Clinical Research Manager - Hematology and Oncology

• →Directs a program or research office.
• →Conducts research in area of expertise.
• →Collaborates with other researchers on long-range plans for research projects.
• →Oversees the development of research projects.
• →Ensures research projects progress according to plan.
• →Investigates, modifies and applies new procedures, techniques, or applications of technology.
• →Establishes goals and operating procedures, practices, and guidelines.
• →Establishes, monitors, and controls project budgets.
• →In collaboration with research faculty and personnel, participates as a skilled individual contributor and/or researcher.
• →Prepares grant/funding applications.
• →Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).
• →Oversees activities related to data collection and analysis.
• →Coordinates the conduct of the study from screening to completion, including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• →Protects patients and data confidentiality by ensuring security of research data and personal health information.
• →Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
• →Understands the IRB submission and review process, and when and how to apply for IRB review including facilitation of study initiation through meticulous and timely preparation of IRB submissions.
• →Understands the federal research regulations and identifies the federal research organizations’ role in regulating human research participation.
• →Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• →Supervises both researchers and research support staff.
• →Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
• →Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.
• →Performs other related work as needed.

• Research certification, such as Graham School Clinical Trials Management and Regulatory Compliance, SoCRA, ACRP.

• Master's degree.

• Supervisory skills.
• Background in a leadership role.

• Proficient in monitoring and auditing clinical research trials for compliance/billing accuracy, such as site monitoring, quality assurance, and creating monitoring plans.
• Working knowledge of managing research projects.
• Develop research program and work strategically with principal investigator(s).
• Lead robust operational and financial analysis of study(ies) and/or program performance.
• Read and understand clinical trials protocols.
• Knowledge of regulatory policies and procedures.
• Knowledge of grant and contract administration.
• Familiarity with medical and scientific terminology.
• Demonstrated knowledge of Good Clinical Practices (GCP).

• Develop a program and a team.
• Excellent time management skills and work independently.
• Strong analytical skills.
• Identify funding sources.

• Resume/CV (required)
• Cover Letter (required)

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FLSA Status

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Pay Range

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

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