Manager, Phase II/III Research

Position Summary:  This position is responsible for the management of the Phase II/III Research Team at West Cancer Center and Research Institute (WCCRI). The Manager is responsible for subjects enrolled on phase II/III clinical trials and will oversee additional CRC’s within the Phase II/III group. This position will be responsible for the build out and oversight of projects with academic partners. Work is performed under the general direction of Director of Research Nursing.

Essential Duties and Responsibilities:

• Supervises CRC staff in the phase II/III program in the completion of daily procedures associated with clinical trials
• Educates new phase II/III clinical team members to research and WCCRI policies and procedures
• Assigns projects to phase II/III team and monitors workload of team members
• Recruit’s subjects for clinical trials through a variety of methods
• Screens potential subjects for eligibility to phase II/III clinical trials including a careful review of the patient’s past medical history and a review of current findings
• Educates staff nurses about proper administration and expected side effects of protocol therapy
• Educates patients about protocol therapy including when medications are to be taken, what side effects to look for and actions to take in event that side effects occur
• Provides education to clinic staff regarding trial opportunities and protocol requirements
• Assist with audit preparation and facilitation for sponsor/academic related projects
• Protects the rights, safety and welfare of the patients
• Obtains and maintains informed consents of each patient for the duration of a study
• Reviews newly-activated protocols, amendments, notices, suspensions and terminations
• Responsible for maintaining a current knowledge of the Code of Federal Regulations
• Interfaces with Physicians, Physician Nurses, Chemotherapy Nurses, Radiology, Medical Records, Front Desk/Scheduling, Phlebotomy, Laboratory, Insurance and Pharmacy regarding research
• Manage relationship with academic partners to build out and maintain research portfolio
• Work with physician investigators and academic partners to develop study related documents including protocols, patient informed consent documents, electronic case report forms and data capture portals
• Coordinate with other members of the research team to develop study budgets and facilitate contractual agreements for academic projects
• Maintains a professional approach respecting the dignity and confidentiality of patients
• Maintains a good attendance record and reports on time for work
• Maintains a professional attitude and appearance
• Complies with clinic safety policies and procedures
• Possesses good communication skills that lend to a team-oriented work environment
• Attends staff meetings as scheduled
• Interfaces internally with fellow Site Data Services staff, Regulatory Affairs, and Contracts/Budgeting personnel
• Interfaces externally with the site, sponsors, and CROs
• Performs all other duties as assigned

 Qualifications/Experience:

Bachelor’s degree from four-year college or university and three years related experience; OR five to seven years related experience and/or training in a healthcare or clinical research environment; OR equivalent combination of education and experience which enables one to perform the essential job functions.  Certification in clinical research from SoCRA or ACRP preferred.

Required Knowledge, Skills and Abilities

• Must have excellent organization and follow-up skills
• Must have excellent verbal and written communication skills
• Must have excellent problem-solving skills; ability to organize and prioritize work assignments
• Ability to handle multiple priorities in a fast-paced environment
• Ability to analyze situations and respond in a timely manner
• Ability to participate in multi-functional teams
• Ability to establish and maintain effective working relationships within the West Cancer Center
• Must be proficient in computer applications including word processing and email
• Ability to work near toxic or caustic chemicals
• Ability to read, analyze and interpret financial reports, government regulations, common scientific and technical journals and legal documents
• Ability to respond verbally and in writing to common inquiries or complaints from customers, regulatory agencies or members of the business community
• Ability to effectively present information to top management, large employee groups and/or public groups
• Ability to calculate figures and amounts such as discounts, interest, commissions, percentages, BSA, ANC, drug calculations, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Ability to define problems, collect data, establish facts, draw valid conclusions
• Ability to interpret an extensive variety of technical complex instructions and deal with several abstract and concrete variables
• Ability to sit, stand, walk, reach, climb or balance, stoop or crouch, hand/wrist use, talk, see and hear for extended periods of time
• Ability to lift up to 10 lbs.
• Additional hours may be required
• Travel may be required