Regulatory Specialist

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

About the Job:

We are actively hiring a Regulatory Specialist to support our Walnut Creek, CA site.

Shift: Monday-Friday day shift (40 hours per week)

Location: Onsite, Walnut Creek, CA

FLSA Classification: Non-Exempt

Compensation: $25 to $27 per hour (depending on experience)

PURPOSE: To create, maintain and coordinate regulatory documents and activities throughout clinical research studies conducted by a Flourish Research site according to Flourish Research's SOPs, policies and procedures, applicable federal regulations, medical ethics, International Council of Harmonization (ICH), Good Clinical Practices (GCPs), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. To work closely with site leadership, principal investigators, and site staff. To collaborate with Sponsors, CROs, and IRB staff. Role functions begin at the time of study start-up, continuing through the duration of the trial, and until after study is deemed closed. All responsibilities should be completed in accordance with Flourish Research's Core Values and Employee Manual.

Additionally, a Regulatory Specialist will be primarily focused on study start-up, delegation and training. We are seeing increased complexity and volume of protocol start-up requirements and regulatory tasks. We need additional on-site support to drive start-up processes. Timely delegation and training staff are critical to our site meeting revenue goals for the ROY and maintaining quality.

ESSENTIAL JOB FUNCTIONS:

A. Prepare, maintain and provide oversight to all research-related regulatory documents.

a. Populate and coordinate the entire process of initial regulatory documents submission to the IRB, sponsors and state or federal regulatory offices as necessary.

b. Compile study information and submit initial, continuing and final reorts to the IRB and/or sponsor.

c. 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.

d. Accurately file and maintain all necessary logs within the appropriate regulatory repositories.

e. Assist in and manage the archival of clinical trial documents/records. B. Prepare for monitoring visits and audits.

C. 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.

D. Maintain confidentiality of study protocol information and Protected Health Information (PHI).

E. Create error-free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.).

F. Perform all duties in a safe and prudent manner.

G. Perform all study related duties in a time-and-cost effective manner in adherence with Flourish policies.

H. 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 task and responsibilities.

I. Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

A. Work is normally performed in a typical interior clinical/office work environment.

B. Local travel may be required.

C. Ability to sit for extended amounts of time.

D. Ability to work in a call center environment with occasional distractions and noise.

E. Extensive computer use.

F. Occasional evening and weekend work schedules.

G. Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

H. Ability to drive and daily availability of an automobile.