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Regulatory Specialist - Kingsport, United States - Holston Medical Group
Description
If you are a motivated and reliable person with exceptional customer service skills and the ability to thrive in a fast-paced environment, come join Holston Medical Group. We are looking for friendly, courteous employees to ensure a positive patient experience and welcome a teamwork environment.
WHAT WE OFFER:
The Regulatory Specialist is responsible for Submitting all required information, materials, reports, regulatory documents as required by the sponsor/ funding organization, and regulatory authority(ies)managing clinical research activities.
Main Responsibilities:
•Follow HMG-CR SOPs regarding Regulatory and associated processes.
•Submitting all required information, materials, reports, regulatory documents as required by the sponsor/ funding organization, and regulatory authority(ies).
•Ensuring that the study is conducted under the oversight of a qualified IRB.
•For each study, create a series of file folders or start a binder for documents collected during the study (Study Binder)
•Make certain all CVs and medical licenses are current.
•Work with the research coordinator and PI to compile a study summary for training prior to study start-up.
•Track and submit to IRB (where appropriate) all IND safety reports generated during the study (until IRB close-out)
•Closely monitor communication with the IRB and Sponsor for required updated documentation and corrections.
•Maintain copies of all training certificates.
•Develop and maintain updated CVs for all study personnel.
•Maintain and update the file folders or binder as necessary, adding appropriate regulatory documents as they are generated or received.
•Work closely with the IRB, sponsor, and coordinator for submission and approval of all study documents and advertising.
•Obtain financial disclosure information and submit to the study sponsor.
•Accurately generate a form '1572' for each study and update as required.
•Check and record temperatures for investigational drug storage and immediate report any temperature deviations to the PI, DOR, and Team Leader.
•Order and/or obtain dry-ice.
•Work closely with the study team to report regulatory study status.
•Participate in management meetings.
•Ensure that subject records and regulatory files are kept confidential and are stored in a secure, limited-access location.
•Document phone conversations that address the study and/or regulatory, legal, financial matters.
•Work with the Director of Research and Financial Coordinator to determine subject stipend and submit to the IRB for approval.
•When the study is over, review the contents of regulatory files and subject records for completeness by comparing with the checklists. (SOP attachment PM-306-A)
•Keep originals or photocopies of all relevant documentation, including facsimile confirmations and e-mail correspondence and file in the study binder with appropriate documents.
•Copy sponsor/CRO on IRB communications such as SAEs, IND safety reports, IRB acknowledgment of reports received, amendment approvals, revised informed consent form, continuing approval for study.
•Work with the Sponsor, Director of Research, and IRB for development of consent.
•Prior to initiation of study procedures, complete the IRB application and submit to the IRB along with the protocol, informed consent, recruitment material, and other information as required by the IRB.
•Confirm whether or not the sponsor/CRO expects all approval documentation to be in place prior to the Study Initiation Visit or not. If the sponsor provides a consent form, adapt the language to meet HMG-CR requirements. Consult with the sponsor/CRO , if needed, to reconcile local requirements with central requirements. Verify that all required and additional elements of the informed consent form are incorporated by using the Informed Consent Checklist (SOP Attachments SM 402-B, SM 402-C) and inserting the appropriate language as required by the IRB.
•Check fax machines routinely during working days for received faxes that contain confidential information.
•Search for potential subjects using database query, when requested by Process Specialist.
•Work with Team Leaders to assist with document filing when required.
Education/Experience/Knowledge:
•High School Diploma or equivalent required
•1-2 years' experience in a medical office, preferred
•Experience in the conduct of clinical research preferred but not required for application.
•Interpersonal and communication skills - interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
We are an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, age, national origin or disability.
