Job Description

Functions independently in a clinical research setting and responsible for the complete coordination of a multi-site clinical trial. Partners with the Principal Investigators to develop and implement strategies to efficiently complete study. Capable of assisting with all clinical research coordinator responsibilities as detailed in the CRC job responsibilities but primary role is focused more on managing the execution of a trial across multiple sites.

Orients and trains staff handling research administration activities associated with the trial, including developing and administering training materials, standard operating procedures, and manual of study operations. Monitors service levels and identifies adequate coverage for trial and study workload across multiple studies.

Job Responsibilities

• Assist study PI to finalize study protocol, develop manual of operations and training materials
• Supervise the implementation of and adherence to study protocols. Educate research and clinical staff on established policies, processes, and
• Oversee monitoring activities (both onsite and remotely) as needed to verify data quality and provide site study training
• Coordinate regular study teleconferences among study sites
• Manage study timelines
• Determine effective strategies for promoting/recruiting research participants and retaining trial participants.
• Help to develop charter for Data Safety and Monitoring Board (DSMB), coordinate DSMB meetings, request disclosures of all potential COIs for the DSMB members, record the information, and ensure that it has been discussed and verified to not exclude any member from participation on the DSMB,
• Assist in developing consent forms for approval by Human Subjects
• Establish and complete a risk assessment document and creates a plan to mitigate risks identified
• Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple
• Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Monitor Institutional Review Board submissions, and respond to requests and
• Work with the Clinical Data Manager to assure high-quality data submission
• Provide leadership and expertise in identifying and completing research
• Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and
• Provide guidance and support for clinical research coordinators who are assigned to project specific protocols and who will help with the overall clinical research of the study
• May have supervisory

Management Group

• Lead or chair committees or task forces to address and resolve significant
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external
• Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician
• Assist with analysis of data and preparation of manuscripts and scientific presentations.

Required Education and Experience

Required Education: Bachelor’s degree

Required Experience: Three (3) years relevant clinical research experience

Preferred Education: Master’s degree

Additional Technical Requirements

• Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB
• Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 60,000 - 80,000.

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