United States onlyAbout Us:
Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.
Title: TEMPORARY - Research Regulatory Coordinator I or II
Compensation: $35 - $40 per hour depending on experience and qualifications
Status: Full-time, 3-Month Contract (eligible for overtime)
Work Schedule: Monday-Friday, 7:00a - 4:00p (role aligned to Arizona hours)
Start date: June 2nd or June 9th
Location: Remote, US
Preference for candidates currently located in US states that we are currently set up to do business (Arizona, Texas, Florida, Ohio, Minnesota). This role is not open to hire in California or New York.
Essential job functions/duties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
- Ensures high integrity of data and patient safety at the research site through data coordination, document and regulatory management and regulatory compliance.
- Coordinates, assesses, plans, and facilitates Regulatory Affairs in the areas of training and compliance, system-wide use of GCP principals, and application of FDA and ICH guidelines.
- Implements and maintains study protocols from planning, through startup, lifecycle and closure.
- Coordinate Compliance Onboarding for new hires; this includes initial communication with new hires, collection and filing of compliance credentials, routing and tracking study trainings & delegations; collaboration with Compliance Engineer, Regulatory Staff and Research Managers
- Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports.
- Understands and coordinates with the Director of clinical research, compliance with regulations as they apply to multi-center clinical research studies.
- Assists research staff and PIs in initiating, follow-up, negotiating, and resolving issues regarding current and future submissions
- Interacts with the third-party monitors for regulatory compliance and responds to regulatory queries.
- Executes and maintains a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents.
- Reviews sponsor guidelines for each study to ensure compliance with SOP; suggest modifications as necessary for compatibility.
- Liaison with the IRB to resolve questions and/or concerns
- Maintain Delegation Logs
- Communicate with third parties
- Basic IRB Submissions
- Accurately file all regulatory documents
- Distinguish reportable protocol deviations
- Assist with monitoring visit
Knowledge/Skills/Abilities Required
- Knowledge of local, state and federal regulations that apply to human subject’s research, including FDA, ICH and GCP regulations, sponsor guidelines and all SOPs.
- Knowledge of protocol specific and IRB specific reporting guidelines for protocol deviations, serious adverse events and other reportable events.
- Basic knowledge of Study Protocols
Education, credentials, and/or trainings required:
- High School Diploma or GED required
- Regulatory experience, preferably in sponsor-led Clinical Research, preferred
Benefits & Perks:
- Accrued up to 40 hours of sick time per year
Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.
EEO statement
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.
Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.
