Regulatory Specialist

Flourish Research•Walnut Creek, CA

6d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Regulatory Specialist to join our team at our Walnut Creek, CA site. This role is crucial for supporting our clinical research studies by managing regulatory documents and activities throughout the entire trial lifecycle, from start-up to closure. The Regulatory Specialist will work closely with site leadership, principal investigators, site staff, sponsors, CROs, and IRB staff. This position requires a strong understanding of regulatory requirements, excellent organizational skills, and the ability to maintain confidentiality. The role is primarily focused on study start-up, delegation, and training, addressing the increasing complexity and volume of protocol start-up requirements and regulatory tasks. Timely delegation and training of staff are critical for the site to meet revenue goals and maintain quality.

Requirements

High School Diploma, or equivalence.
0-3+ years’ experience within the field of clinical or biological research.
Experienced with Microsoft office applications (Outlook, Word and Excel).
Experienced with a CTMS system, eRegs/eDocs, and other internet-based platforms.
Detail-oriented, organized, self-motivated.
Able to work independently and on a team.
Ability to stay on task and meet deadlines.
Excellent interpersonal skills including written and verbal communications.
Moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite sites and other employees.
Good critical thinking and problem-solving skills.
Professional and have a strong work ethic.
Ability to adapt and take on additional tasks as requested.
Ability to problem solve while working closely across departments.
Assists with key initiatives/process improvements in the department.
Assists with training company new hires.
Completes at least 80% of goals annually.
Excellent computer skills to include Office365 products.

Nice To Haves

College degree preferred.

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.
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 Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s, and informed consent documents.
Accurately file and maintain all necessary logs within the appropriate regulatory repositories.
Assist in and manage the archival of clinical trial documents/records.
Prepare for monitoring visits and audits.
Manage the distribution, collection, processing, and tracking of Essential Site Regulatory Documents for all ongoing studies, including updated Investigator, Pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates.
Maintain confidentiality of study protocol information and Protected Health Information (PHI).
Create error-free written documents and reports (e.g., cover letters, notes-to-file, memos).
Perform all duties in a safe and prudent manner.
Perform all study-related duties in a time-and-cost-effective manner in adherence with Flourish policies.
Represent Flourish Research in a professional and courteous manner when interacting with staff, sponsors, CROs, IRBs, participants, and other medical professionals.
Additional duties as assigned by management.