- Performs regulatory management of clinical trials, which may cover submission in the study startup phase through study closeout.
- Prepare, track, and maintain all correspondence and documentation required by the IRB, FDA, and other institutional oversight committees as appropriate for the clinical trials to which they have been assigned.
- Prepares timely submissions of regulatory documents to Sponsor and Central IRB as appropriate.
- Maintain clinical trial regulatory compliance with GCP, institutional, and federal regulations.
- Collaborates with clinical trial coordinators and leadership to maintain up to date clinical trial documentation and retraining.
- Performs internal audits and quality assurance checks on regulatory documents.
- Maintains Investigator Site File (ISF) within eRegulatory system and legacy binders.
- Maintain timely continuing review (CR) submissions.
- Prepare regulatory materials for monitoring visits; serve as primary point of contact for scheduling monitor visits and set calendar holds for finalized visit dates.
- Independently follow-up and resolve all issues related to regulatory concerns and ensure receipt of Sponsor/CRO confirmation and follow up letters for each visit completed.
- Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials.
- Provides guidance and training to research staff to ensure compliance with rules and regulations associated with the department's clinical research studies.
- Reviews SOPs for accuracy and submits yearly reviews as needed.
- Assists in the development and design of training materials and source documents in collaboration with clinical trial staff.
- Monitor IRB communications within the electronic portals.
Assists in submission of Emergency Use applications as needed. - Assists in submission of Investigational New Drug (IND) applications including amendments and reporting.
- Provides eRegulatory training, access, and submit study visit log signature requests to Clinical Research
- Assistants (CRAs) during monitor visits.
Supports leadership in the day-to-day activities of regulatory safety management for patients enrolled on research protocols. - Assists in preparation for audit events.
- Provides reporting of all regulatory activities to department leadership.
- Works collaboratively with team.
- All other duties as assigned.
- Bachelor's degree in a scientific discipline or related field; OR equivalent combination of education and experience.
- Master's degree preferred.
- Minimum 2-5 years of experience in clinical research regulatory or related role within healthcare.
- Must obtain CCRP or CCRC certification within 6 months of exam eligibility.
- Experience conducting audits and assessments in a clinical research setting.
- Thorough understanding of regulatory requirements and guidelines (e.g., GCP, ICH, FDA regulations).
- Demonstrate working knowledge of Quality Assurance and Quality Control procedures in a clinical research environment.
- Demonstrate technical competency, knowledge, and ability to analyze, plan and support QA/QC programs and services.
- Knowledge of clinical research methodologies, protocols, and regulatory requirements.
- Strong attention to detail and analytical skills.
- Proficiency in interpreting and applying regulatory guidelines.
- Must be proficient with Microsoft office applications (Outlook, Word and Excel).
- Must be capable of recognizing, and have the willingness, to resolve errors and issues;
- Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
- Excellent communication and interpersonal skills for effective collaboration with diverse teams.
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
- Proficient in utilizing various software tools and databases for documentation and data analysis.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, or schedule form.
- Must interact and communicate both verbally and in written form.
- Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
- Specific vision abilities required by this job include close vision and the ability to adjust focus.
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Description
JOB SUMMARY:
The Research Regulatory Coordinator will support the department by overseeing regulatory processes across multiple oncology studies of different therapeutic areas, in accordance with local and Federal regulations, institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans.
JOB SPECIFIC DUTIES AND RESPONSIBILITIES:
EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The work environment described here are representative of those an employee encounters while performing the essential functions of this job.
This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.
SAFETY SENSITIVE
This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.
