We are currently searching for a Clinical Operations Coordinator to perform a variety of research, data, regulatory and clerical duties of a routine and technical nature to support the conduct of Clinical Human Subjects Research under the direction of a senior research team member. This is a full-time, on-site opportunity in Baltimore, MD.

Duties include, but not limited to: 

• Assist researchers collect, organize, and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
• Develop clinical research informed consent and other ethics and regulatory related documentation.
• Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
• Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.
• Assist researchers prepare study reports and status updates, including amendments, audits, and other administrative documentation.
• Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports, and correspondence.
• Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
• Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
• Assist researchers prepare, review, and submit clinical data to monitoring agencies.
• Assist IRB administrator collect, review, and maintain all IRB records.
• Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals, and others.
• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
• Assist researchers coordinate recruitment, scheduling, travel, and admission of research study participants with clinical staff.
• Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems, and concerns to appropriate staff members.
• Develop standard operating procedures (SOPs) for the clinical study.
• Prepare study reports and status updates, including amendments, audits, and other administrative documentation.
• Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Maintain accurate records of all protocols and study applications, safety reports, annual reports, and correspondence.
• Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.
• Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Coordinate with IRB administrator to collect, review and maintain all IRB records.
• Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals, and others.
• Prepare researcher communication with IRB and NIH Clinical Center for protocol approval.
• Prepare submission documentation for regulatory bodies in support of clinical trials.
• Manage, track, and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: None 

Education: Bachelor's Degree in a scientific discipline 

Years’ experience: At least one (1) year of experience in a pre-clinical setting 

• The candidate should have training, experience, and/or certification in GCP documentation and/or IRB practices
• Excellent and proven oral and written scientific communication skills and must be proficient with technology and data base management
• Excellent inter-personal skills to effectively work with and train large groups of people and liaison with other departments within and outside the Institute
• Electronic Medical Records System experience
• Electronic Data Capture System experience

Certifications: 

• Must be an active membership to an accredited Clinical Research Organization is desirable, e.g., The Society of Clinical Research Associates (SOCRA), The Public Responsibility in Medicine and Research (PRIMR)
• Certified Clinical Research Professional (CCRP)

Additional Information:

Location: Baltimore, MD 

Travel: None 

Remote, Onsite, or Hybrid: Onsite (Telework eligible) 

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Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities