The CRN takes ownership and responsibility for the day-to-day management of genomic research trials including but not limited to the MCGI and Tapur trials, through close out.
- Participates in the informed consent process of study subjects at all NL EMMC participating sites
- Supports the safety of clinical research patients/research participants
- Coordinates protocol related research procedures, study visits, and follow-up care with all participating sites
- Screens, recruits and enrolls research participants
- Maintains study source documents
- Reports adverse events
- Understands and is compliant with good clinical practice (GCP) and regulatory compliance with CITI training completion
- Educates staff at remote NL EMMC participating sites on protocol, study intervention, study drug, etc.
- Educates subjects and family on protocol, study intervention, study drug, etc.
- Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
- Works closely with clinical trials team to identify, implement and successfully conduct cooperative group, industry, and investigator-led clinical trials.
- Ensures financial, operational, accrual and other strategic targets are met. Develops and implements corrective action plans as necessary to improve productivity, quality and/or process workflows.
- Works closely with physicians and study teams at all participating sitesto ensure efficient and timely implementation of new genomic trials and ensures and maintains ongoing compliance with company policies and procedures, SOPs, ICH/GCP guidelines, and FDA regulations.
- Brings oncology research subject matter expertise to the planning and execution of study start-up processes, to include remote NL EMMC participating sites, including:
- — study feasibility,
- — Medicare Coverage Analysis development (SOC vs NSOC assessments) and study budget negotiations
- — Study startup operational efficiency and effectiveness
- Participates in the development of policies and procedures, and other tools to support the studies with the research manager
- May represent the interests of the oncology research program at local/national meetings and educational conferences pertinent to public relations and future business development.
Qualifications and Skills:
- Exceptional organizational and clinical research management skills
- Excellent interpersonal skills with the ability to build strong relationships across multiple organizations
- Excellent time management, critical thinking, analytical and problem-solving skills
- Advanced computer skills, including CTMS, EDC, document management systems, databases and Microsoft Office suite
Experience and Education:
- BS degree in life sciences or related research field required (advanced degrees preferred)
- RN required, with current OCN or CRA/CRC certification preferred (ACRP or SoCRA)
- 3+ years of oncology research experience