Sr Regulatory Program Coord

Temple University•Philadelphia, PA

8d•Onsite

About The Position

Temple University's Lewis Katz School of Medicine, Pulmonary/Critical Care/Sleep Medicine Department, is seeking a Senior Regulatory Program Coordinator. Under the supervision of the Senior Regulatory Manager, the coordinator participates in the coordination of active Phase I–IV clinical trials and interacts with study sponsors, principal investigators, and research clinical staff in the Thoracic Medicine & Surgery department. This is a grant-funded, on-site position and requires a background check before commencement of service. The coordinator manages and supports regulatory submissions and documentation for clinical research, including submissions to institutional review boards and other committees, as well as submissions to the FDA. The role involves reviewing study materials and consent forms, maintaining regulatory correspondence and records, supporting monitoring visits and audits, communicating with research stakeholders, tracking program metrics, and completing Clinical Trials Management System tasks. Evening and weekend work may be needed, and travel to study training meetings and off-site locations is required.

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, with excellent interpersonal and communication skills and the ability to interact with a diverse constituent population.
Strong analytical and problem-solving skills.
Demonstrated organizational and prioritization skills, with the ability to work in a dynamic environment and handle multiple tasks simultaneously.
Ability to travel, including by air or car, to study training meetings as required by study projects.
Demonstrated computer skills and proficiency with Microsoft Office Suite programs.
Excellent written and verbal communication skills.
Patient-facing experience.
Ability to work independently and as part of a team.
Ability to travel to off-site locations that may not be accessible by public transportation.
Ability to work evenings and weekends as needed.

Nice To Haves

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

Responsibilities

Submit IRB applications, protocol changes, continuing reviews, and adverse event reports on time, as well as submissions to other applicable committees and agencies.
Support FDA submissions, including INDs, IDEs, and Compassionate Use requests.
Review applications, forms, protocols, and consent forms for validity, readability, consistency, formatting, content, and appearance.
Review and negotiate consent forms to ensure they meet IRB standard language requirements and are clear and understandable.
Maintain correspondence from committees, including IRB, SRC, P&T, PRC, DSMB, and audit committees.
Participate in sponsor monitoring visits, sponsor audits, internal audits, and FDA inspections as assigned.
Communicate timely updates about progress, issues, and requirements to research coordinators, investigators, and sponsors.
Disseminate information about regulatory changes, trends, and precedent-setting occurrences related to new requirements.
Communicate project progress, barriers, and process-improvement ideas to the supervisor.
Share committee correspondence and submission status with principal investigators through research study coordinators; facilitate or initiate revisions and resubmissions when submissions are not approved.
Track metrics to help develop and expand the program.
Consult investigators or outside consultants as needed to determine whether a procedure meets the standard of care in research.
Complete Clinical Trials Management System tasks as required.
Maintain documents in the appropriate file structures and locations, such as network drives and eReg.