Oncology Research Consultant RN/Investigator-Initiated Research Development Project Manager

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.

Additional Essential Functions

• Acting on behalf of the Sponsor for Levine Cancer Institute (LCI) Investigator-Initiated Research (IIR) clinical trials, facilitates the completion of project development in collaboration with the Sponsor Investigator, Biostatistics, QA Monitoring, Pharmacy, Regulatory, Clinical and Data Project Management, Finance, Contracts, external funding entities and other key sponsor stakeholders
• Assists in editing sections of LCI IIR clinical trial protocols after first draft is completed
• Writes informed consent forms for LCI IIR research clinical trials protocols
• Writes laboratory manuals for LCI IIR clinical trial protocols, in collaboration with Translational Research
• Manages questionnaires/surveys (creation and/or obtaining permissions, translation, etc) for use in LCI IIR clinical trial projects
• Facilitates protocol development meetings
• Serves as the key project contact for external funding entities during the development phase
• Coordinates stakeholder review of external funder/vendor contract drafts in collaboration with Contracts
• Coordinates and facilitates Site Initiation Visit training for IRB-approved LCI IIR clinical trial projects
• Collaborates with Regulatory team on IRB/FDA submissions and review
• Ensures relevant IIR project management development communication is maintained in the regulatory binder
• Facilitates LCI IIR clinical trial protocol amendments in collaboration with key stakeholders
• Assists in the development, improvement and review of Standard Operating Procedures and processes.
• Provides educational and technical assistance to new IIR teammates including orientation and mentoring of new IIR teammates.
• Collaborates with Sponsor-Investigators, Biostatistics, QA Monitoring and IIR Data Project Management to create data elements to inform protocol-specific endpoints
• Develops and updates protocol-specific eCRF Guidelines in collaboration with IIR Data Project Management
• Builds, tests, and upgrades protocol-specific databases
• Creates and leads protocol-specific database training
• Critically reviews protocol amendments in collaboration with IIR Data Project Management to determine whether actions are required for the database and/or eCRF Guidelines
• Troubleshoots end-user data entry issues and considers requests for eCRF updates in collaboration with IIR Data Project Management to determine the best course of action

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.

Additional Training and Certifications

• Experience in data entry, data management, and/or eCRF creation preferred. OnCore and REDCap experience a plus.
• Ability to review and understand all aspects of a clinical trial
• Clinical experience in Oncology preferred

• 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

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.