Coordinator- Oncology Research/Clinical Project Coordinator- Investigator Initiated Research
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Charlotte, NC, United States
Job ID: 29871
Job Family: Research Services
Status: Full Time
Shift Details: Regular
Department Name: 11011036640304-Clinical Trials - LCI
Location: LCI - 1021 Morehead Medical Dr
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.
Additional Essential Functions
- Working on behalf of the sponsor, collaborates with the Levine Cancer Institute (LCI) Investigator-Initiated Research (IIR) Clinical Project Manager and other sponsor-level stakeholders to oversee study conduct on LCI-sponsored clinical trials
- Reviews LCI-sponsored clinical trials in development and amendments from a clinical operations perspective; participates in protocol and data element review meetings as applicable
- Coordinates and leads applicable sponsor-led meetings with key stakeholders
- Prepares agendas and minutes for LCI-sponsored study team meetings
- Reviews and assesses LCI sponsored protocol questions from study conduct sites and provides appropriate feedback
- Assists with/facilitates amendments to LCI-sponsored clinical trials
- Ensures contractual requirements with external collaborators are being met; writes and sends progress reports on LCI-sponsored clinical trials per funder requirements
- Facilitates completion of Data and Safety Monitoring Committee reports for LCI-sponsored clinical trials
- Reviews, queries, and reports all expedited safety event and deviation reports received from study conduct sites on LCI-sponsored clinical trials
- Creates and conducts applicable Site Initiation Visit and amendment training for study conduct sites
- 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.
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
- Clinical experience in Oncology preferred
- Ability to review and understand all aspects of a 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