Regulatory Specialist

Flourish Research; Walnut Creek (CA); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Tuition reimbursement

Parental leave

Employee referral program

Life insurance

Disability insurance

PTO

Job summary

Flourish Research, based in Walnut Creek, CA, seeks a Regulatory Specialist to manage regulatory documents across clinical studies. The role covers start-up, submissions, and ongoing regulatory support onsite at the Walnut Creek site.

The ideal candidate will have strong regulatory knowledge, proficiency with MS Office, and experience with CTMS/eRegs/eDocs. This is a full-time, on-site position with a Monday–Friday day shift.

Qualifications

• Prepare, maintain and provide oversight to all research-related regulatory documents.
• Coordinate submission of documents to IRB, sponsors and regulatory offices.
• Assist in study start-up, delegation and training activities.

Responsibilities

• Prepare regulatory documents and oversee their accuracy.
• Submit initial, continuing and final regulatory materials to IRB/sponsors.
• Maintain logs and archival files for regulatory records.
• Assist in monitoring visits and audits as needed.
• Coordinate collection of site regulatory documents and training certificates.

Skills

Regulatory documentation

IRB submissions

Attention to detail

Communication skills

Education

High School Diploma

College degree preferred

Tools

Microsoft Office

CTMS

eRegs/eDocs

IRB coordination

Job description

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. WESEEYOU. 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 supportour 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:

• 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 reorts 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. B. Prepare for monitoring visits and audits
• 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 task and responsibilities
• Additional duties as assigned by management

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

• Work is normally performed in a typical interior clinical/office work environment
• Local travel may be required
• Ability to sit for extended amounts of time
• Ability to work in a call center environment with occasional distractions and noise
• Extensive computer use
• Occasional evening and weekend work schedules
• Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
• Ability to drive and daily availability of an automobile

Requirements

Education: High School Diploma, or equivalence. College degree preferred; however, is not required.

Experience: 0-3+ years' experience within the field of clinical or biological research.

Knowledge and Skills: Demonstrates core values and all skills set required; 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. F. Must have good critical thinking and problem‑solving skills; Must be professional and 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; 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

Benefits

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.

Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Researchcomplies withthe lawregardingreasonable accommodation for handicapped and disabled employees.