Coordinator, Early Access Programs

Our Why

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to impact the lives of patients and caregivers every day. At Early Access Care, our mission is to facilitate investigational medicines to patients without treatment options.  If you come from a clinical research background, this job might be an ideal fit – immediate global impact for patients with serious and life-threatening conditions.  Our team lives our mission every day.  More information about our company can be found at www.earlyaccesscare.com

About the Role

Manages the operational activities for requests for compassionate use of investigational drugs from physicians and their staff around the world.  Manages essential document collection, including health authority importation authorization, Institutional Review Board (IRB) and Ethics Committee (IEC) approvals, institution contracts and other essential documents.  Collaborates with physician and site staff to conduct compassionate use using Good Clinical Practice (GCP) principles and ensuring accurate data, subject safety and impeccable documentation.

Principle Responsibilities

·            Be responsible for the management of compassionate use requests using our IT systems, tools, and expertise to ensure the physician and site staff meet all aspects of local regulatory requirements.

·            Be the first contact of the company with the customer (physician, MD), therefore establishes and maintains customer essential relationships.

·         Develop, lead, communicate and execute the Early Access (EA) and Compassionate Use (CU) plans to support EA programs.

·         Manage the receipt, assessment, and/or committee review of all requests for Requests (RIDS)

·         Communicate decisions to requesting physicians in a timely manner. If a request for EA is approved, manage/ support the supply chain, regulatory, drug safety, and legal execution of the request in a timely matter to ensure the patient receives the drug and that ongoing treatment is maintained uninterrupted.

·            Operational end to end management of requests for investigational drugs.

·            Provide adequate site (Physician and staff)  resources for conduct of the compassionate use request.

·            Provide proper training Physician and site staff on the compassionate use medication, preparation, storage, administration and safety oversight.

·            Provide proper control, storage, dispensation, and accountability of Investigational Product.

·            Ensure site enrollment information is up to date in our IT systems and tools.

·         Understanding of Clinical Research industry and the relevant environments in which it operates

·         Ability to plan activities and works well under changing circumstances.

·         Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of compassionate use.

·         Ensure all adverse events (AEs) are appropriately reported within the time periods required the protocol/treatment plan, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s);

·         Proactively identify potential issues and assist the project team in the development of site Corrective Action/Preventative Action Plans (CAPAs) if required,

·         Works to improve tools and processes within functional area.

·         Ability to work as part of a team.

Early Access Care LLC