1) 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.
2) 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.
3) Provide day to day project oversight and management to the Clinical Research Coordinators and Data Managers on the team.
4) Responsible for the direction of a program or research office.
5) Conducts research in area of expertise.
6) Collaborates with other researchers on long-range plans for research projects.
7) Oversees the development of research projects.
8) Ensures research projects progress according to plan.
9) Investigates, modifies and applies new procedures, techniques or applications of technology.
10) Establishes goals and operating procedures, practices, and guidelines.
11) Establishes, monitors, and controls project budgets.
12) In collaboration with senior research faculty and personnel, participates as skilled individual contributor and/or lead researcher as expert in specialized area.
13) Prepares grant/funding applications.
14) Manages financial, personnel, planning, compliance and other administrative aspects of research project(s).
15) Oversees activities related to data collection and analysis.
16) 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.
17) Protect patients and data confidentiality by ensuring security of research data and personal health information.
18) Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
19) 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.
20) Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation.
21) 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.
22) Supervises both researchers and research support staff.
1) Ability to develop a program and a team.
2) Excellent time management skills and ability to work independently.
3) Ability to develop research program and work strategically with Principal Investigator(s).
4) Ability to lead robust operational and financial analysis of study(ies) and/or program performance.
5) Ability to read and understand clinical trials protocols.
6) Knowledge of regulatory policies and procedures.
7) Strong analytical skills.
8) Knowledge of grant and contract administration.
9) Familiarity with medical and scientific terminology.
10) Demonstrated knowledge of Good Clinical Practices (GCP).
11) Ability to identify funding sources.
1) Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, create monitoring plans)
2) Supervisory skills
3) Experience managing research projects
4) Experience in a leadership role
5) Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP)
2) Cover letter
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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