Regulatory Compliance Specialist

Flourish Research

17h•$24 - $28•Remote

About The Position

Flourish Research is actively hiring a Regulatory Compliance Specialist. This role involves preparing, maintaining, and overseeing all research-related regulatory documents. The specialist will populate and coordinate the submission of initial regulatory documents to the IRB, sponsors, and state or federal regulatory offices. They will compile study information and submit reports, prepare and submit updated documents such as Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s, and informed consent documents. The role also includes filing and maintaining regulatory binder logs, assisting with the archival of clinical trial documents, preparing for monitoring visits and audits, and managing employee Curricula Vitae and licenses. The specialist must abide by HIPAA regulations, maintain confidentiality, create error-free written documents, seek additional assignments, perform duties efficiently, and represent Flourish Research professionally. Additional duties may be assigned by management.

Requirements

Bachelor’s degree or equivalent experience
Minimum of 2+ years at CTT plus 103 years’ experience within the field of clinical or biological research.
Exceptional knowledge of clinical research methods.
Consistently demonstrates core values & proficiency of skills set.
Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
Must be detail oriented, organized, self-motivated, be able to work independently and one team, and the ability to stay on task.
Demonstrates excellent interpersonal skills including written and verbal communications.
Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics and other employees.
Demonstrates professionalism, and a strong work ethic.
Must have the ability to adapt and take on additional tasks as requested.
Ability to solve problems while working closely across departments.
Assists with developing and implementing key initiatives in the department.
Assists with identifying and implementing process improvements.
Seeks out opportunities to help achieve department/company goals.
Fosters relationships across teams.
Consistently accomplishes 80% of individual quarterly goals and objectives.
Assists with training and mentoring department new hires.
Demonstrates good critical thinking and decision-making skills resulting in sound judgement.
Industry certified as applicable.
Demonstrated ability to collaborate and align with operations.
Flexible and able to multi-task and prioritize competing demands.
Ability to think independently and influence when appropriate.

Responsibilities

Prepare, maintain and provide oversight to all research-related regulatory documents.
Populate and coordinate the entire process of initial regulatory documents’ submission to the IRB, sponsors and state or federal regulatory offices as necessary.
Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor.
Prepare applicable submission forms and submit updated documents including but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s and informed consent documents.
Accurately file and maintain all necessary logs within the regulatory binder(s).
Assist in and manage the archival of clinical trial documents/records.
Prepare for monitoring visits and audits.
Manage and update full-time and contract employee Curricula Vitae and ensure copies of all current and applicable medical/nursing licenses, certifications and other required regulatory documents are on file.
Abide by all HIPAA regulations.
Maintain confidentiality of sponsor and CTT trade secrets.
Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
Seek additional assignments when other tasks are completed.
Perform all duties in a time- and cost-effective manner.
Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
Additional duties as assigned by management.