Clinical Research Regulatory Specialist

CAREER OPPORTUNITY for professionals seeking longevity with leading Alzheimer's Disease Clinical Research Company in Wellington, FL.

https://www.researchalz.com/

Regulatory Specialist

The regulatory specialist will complete and maintain regulatory documents for clinical trials to ensure protocol, regulatory, standard operating procedures and Good Clinical Practice (GCP) compliance. Reports to Director of Operations. The position requires strong written communication skills, attention to detail, the ability to meet multiple and changing deadlines, and to consult numerous sources for information to prepare documents and assist with responses to IRB and sponsor questions.

Key Responsibilities

• Maintain and Update regulatory documentation throughout the duration of study until study close-out.
• Follow standard operating procedures (SOPs) pertaining to regulatory.
• Maintain current knowledge of regulatory affairs and/or issues set by regulatory bodies (IRB, FDA).
• Report, monitor, distribute and maintain files for all safety information including investigational drug brochures, investigational new drug (IND) safety reports and serious adverse event (SAE) reports.
• Prepare regulatory documentation packets and creates all U.S. Food and Drug Administration (FDA) 1572 Forms and DOA logs for initial submissions. Ensure all necessary forms are submitted to activate protocols.
• Maintain post regulatory documents including protocols, amendments, consent forms, SAE forms, etc.
• Work within required sponsor eRegulatory portals (eg..SIP, Investigator Space).
• Maintain site specific training logs for all new essential documents and revisions of manuals and guidelines throughout study.
• Support Essential Document Communication.
• Notify administration, regulatory, recruitment, and study team including principal investigator (PI) upon receipt and submission of regulatory documents.
• Prepare and submit regulatory documents to the clinical/contract research organization (CRO) and institutional review board (IRB).
• Review initial IRB approved consent form to ensure accurate information and facilitate approval of any site specific changes.
• Provide copy of protocol amendment and revised investigator drug brochure (IDB) after IRB approval.
• Notify site when amendment is IRB approved and attach copy of approved documents along with amendment.
• Maintain staff CVs.
• Ensure documents are current and filed in binders before monitor's visits.
• Track expirations and retrieve current documentation for medical licensures, CVs, and laboratory accreditations.
• Support trial conduct by working closely with clinical research coordinators, Site Directors to ensure resolution of action items.
• Prepare documents for study initiation visit and close out visit.

Requirements

• Minimum of Bachelor's Degree required.
• Experience in/with clinical research strongly encouraged.
• Proficient with Microsoft Word, Excel.
• Training in GCP will be required and provided.
• Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must have ability to prioritize, excellent written and verbal communication skills, and ability to work in a fast-moving environment.
• Ability to collaborate with sponsor/CRO representative(s).
• Maintain confidential information.
• Ability to project a professional, friendly, and helpful demeanor.
• Perform other duties as assigned.

Compensation package includes salary commensurate with education and experience, employee health benefits, including vision and dental paid 100% by employer, bonus program, 401(k), profit sharing and paid vacation.

Work Remotely

• No

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Ability to Commute:

• Wellington, FL 33414 (Required)

Work Location: In person