Overview

Job Summary

Conducts and develops all aspects of clinical, regulatory, business, and other research- related activities and documentation for clinical trials, following industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.

Essential Functions

• Fulfills the job responsibilities of the Oncology Research Coordinator, and:
• Assists Principal Investigator and team in evaluating feasibility of research studies.
• Develops study budget in collaboration with team.
• Coordinates documentation for regulatory requirements.
• Coordinates trial-related activity of patients on protocols.
• Serves as the key resource for Principal Investigator, physicians and research team and acts as the primary liaison with sponsors to facilitate study initiation, execution and termination.
• Ensures accurate and timely data collection, submission, and query resolution.
• Coordinates protocol-level documentation to ensure regulatory and institutional compliance and coordinates protocol activities.
• Educates patients and families about research studies, treatments, side effects and follow-up, as appropriate.
• Provides resources for staff and patients, family and community, regarding research.
• Seeks ways to reduce costs and improve efficiencies.
• Collaborates with investigators through attendance at Section meetings, conferences, and other meetings.
• Participates in protocol QA activities, monitoring visits, and audits.
• Trains staff in preparation and conduct of clinical trials.
• Serves as key resource for onboarding/training/education for new Clinical Trials Office (CTO) Teammates
• Primarily remote with some onsite days

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 3 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 2 years of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 6 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. Supervisory experience or experience leading teams preferred.