Regulatory Affairs Specialist

Context: Sunstone Therapies is the leader in the delivery of psychedelic-assisted therapy in the medical setting, focusing on the development and implementation of clinical trials today, and moving towards clinical delivery if and when therapies are approved. Sunstone Therapies is working to accelerate the on-the-ground learning and operations necessary to approve and scale psychedelic therapies in the medical setting. In service to Sunstone’s vision of Whole Person Healing for All, this position plays a role in Sunstone’s ability to deliver on its vision with Love and Rigor.

To be successful in this role in this growth stage start-up, the candidate must be a detail-oriented self-starter and problem solver, be able to shift projects and priorities rapidly to meet emerging needs and approach the work with the values of love and rigor, which are essential to the Sunstone culture.  

Scope: The Regulatory Affairs Specialist will have contact with the FDA, Pharmaceutical companies, Contract Research Organizations (CROs), Institutional Review Boards, community organizations, and Sunstone staff. Under direct supervision and guidance of the Research Manager, the Specialist is responsible for the planning, execution, and successful management of regulatory affairs, quality oversight, and data management pertaining to all clinical research activities. The Regulatory Affairs Specialist is responsible for project deliverables including planning, developing,  and maintaining various research projects, performing data collection, establishing and maintaining collaborative relationships with administration and peers, overseeing regulatory affairs, and meeting coordination.

Job activities include but are not limited to:

• Lead with project management duties, i.e., EHR integration, ISF management integration, IIT trials.
• Assist with design, and maintain centralized regulatory intelligence database that facilitates the management of all active, preparatory and archived clinical study regulatory and quality related activities
• Manage and evaluate company-wide ICH-GCP Standard Operating Procedures (SOPs)/ and associated quality and and data processes 
• Responsible for the development of processes into systems, training, managing, and evaluating systems associated with regulatory affairs, quality oversight, and data management
• Assist with the development, management, and evaluation of systems associated with regulatory affairs, quality oversight and data management
• Conduct ongoing research and analysis on current federal, state and local laws/regulations pertaining to Sunstone operations 
• Develop quality control measures, including  ongoing internal quality review of processes related to regulatory compliance and data integrity
• Collect, file and enter data in multiple platforms including sponsor edc systems and Sunstones EHR
• Prepare and submit start-up regulatory packets to Sponsor and IRB.
• Assist with study start-up activities to include reporting and communicating with Sponsor, IRB, and individual sites.
• Serve as a liaison to Sponsors/CRO/IRB/Investigators ensuring continuity of service and problem resolution.
• Monitor approval status of open studies by completing timely reviews.
• Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits.
• Serve as the CTMS administrator
• Responsible for oversight meeting management including collection of QC data and ownership of CRC completion of study data for oversight meeting
• Other duties as assigned.

To be successful in the role the incumbent must have:

• BS in related field/ comparable experience is required
• 2 years clinical trial research experience in regulatory and quality assurance is required
• A high level of computer/ software proficiency 
• Meticulous attention for detail and strong organizational skills
• Interpersonal skills, the ability to communicate complex data in a clear way, in both written and verbal communication
• Ability to demonstrate knowledge and skill in techniques of regulatory affairs and good clinical judgment
• A team player attitude
• Ability to prioritize projects and meet deadlines

Physical Requirements 

Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Required to stand, walk, and sit; talk or hear, both in person and by telephone; use hands to finger, handle, or feel objects or controls; reach with hands and arms.

Compensation and Benefits

Sunstone Therapies offers a competitive salary package commensurate with skills and experience plus benefits that include medical, dental, and vision coverage, and a retirement savings 401(k) plan.