Regulatory Coordinator

CenExel•Gaithersburg, MD

6d•$27 - $30•Onsite

About The Position

Responsible for the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Requirements

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.

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.