.
• Organize and maintain regulatory affairs documentation/files.
• Support compliance and quality assurance activities.
• Participate in site visits, monitoring, audit and close out visits.
• Train research personnel on consent processes/forms and regulatory documents.

Skills

Federal regulations

MS Word

MS PowerPoint

MS Access

Education

Bachelor’s degree

Tools

MS Word

MS PowerPoint

MS Access

Job description

Temple University’s Lewis Katz School of Medicine’s Pulm/Critical Care/SleepMed Department is searching for a Regulatory Program Coordinator 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!

Salary Grade: T25 Salary Range: $50,000.00-$55,000.00

Job Details:

• This position will be on-site
• This position requires the following background checks: Cash Handling
• This is a grant funded position

Position Summary:

The Regulatory Program Coordinator, under the supervision of the 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 and Experience:

• Bachelor’s degree and at least three 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.

Responsibilities:

• Assists to maintain the oversight of all regulatory compliance monitoring including internal and external progress reports
• Prepares and processes all regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events
• Organizes and maintains all regulatory affairs documentation/files
• Supports compliance and quality assurance activities
• Participates in site visits, monitoring, audit and close out visits
• Participates in study team meetings, other required group meetings, and ongoing protocol training/compliance meetings
• Assists in the development of investigator-initiated protocols, assists with IND applications and annual reports
• Assists with regulatory compliance guidance oversight of investigator initiated multi-center trials
• Trains research personnel on consent process/forms and the regulatory processes and regulatory documents.
• Performs other duties as assigned

Required Skills & Abilities:

• Demonstrated knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other federal agency requirements governing human subjects research.
• Demonstrated knowledge of quality assurance or auditing functions.
• Demonstrated computer skills, and proficiency with MS Word, MS PowerPoint, MS Access or similar software programs.
• Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population.
• Excellent verbal and written communication skills, including training skills.
• Demonstrated organizational and time management skills, along with the ability to work under tight deadlines.
• Demonstrated ability to be detail-oriented.
• Demonstrated ability to work independently and as part of a team.
• Must maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subjects research.
• Ability to travel to off-site locations that may not be accessible via public transportation.

Preferred:

• Experience with biomedical human research is preferred.

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. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. You may request a copy of the report by calling Temple University’s Department of Public Safety at 215-204-7900.