Site Lead Clinical Research Coordinator (Infectious Disease Clinical Research Program)

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Updated: July 16, 2018
Job ID: 214077
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking a Site Lead Clinical Research Coordinator who will be responsible for Infectious Disease Clinical Research Program (IDCRP) site protocol operations and quality management, institutional liaison, regulatory compliance, personnel supervision, resource coordination, operations logistics, and communications/reporting at the local (fill in site location) and IDCRP network level.  Serves as the senior site clinical research coordinator. Serves as the representative for IDCRP for the site.  


Clinical Research Coordinator: Serves as backup clinical research coordinator to support protocol execution. As delegated by the protocol Principal Investigator(s) and IDCRP Chief CRM (or delegate), Site Protocol Operations Coordinator is responsible for managing the successful planning, development, implementation, and execution of clinical research protocols at the site. Oversees and assists with protocols at the site including accomplishment of milestones, identifying and managing challenges, and managing and coordinating resources including personnel time to accomplish the protocols. Responsible for protocol quality assurance activities, identifying and remediating issues. Ensures Human Subjects Protection training for staff, and is responsible for maintaining employee competency files (as directed by stakeholders). Oversees regulatory oversight (IRB) submissions and necessary agreements, Manages Regulatory Audits by Federal authorities, in collaboration with Principle Investigator. Oversees and manages privacy and confidentially standards per legal requirements for the site.  Complies, analyzes and submits enrollment-related performance metrics reports to stakeholders.

Personnel Management: Supervises IDCRP site staff to ensure understanding of expectations, performance of duties, accomplishment of tasks, and development of capabilities. Assesses personnel performance. Ensures proper time keeping and compliance with HJF policies and procedures including but not limited to site personnel travel, time reporting, personnel leave, coordination and recommendation of promotions and awards, personnel appraisals, personnel improvement plans. Consults with Clinical Research Manager(s) for recommendation on FTE percentage distribution across protocols.  Recommends hiring needs to senior leadership and assists in the hiring process. Develops junior staff.

Resource Management: Responsible for the budget execution of all protocol and protocol-support financial accounts, including training, travel and petty cash accounts, assigned to your site by senior leadership. Formulates draft protocol and protocol-support budgets. Contributes to site-related budgets with protocol team during concept phase.

Administrative Tasks: Develops site specific Standard Operating Procedures. Executes purchase agreements. Knowledge of contracts, operational and financial agreements. Oversees the safety and resources for site personnel to complete required duties. Develops reports and presentations on site activities. Maintains documentation of all necessary training requirements.

Onboarding of Site Staff: Ensures adherence of site onboarding procedures including CAC issuance, security clearances, program and site training requirements and credentialing of staff.

Performs other duties as assigned.

Required Knowledge, Skills, and Abilities:   Knowledge of federal and local regulations and policies pertinent to research involving human subjects; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels

Minimum Education/Training Requirements:  Bachelor's degree in a scientific discipline required; Master’s degree in a related area is preferred.

Minimum Experience: 5 years’ experience managing multiple clinical research protocols and personnel in a supervisory capacity.

Physical Capabilities: Long periods of sitting and standing; some bending, lifting, and walking; escorting patients and carrying light items; may encounter patients who are confused, agitated, or abusive

Required Licenses, Certification or Registration: Certified in basic cardiac life support. Good Clinical Practice and/or human subject protections training.  Certified as a Clinical Research Coordinator (CCRC), and/or Clinical Research Professional (CCRP) preferred.

Work Environment:  Laboratory, office or clinical/hospital environment; possible evening and/or weekend hours.

Background: US Citizenship required; eligibility to obtain and hold Department of Defense Secret Clearance and Common Access Card (CAC).

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.