Job Description
Supervision Exercised:
Precision Oncology Research personnel involved in administrative tasks, including but not limited to Administrative Assistant.
General Summary:
The Research Administrator (RA) will assist the Research Operations Administrator (ROA) with oversight of the administrative and regulatory processes related to clinical trials from study start up to closeout, inclusive of Institutional Review Board (IRB) submissions, regulatory document preparation, completion, collection, and submission as well as Investigator Study File (ISF), Pharmacy, and Lab Binder Maintenance, and monitoring visit preparation and execution.
Additionally, the RA will support the Sr. Director, Research Site Operations and ROA in day to day operations of the program, including aspects related to Study Development, completion of feasibility surveys, and Principal Investigator (PI) Oversight meeting documentation.
Principal Duties & Responsibilities:
- Administrative: assists with the oversight and execution of the administrative and regulatory processes related to clinical trials from study start up to closeout, inclusive of Institutional Review Board (IRB) submissions, regulatory document preparation, completion and collection as well as Investigator Study File (ISF) Maintenance.
- Prepares clinical research documents submissions, including 1572 forms, Site Documents (CVs, Medical Licenses, Laboratory Certifications), Source Document Forms, Financial Exhibits, Site Contact Forms, Financial Disclosures, Delegation of Authority Logs, and other specified documents, to CROs/Pharmaceutical Companies.
- Prepares submissions of Initial Review, Continuing Review, and Modifications to the IRB.
- Prepares clinical trial Informed Consent Forms for submission to the IRB.
- Assesses safety reporting requirements for each study and prepares IND Safety Report overviews for the Principal Investigator’s oversight, as applicable.
- Works with the CROs/Pharmaceutical Companies throughout the study lifecycle to assist with document requests and study closeout including final IRB submissions and document storage/retention.
- Develops and maintains trial specific Investigator Site Files, Pharmacy binders, and Laboratory binders throughout study duration, ensuring that all files are maintained in accordance with CRO/Sponsor expectations.
- Develops and maintains essential document files and spreadsheets for all research staff members and laboratories.
- Prepares and disseminates important clinical trial related and program updates to the appropriate study staff in a timely manner.
- Develops and maintains TCRC program related spreadsheets and documents.
- Communicates with sponsor representatives to schedule monitoring visits and assists with monitoring visit preparation and serves as a site liaison during the visits.
- Tracks and submits patient reimbursements and stipends, as applicable per trial.
- Provides EMR access to sponsor representatives in accordance with site compliance requirements.
- Operational Support: supports the Sr. Director, Research Site Operations and ROA in day to day operations of the program, including aspects related to Study Development and completion of feasibility surveys and Principal Investigator (PI) Oversight meeting documentation.
- Assists in completing study feasibility surveys.
- Attends and documents weekly PI Oversight meeting discussion topics.
- Maintains administrative study logs and other spreadsheets, as applicable
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, and Investigators
- Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participate in their resolution.
- Maintains the confidentiality of information acquired pertaining to patient, physicians, employees, and visitors. Discusses patient and hospital information only among appropriate personnel.
- Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.
- Actively demonstrates the organization's mission and core values and conducts oneself at all times in a manner consistent with these values.
- Knows and adheres to all laws and regulations pertaining to patient health, safety and medical information.
Knowledge, Skills & Abilities:
Required:
- Minimum 5 years of administrative experience in research.
- Knowledge of GCP.
- Strong team-oriented, results driven and collaborative style.
- Certification in Human Subjects Protection, Good Clinical Practices (must be obtained within 30 days of hire).
- Strong organizational and communication skills.
Education:
- Bachelor’s degree and/or equivalent experience
Preferred:
- Master’s degree in a health-related field
- Early Phase Clinical Trial experience (Phase I / First In Human)
- Relevant Regulatory experience in Oncology clinical trials
