Clinical Research Manager

Network Clinical Research Manager

The Network Clinical Research Manager (Manager) is a specialized research professional who is responsible for the direction of a program or a research office. The Manager works closely with the Director of Network Research Operations on long-range plans for network sites. While the Principal Investigator (PI) is primarily responsible for the overall design and conduct of the clinical trials in the network, the Manager collaborates with the PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as an expert.

The Manager ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities. The Manager may write articles, reports and manuscripts and/or present research findings at meetings/conferences. By performing these duties, the Manager works with the PI, department, sponsor, and institution to provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

Responsibilities

Research Conduct/Study Management:

• Responsible for the direction of a program or research office.
• Conducts research in the 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 technological applications.
• Establishes goals and operating procedures, practices, and guidelines.
• Establishes, monitors, and controls project budgets.
• In collaboration with senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as an expert in a specialized area.
• Prepares grant/funding applications.
• Manages financial, personnel, planning, compliance, and other administrative aspects of research project(s).

Data Management:

• Oversees activities related to data collection and analysis.
• Coordinates 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.
• Protects patient and data confidentiality by ensuring the security of research data and personal health information.

Regulatory:

• 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.
• Writes articles, reports, and manuscripts and presents research findings at meetings and/or 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.
• Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.
• Performs other related work as needed.

Minimum Qualifications

Education:

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.

Certifications:

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Preferred Qualifications

Experience:

• Supervisory skills strongly preferred.
• Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, creating monitoring plans) strongly preferred.
• Experience managing research projects strongly preferred.
• Experience in a leadership role strongly preferred.

Licenses and

Certifications:

• Research certification (e.g., Graham School Clinical Trials Management & Regulatory Compliance, SoCRA, ACRP) strongly preferred.

Preferred Competencies

• Ability to develop a program and a team.
• Excellent…