Clinical Research Regulatory Coordinator

Job Title:

Oncology Clinical Research Regulatory Coordinator

The Regulatory Associate supports oncology clinical research by managing regulatory maintenance activities for approximately 30 phase II-IV clinical trials. This role focuses on preparing and submitting regulatory documents, coordinating IRB submissions, maintaining study records, and ensuring monitors and study teams have appropriate system access. The Regulatory Associate works closely with Clinical Research Coordinators and Data Coordinators to ensure regulatory compliance, data integrity, and smooth study operations in a collaborative and growth-oriented environment.

Responsibilities

* Support all regulatory maintenance activities for oncology clinical trials within the Thoracic disease group, including managing documentation for approximately 30 phase II-IV studies.

* Prepare, submit, and track IRB submissions to both local and central IRBs, including Advarra and WCG, ensuring accuracy, completeness, and compliance with regulatory requirements.

* Manage regulatory documents such as protocol amendments, consent form changes, financial disclosures, and delegation of authority logs, ensuring they remain current and properly filed.

* Add and update study personnel on clinical trials, ensuring all required documentation and approvals are in place before individuals are engaged in study activities.

* Review regulatory information and upload all required documents to the appropriate systems and portals in a timely and organized manner.

* Assist with monitor visits by coordinating logistics, ensuring monitors have appropriate access to systems, and providing requested regulatory documentation.

* Respond promptly and professionally to email inquiries related to regulatory matters, study documentation, and trial status.

* Collaborate closely with Clinical Research Coordinators and Data Coordinators on the Thoracic team to support study start-up, maintenance, and close-out activities.

* Maintain thorough, accurate, and audit-ready regulatory files that align with institutional, sponsor, and regulatory guidelines.

* Support investigator-initiated IND studies by assisting with relevant regulatory submissions and documentation, as applicable.

* Participate in ongoing process improvements within the regulatory team, contributing to a collaborative, supportive, and solution-focused work environment.

Essential Skills

* Experience in regulatory affairs or regulatory support within clinical research.

* Hands-on experience with IRB submissions, including preparation and submission of materials to local and central IRBs (such as Advarra and WCG).

* Demonstrated ability to manage regulatory documents, including protocol amendments, consent changes, financial disclosures, and delegation of authority logs.

* Familiarity with oncology clinical research and the regulatory requirements associated with oncology trials.

* Strong organizational skills with the ability to manage multiple concurrent studies and deadlines.

* Proficiency in reviewing, organizing, and uploading documents into electronic systems and portals.

* Effective written and verbal communication skills to interact with monitors, coordinators, and other research team members.

* Ability to work both independently and collaboratively within a multidisciplinary research team.

* Strong attention to detail and commitment to regulatory compliance and data integrity.

Additional

Skills & Qualifications

* Experience working specifically with oncology trials, particularly within a Thoracic disease group, is a plus.

* Familiarity with OnCore or similar clinical trial management systems is preferred.

* Experience supporting investigator-initiated IND studies is advantageous.

* Experience with IBC (Institutional Biosafety Committee) submissions is a plus.

* SOCRA or ACRP certification, or active pursuit of these certifications, is highly valued; reimbursement for certification costs may be available upon successful completion.

* Interest in professional growth within clinical research and regulatory affairs, with a desire to advance along a structured career ladder and into potential leadership roles.

Work Environment

This is a full-time, hourly position scheduled for 40 hours per week within a shift window of 6:30 a.m. to 9:30 p.m., with an 8.5-hour workday that includes a 30-minute unpaid lunch (requiring clock-out) and two paid 15-minute breaks. The role follows a hybrid onsite model, with an expectation to work onsite two days per week on flexible days, coordinated via shared calendars for visibility and team collaboration.

During the first month, the position requires five days per week in-office for comprehensive training and onboarding. The environment is office-based and team-oriented, with a supportive regulatory group that values collaboration, welcomes new team members, and encourages professional development. The organization is growing through hospital expansion and strategic partnerships, offering job stability, opportunities for…