Clinical Research Associate-Regulatory-Research-Oncology

Job Objective:

Responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators within the Health System. Key to this role is the preparation and maintenance of clinical trial protocols and related regulatory documents for submission to the Eisenhower Human Research Protections Program (Eisenhower Medical Center's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. Acts as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies and procedures concerning the conduct of clinical trials, including those of the FDA, OHRP, HHS, Eisenhower IRB, and the Research department. Specialties actively engaged in clinical research include Oncology, HIV, Infectious Disease, Gastroenterology, Cardiology, Orthopedics and Pulmonology.

Essential Responsibilities:

• Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
• Performs pre-investigation, initiation and routine monitoring to assure that the protocol, obligations, responsibilities, and regulations are established and followed.
• Monitors subject records for quality, data integrity, and compliance with regulations and organization’s standard operating procedures (SOPs).
• Prepares materials for Institutional Review Board (IRB) presentation; serves as a resource for the PI.
• Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the IRB, Food and Drug Administration (FDA) and sponsors.
• Shepherds protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned.
• Serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to sponsors, including the National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed.
• Creates training documents and documents staff training based on updates to research protocols.
• Distributes new protocol information to study team members.
• Updates model informed consent document from sponsor with local context (boilerplate) language.
• Maintains communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the IRB and FDA, and sponsor monitors.
• Maintains standard regulatory files (electronic and hard copy), including: Monitoring Log; Protocol and Amendments; Standard Operating Procedures (SOPs) to ensure consistent handling and processing among the study team members; Manual of Operations (MOO) or Manual of Operations and Procedures (MOOP/MOP); Investigator Brochure/Drug Insert/Device Manual; Source Documents and Case Report Forms; Delegation of Authority/Site Signature Log; Curriculum Vitae (CV)/Licensure; Conflict Of Interest (COI)/Financial Disclosure;
• Works occasional evenings and weekends as needed.

Essential Skils:

• Ability to create and maintain positive interpersonal relations with peers, staff, leaders and vendors
• Ability to maintain high degree of confidentiality
• Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge
• Ability to prioritize tasks and manage time efficiently to meet deadlines
• Ability to organize information or data to facilitate easy retrieval and use
• Ability to analyze issues, identify root causes, and develop solutions
• Written and verbal communication skills