BSD MED - Section Administrator: Hematology and Oncology - Clinical Research Staff
About the Department
The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.
The Clinical Research Manager will provide project management, data management and clinical monitoring support for multiple types of trials (sponsored, grant funded, multi-site, and/or investigator-initiated trials in the Section of Hematology/Oncology in the Department of Medicine. The Clinical Research Manager will act as a liaison between clinical sites, the Clinical Trials Office and sponsors/agencies to ensure that clinical trials are conducted in compliance with the protocol and applicable institutional and regulatory guidelines. Provide day to day project oversight and management to the Clinical Research Coordinators and Data Managers on the team.
Research Conduct/Study Management
Responsible for the direction of a program or research office.
Conduct research in area of expertise.
Collaborate with other researchers on long-range plans for research projects.
Oversee the development of research projects.
Ensure research projects progress according to plan.
Investigate, modify and apply new procedures, techniques or applications of technology.
Establish goals and operating procedures, practices, and guidelines.
Establish, monitor, and control project budgets.
In collaboration with research faculty and personnel, participate as skilled individual contributor and/or researcher.
Prepare grant/funding applications.
Manage financial, personnel, planning, compliance and other administrative aspects of research project(s).
Oversee activities related to data collection and analysis.
Coordinate the conduct of the study from screening through to completion including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
Protect patients and data confidentiality by ensuring security of research data and personal health information.
Ensure compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Understand 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.
Understand the federal research regulations and identify the federal research organizations' role in regulating human research participation.
Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
Supervise 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.
Minimum requirements include a college or university degree in related field.
--- Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
Proficient monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans).
Working knowledge managing research projects.
Background in a leadership role.
Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP).
Develop a program and a team.
Excellent time management skills and ability to work independently.
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.
Strong analytical skills.
Knowledge of grant and contract administration.
Familiarity with medical and scientific terminology.
Demonstrated knowledge of Good Clinical Practices (GCP).
Identify funding sources.
Cover Letter (required)
When applying, the document(s) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.
Scheduled Weekly Hours
COVID-19 Vaccination or Approved Medical or Religious Exemption Required
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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