Clin Research Reg Spt Spec II

Responsibilities

• Coordinates and oversees regulatory requirements of clinical research protocols.
• Develops learned skills and assumes responsibility for a portfolio of clinical research protocols under the direction of the PI and senior leaders.
• Prepares all regulatory documentation, document filing, tracking, and maintenance.
• Documents new study in tracking system and maintains all logs, including OnCore, according to SOPs.
• Collates essential regulatory documents within Complion and prepares/drafts ICF and insert institutional language.
• Enters and loads all required documents to OnCore and Complion.
• Collaborates with DWG clinical research staff to validate the delegation log.
• Prepares and tracks submissions to IRB (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc.
• Maintains regulatory records and necessary correspondence records.
• Sets up and tracks submissions to IRB and sponsors for approval.
• Prepares and submits protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions.
• Assists with coordinating center functions and on-site and other site participation in clinical trials.
• Coordinates official internal activation and informs study coordinators and physicians about re-consents.
• Liaises with sponsors regarding activation requirements and timelines.
• Liaises with other required stakeholders and committees, such as HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc.
• Assists Clinical Research Coordinators and investigators with study document management and tracking.
• Ensures compliance with Good Clinical Practice and the Code of Federal Regulations.
• Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Assists in helping others in same and participates in protocol-related training as required.

Requirements

• Bachelor's degree and 1 year of relevant experience required.
• Equivalent combination of education and experience may be considered.

Qualifications

• Fully adheres to applicable safety and/or infection control standards.
• Understands and follows data integrity standards and processes.
• Ability to effectively manage a higher volume of protocols preferred.
• Ability to effectively manage moderately complex research protocols/procedures preferred.
• High degree of self-motivation.
• Recognized ability to function independently.
• Proficient in managing multiple and competing priorities/demands.
• Detailed-oriented in record keeping and research documentation.
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation.
• Strong interpersonal, communication, and organizational skills.
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients).
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet.