Job Title: Clinical Research - Regulatory Coordinator
Position Type: Full Time
General Details
Coordinate and participate in clinical research studies conducted by principal investigator(s) at Mercury Clinical Research, Inc. Coordinate and participate in performing research, database and clerical duties of a routine and technical nature in support of multi-center clinical trials to ensure adherence of protocols and quality of information received.
Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
Responsibilities
- Coordinate and participate in clinical research studies conducted by principal investigator(s)
- Coordinate and participate in performing research, database and clerical duties of a routine and technical nature in support of multi-center clinical trials to ensure adherence of protocols and quality of information received
- Maintain and update site demographics on computer database, log forms received and file as appropriate, prepare reports from database to include in daily/weekly/monthly reports and other reports as requested
- Received and disseminate study related regulatory documents and correspondence from assigned sites, assist in screening documents for completeness and compliance with protocol and appropriate regulations; assist in investigating incomplete, inaccurate or missing documents to ensure accuracy and completeness of data
- Ensure compliance with protocol guidelines and requirements of regulatory agencies; assist in maintaining communications with sites to provide information, track documentation and overall progress of clinical trials and adherence to established guidelines, ensure that study materials and drug kits and investigational products are shipped and re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to supervisors as appropriate; document all conversation in the appropriate database
- Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes
- Coordinate and maintain Investigational Trial Master File- regulatory and reference binder in completion of study start-up regulatory submissions like site questionnaires, P.I. CV’s, financial disclosures, form 1572, medical licenses and regulatory documents not limited to:
- Study Team Contact List
- Investigator/Site Staff Information
- Site Logs
- Study Worksheets and Forms
- Protocols
- Monitoring Visits
- Product Package
- Signatures
- Safety Reporting/Susars
-Institutional Review Board /IRB correspondence
- Laboratory/Site Equipment
- Investigational Medicinal Product (IMP)
- Correspondence
- Miscellaneous * Coordinate and maintain training requirements such as HAZMAT, CITI, IATA, GCP and sponsor specific training modules and eCRF training courses
- Coordinate and assist pharmacy on maintaining pharmacy binder not limited to:
-Contact Details
- Site Team
- Study Protocol
- Pharmacy Manuals
- Site Blinding Plan
- Monitoring Visits
- Communicate regularly with regional data monitors as needed to provide information before and after visits to participating sites; review the monitor’s post visit reports and follow up on problems identified as appropriate
- Attend investigator meetings when needed, web conferences and teleconferences
- Attend routine weekly meetings and other meetings related to the clinical trial; stay abreast of information and changes to study protocol
- Completes study protocol information in clinical trial management system
- Communicate and coordinate with other study personnel as required to include data entry and randomization personnel, pharmacy, laboratories, study sponsors and others as needed for study implementation and routine problem resolution
- Works closely with sponsor monitors during site initiation visits, site monitoring visits, and answer queries when needed
- Responsible for IRB submissions, SAE reporting, continuing approval reports
- Assure compliance of general and study specific regulatory related process with SOP’s, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies
- Develop appropriate regulatory reports and associated documentation in accordance with SOP’s and study specific processes
- Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees and Institutional Review Board, maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CV’s, licenses, site laboratory certification) coordinate Human Protections Training for personnel
- Perform regulatory audits on cooperative group, industry sponsored, and MCR Investigator Initiated protocols at clinical and affiliate sites, and submit findings and recommendations in writing; develop work plans to address findings
- Work closely with sponsor and study personnel on relevant regulatory issues
- Ensure all necessary documents are completed in a timely manner
- Assist supervisor(s) and manager(s) as needed for related job responsibilities
Required Education/Experience
Education
Work requires knowledge of basic mathematical, data collection and research principles normally acquired through an associate’s degree, or a bachelor degree in Clinical Administration preferred.
Experience
Work requires one year experience in research or a clinical administrative setting to become familiar with the basic regulatory techniques and methods used to collect, compile, verify and store information.
Skills, Knowledge, and Abilities
Work requires the ability to understand and follow oral and written instructions generally acquired through a high school education or higher education. Working knowledge of special procedures that are applicable to work performed. Able to document and communicate pertinent information. Knowledgeable and confident in management. Well-organized, thorough in the protocols of human research and data collection. Skilled in refining and translating researcher’s objectives. Data entry/CRT, Typing-Medical, Editing/Proofing, Medical Terminology, Correspondence, Data Verification, Data Coding-General, Microsoft Office, Clinical Trial Management Software.
Work Remotely
Job Type: Full-time
Pay: $18.00 - $23.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- No weekends
Education:
Experience:
- Clinical Research: 2 years (Required)
Work Location: In person