Job Title: Manager, Phase II/III Research
Position OverviewThe Manager, Phase II/III Research is responsible for the management of the Phase II/III Research Team at West Cancer Center and Research Institute (WCCRI). This role oversees Clinical Research Coordinators (CRCs), supports patients enrolled on Phase II/III clinical trials, and provides leadership for projects involving academic partners. The Manager is responsible for ensuring the successful execution of clinical research studies, maintaining regulatory compliance, supporting investigator-initiated collaborations, and fostering a high-performing research team.
Key Responsibilities- Supervise Clinical Research Coordinators (CRCs) within the Phase II/III research program and oversee daily clinical trial activities
- Educate new Phase II/III clinical team members on research processes and WCCRI policies and procedures
- Assign projects and monitor team workloads to ensure efficient study execution
- Recruit subjects for clinical trials using a variety of recruitment methods
- Screen potential subjects for eligibility by reviewing medical history and current clinical findings
- Educate nursing staff regarding protocol therapy administration and expected side effects
- Educate patients on protocol therapies, medication schedules, expected side effects, and appropriate actions to take if side effects occur
- Provide education to clinic staff regarding clinical trial opportunities and protocol requirements
- Assist with audit preparation and facilitate sponsor and academic partner audits
- Protect the rights, safety, and welfare of research participants
- Obtain and maintain informed consent documentation throughout each study
- Review newly activated protocols, protocol amendments, notices, suspensions, and study terminations
- Maintain current knowledge of the Code of Federal Regulations
- Collaborate with physicians, physician nurses, chemotherapy nurses, radiology, medical records, scheduling, phlebotomy, laboratory, insurance, and pharmacy regarding research activities
- Manage relationships with academic partners to develop and maintain the research portfolio
- Collaborate with physician investigators and academic partners to develop study protocols, informed consent documents, electronic case report forms, and data capture portals
- Coordinate with research team members to develop study budgets and facilitate contractual agreements for academic projects
- Maintain professionalism while respecting the dignity and confidentiality of patients
- Comply with clinic safety policies and procedures
- Attend staff meetings and participate in team-oriented collaboration
- Interface internally with Site Data Services, Regulatory Affairs, and Contracts/Budgeting personnel
- Interface externally with research sites, sponsors, and Contract Research Organizations (CROs)
- Perform all other duties as assigned
QualificationsEducation & ExperienceRequired:- Bachelor's degree from an accredited four-year college or university with a minimum of three (3) years of related experience; OR five (5) to seven (7) years of related experience and/or training in a healthcare or clinical research environment; OR an equivalent combination of education and experience
- Excellent organizational and follow-up skills
- Excellent verbal and written communication skills
- Strong problem-solving skills with the ability to organize and prioritize work assignments
- Ability to manage multiple priorities in a fast-paced environment
- Ability to analyze situations and respond in a timely manner
- Ability to work effectively within multidisciplinary teams
- Ability to establish and maintain effective working relationships throughout West Cancer Center
- Proficiency in computer applications, including word processing and email
- Ability to read, analyze, and interpret financial reports, government regulations, scientific journals, technical documents, and legal documents
- Ability to communicate effectively both verbally and in writing with customers, regulatory agencies, and members of the business community
- Ability to effectively present information to leadership, employee groups, and public audiences
- Ability to calculate figures and amounts, including discounts, percentages, body surface area (BSA), absolute neutrophil count (ANC), drug calculations, area, circumference, and volume
- Ability to apply concepts of basic algebra and geometry
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to interpret complex technical instructions and manage multiple abstract and concrete variables
- Additional hours may be required
- Travel may be required
Preferred:- Clinical research certification through SoCRA or ACRP
Work Environment & Physical Demands- Ability to work near toxic or caustic chemicals
- Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, and use hands and wrists for extended periods of time
- Ability to communicate effectively verbally and in writing
- Ability to lift up to 10 pounds
No nights, weekends, or holidays. Comprehensive benefits package.Join UsIf you are an experienced clinical research professional with a passion for leadership, collaboration, and advancing oncology research, we encourage you to apply for the Manager, Phase II/III Research position at West Cancer Center.
