Regulatory Specialist
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include based on content. We have: - About Us (company description) - maybe not needed as a heading? Could be "About the role"? Actually "About the role" is a heading for job description. The posting includes "About the Job:" which is essentially about the role. So we can have
About the role
with content from that section. - Responsibilities: The posting includes "PURPOSE:" and "ESSENTIAL JOB FUNCTIONS:" and subpoints. So we can have a Responsibilities section with list items. - Requirements: The posting includes "Requirements Education:", "Experience:", "Knowledge and Skills:" etc. So we can have a Requirements section. - Benefits: The posting includes "Benefits" list. - Pay: The posting includes "Compensation: $25 to $27 per hour (depending on experience)". So we can have Pay section. - Schedule: The posting includes "Shift: Monday-Friday day shift (40 hours per week)". So we can have Schedule section. - Possibly "Qualifications" could be merged with Requirements. But we can just use Requirements. - Skills: Could be part of Requirements. We need to avoid duplication and boilerplate. Remove EEO statements etc. We need to preserve all substantive information. We need to output only HTML fragment, no /, no markdown fences. We'll produce something like:About the role
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.
But we might want to separate purpose into Responsibilities. Better: Have About the role short paragraph, then Responsibilities list, Requirements list, Benefits list, Pay, Schedule. We need to ensure we don't repeat info unnecessarily. Let's extract substantive content: About Us: company description - could be omitted? The instruction says we can include About the role but not About Us? The heading list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. About Us is not in list, but we could incorporate some of it into About the role? Probably not needed. The job posting already has "About the Job:" which is about the role. So we can use that. Thus:About the role
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.
Now Responsibilities: list of essential job functions. We need to extract bullet points from "ESSENTIAL JOB FUNCTIONS:" and subpoints. Let's list them: - 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. - 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 Also there is "PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:" which could be part of Requirements or maybe separate but not in heading list. Could be included in Requirements as notes. We'll include physical requirements under Requirements maybe. Now Requirements: Education, Experience, Knowledge and Skills. 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: list: - 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. - 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 - 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 Also physical requirements: 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. Local travel may be required. We'll include these under Requirements. Now Benefits: list: 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. Pay: Compensation: $25 to $27 per hour (depending on experience). Schedule: Shift: Monday-Friday day shift (40 hours per week). Location: Onsite, Walnut Creek, CA. FLSA Classification: Non-Exempt. We could include location and FLSA under Schedule or About the role. But we already put location and shift in About the role. To avoid duplication, maybe we move location and shift to Schedule section, and keep About the role more generic. Let's restructure: About the role: brief description of role purpose (maybe from PURPOSE). Could be: "We are actively hiring a Regulatory Specialist to support our Walnut Creek, CA site." but that includes location. Might be okay. But we need to avoid duplication. Let's decide: - About the role: short paragraph describing the role and its purpose (from PURPOSE). Not include location/shift/pay. - Responsibilities: list of essential job functions. - Requirements: education, experience, knowledge/skills, physical requirements. - Benefits: list. - Pay: compensation. - Schedule: shift, location, FLSA. Thus we avoid repeating location/shift/pay in About the role. Now we need to ensure we preserve all substantive information: we must not lose any details like "FLSA Classification: Non-Exempt", "Location: Onsite, Walnut Creek, CA", "Shift: Monday-Friday day shift (40 hours per week)", "Compensation: $25 to $27 per hour (depending on experience)". Also we must preserve the purpose description. Now we need to remove boilerplate: EEO statements, equal opportunity, accommodation, etc. Also remove "Flourish Research is an equal employment opportunity employer..." etc. Also remove "We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities." That's