Regulatory Affairs Coordinator

Description
The Regulatory Affairs Specialist will have contact with the FDA, Pharmaceutical companies, Contract Research Organizations (CROs), Institutional Review Boards, community organizations, and 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.
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
Additional Skills & Qualifications
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
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Are Embedded Into Our Culture Through

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.