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Overview Job Summary Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.
Essential Functions
- Fulfills the job responsibilities of the Oncology Research Specialist, and:
- Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information.
- Assesses patient eligibility through chart reviews and patient/family interviews.
- Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial.
- Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
- Presents and obtains patient informed consent.
- Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data.
- Coordinates and prepares for internal and external audits.
- Participates in sponsor study start-up and follow-up meetings as appropriate.
- Develops study calendars.
- Collaborates on billing and financial activity with Research Finance (budgets and billing compliance).
- Coordinates scheduling of patient visits, labs, and diagnostic procedures.
- Coordinates drug shipments, storage, and accountability with IDS/Pharmacy.
- Assists in the development, improvement and review of Standard Operating Procedures and processes.
- Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.
Additional Essential Functions
- Working on behalf of the sponsor, collaborates with the Principal Investigator, Investigator-Initiated Research (IIR) Project Managers, Oncology Scientific Writers, and other sponsor-level stakeholders on the development and oversight of IIR consent-based studies
- Performs sponsor-level data management activities, including quality control and data entry compliance and metrics
- Collaborates with data project managers in development, testing, and validating research databases
- Provides input in collaboration with other sponsor stakeholders on annual reports as required by the AHWFBCCC Data Safety Monitoring Committee (DSMC)
- Provides data entry guidance to study conduct sites, utilizing available tools, and assists with technical problem solving
- Assists with issuing data queries and ensuring resolution in preparation for various reports and deadlines, to include but not limited to FDA annual reports, DSMC reports, funding company reports, abstracts/publications, and database lock
- Reviews and contributes to IIR project documents in development and amendments
- Development of reports and data tables in support of sponsor-led project oversight meetings
- Coordinates and leads applicable sponsor-led meetings with key stakeholders
- Prepares agendas and minutes for AHWFBCCC-sponsored study team meetings
- Facilitates and/or reviews amendments to AHWFBCCC-sponsored studies
- Ensures contractual requirements with external collaborators are met; writes and sends progress reports on AHWFBCCC-sponsored studies per funder requirements
- Creates and conducts Site Initiation Visit and amendment training for study conduct sites, including protocol, data and/or clinical operations
Physical Requirements
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
Education, Experience and Certifications Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Additional Training and Certifications
- Study conduct and data entry experience in oncology clinical trials strongly preferred
- Ability to review and understand all aspects of an oncology clinical trial
- Experience in serious adverse event reporting
- Collaborative attitude, with excellent verbal and written communication skills
- Organized, with ability to follow through, track, and follow-up on numerous ongoing initiatives
- Self-motivated and deadline-oriented, able to multi-task and function autonomously
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Atrium Health
Nov 23, 2024