CenExel · 10 hours ago
Regulatory Coordinator
Gaithersburg, MD
Full-time
Onsite
New Grad, Entry Level
$27/hr - $30/hr
0+ years expCenExel is a leading organization specializing in Phase I to Phase IV clinical trials, known for its quality research facilities and experienced clinical research managers. The Regulatory Coordinator is responsible for organizing and implementing regulatory research documents, ensuring compliance with FDA guidelines and maintaining regulatory documents throughout the research process.
Clinical TrialsHealth CarePharmaceutical
Responsibilities
Collect, prepare, and submit documentation to various sponsors/CROs during study start-up, including:
Submission documents/approvals
Protocol amendments with respective signature pages
Informed consent documents
FDA form 1572
Lab normal result documents
Financial disclosure forms
Delegation of authority logs
Licenses
Reports
Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)
Collect, prepare, and submit documentation to institutional review boards for all ongoing and new trials
Serve as a liaison between the IRB, site, and investigator
Obtain necessary signatures from investigators
Coordinate contracts with third-party vendors
Maintain and track current staff credentials (i.e., CV, certifications, etc.)
Act as a resource to other staff members with regulatory questions
Adhere to existing standard operating procedures, perform training on SOPs for the staff, and draft new SOPs when necessary
Maintain regulatory documents for ongoing trials, and ensure all appropriate regulatory documents are archived at the conclusion of the study
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive
Qualification
Required
0-2 years of experience in clinical research regulatory affairs
Knowledge of 'good clinical practices' for clinical research as defined by the Code of Federal Regulations (CFR)
Demonstrated organizational skills to provide regulatory support efficiently and effectively for multiple clinical trials and projects, providing accurate information in a timely manner
Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs
Knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc
Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner
Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner
Must be self-directed and be able to manage multiple projects and responsibilities
Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately
A critical thinker with strong attention to detail and superb problem-solving abilities
Must be able to effectively communicate verbally and in writing
Benefits
Health Insurance
Dental
Vision
LTD
STD
Life Ins
401k
Company
CenExel
CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2025-04-12Acquired
2023-04-01Private Equity
Leadership Team
Patrick McLaughlin
Chief Operating Officer
Recent News
2026-02-05
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