Regulatory Specialist

Flourish Research•Walnut Creek, CA

7d•$25 - $27•Onsite

About The Position

Flourish Research is actively hiring a Regulatory Specialist to support our Walnut Creek, CA site. This role is responsible for creating, maintaining, and coordinating regulatory documents and activities throughout clinical research studies. The Specialist will work according to Flourish Research's SOPs, policies, and procedures, applicable federal regulations, medical ethics, ICH, GCPs, IRB requirements, and sponsor protocol requirements. The role involves close collaboration with site leadership, principal investigators, site staff, Sponsors, CROs, and IRB staff. Responsibilities span from study start-up through the duration of the trial and post-closure. 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 staff training are critical for meeting revenue goals and maintaining quality.

Requirements

0-3+ years’ experience within the field of clinical or biological research.
Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as a CTMS system, eRegs/eDocs, and other internet-based platforms.
Must be detail-oriented, organized, self-motivated, be able to work independently and on a team, as well as the ability to stay on task and meet deadlines.
Must possess 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 sites and other employees.
Must have good critical thinking and problem-solving skills.
Must be professional and have a strong work ethic.
Must have the ability to adapt and take on additional tasks as requested.
Ability to problem solve while working closely across departments.
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 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 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 collection of updated Investigator, Pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates, as applicable. This process applies to both paper and electronic files for each study at the site.
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, etc.).
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 (verbal, written, and in appearance) when interacting with Flourish staff, sponsors, contract research organizations (CROs), IRBs, participants, nursing and medical staff members of various clinics, hospitals, and physician’s offices; Flourish Research contract personnel, as well as any other person(s) when carrying out tasks and responsibilities.
Additional duties as assigned by management.
Assists with training company new hires.
Completes at least 80% of goals annually.