Clinical Protocol Coordinator

Provide support services to satisfy the overall operational objectives of the National Institute on Aging. The primary objective is to provide services and deliverables through performance of support services.

• Work products and documents related to scheduling meetings; serve as central point of contact for NIA clinical research protocol activity; organize/coordinate quality assurance activities; facilitate communication with IRB and NIH Clinical Center. - Daily

• Work products and documents related to coordinating amendments, annual reviews, triennial reviews, terminations, adverse events and other IRB interactions, coordinate IND submissions and annual renewals. - Daily

• Work products and documents related to coordinating protocol-specific documentation, such as schemas, patient calendar, teaching aids; coordinate/schedule protocol initiation meeting; facilitate protocol updates, amendments and other documents for IRB approval. - Daily

• Work products and documents related to documentation of clinical research training, coordinate education and guidance regarding research activities, procedures and standards for new staff members. - Daily

• Regular meetings (weekly to twice weekly) to present updates with protocol office staff. - Weekly

• Interact with NIA Principal Investigators and IRB staff to coordinate amendments, annual reviews, triennial reviews, terminations, adverse events and other IRB interactions. - 1
• Facilitate communication with IRB and NIH Clinical Center for protocol approval. - 2

• Schedule monthly NIA Clinical Investigators’ and Scientific Review Committee meetings. - 5

• Coordinate activities regarding Investigational New Drug (IND) submissions and annual renewals.

• Coordinate protocol-specific documentation, such as schemas, patient calendar, teaching aids, if applicable, and other activities through Study Manager TM software to provide protocol schedules at the start of a new study.

• Coordinate/schedule protocol initiation meeting with appropriate staff.

• Facilitate protocol updates, amendments and other documents as needed to obtain IRB approval.

• Maintain documentation of clinical research training (by OHRP, the Clinical Center and others) of clinical researchers as required by the IRB, NIH and others.

• Coordinate education and guidance regarding research activities, procedures and standards for new staff members as needed and as directed by the NIA Project Officer.

• Develop and maintain knowledge of and performance of job functions in compliance with all applicable rules, regulations, policies and statutes.

• Assists researchers with protocol development, assembly and review of clinical trial documents.

• Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.

• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.

• Assists researchers develop and maintain trial related documents and operational procedures.

• Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.

• Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.

• Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.

• Maintains study databases and conducts basic analysis.

• Maintain data files within multiple software systems, including computerized procurement reports and communication programs.

• Perform entry and cleanup of study of the questionnaire data in various databases and conduct queries to answer researcher questions.

• Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.

• Assist researchers prepare, review and submit clinical data to monitoring agencies.

• Assists researchers collect, distribute and file regulatory documents.

• 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 and communicate with IRB and NIH Clinical Center for protocol approval.

• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.

• Provides technical support to researchers and the clinic.

• Assist researchers with navigating NIH Protocol Tracking and Management System.

• Develops and maintains trial related documents and operational procedures.

• Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.

• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.

• 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.

• Collects and distributes regulatory documents.

• 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.

Certifications & Licenses

• Bachelor's degree with 1 year of related experience

• Certified Clinical Research Professional (CCRP)

Field of Study

• General Business

• Business Management and Administration

• Health and Medical Administrative Services

Software

• MS Office Suite

• PROTECT

Skills

• Strong communications skills, both oral and written

• Liaising with regulatory authorities

• Coordinating project meetings

• Liaise with ethics committee

• Regulatory compliance

• Protocol navigation

• IRB submissions

• Scheduling

• SOPs

• Excellent organizational, interpersonal and time management skills

• Familiarity with IRB requirements

• Knowledge of clinical protocols and medical terminology

• Upon start must complete within 30 days upon arrival at NIH the required NIH safety and research integrity coursework/training as mandated for all scientific staff working in NIH facilities which include: Introduction to Responsible Conduct of Research; Introduction to Laboratory Safety; Laboratory Safety at NIH; Protection of Human Research Subjects; Technology Transfer Online Training

• Must sign Patent Agreement form and Contractor Employee Patent Agreement form at vendor's orientation

• Upon employment must complete the NIA IRP New Employee Safety Training Checklist form and send the completed Checklist form to NIA Safety Officer; Tasks listed on the Safety Training Checklist must be completed within one week upon arrival at NIH

• Upon employment must complete required on-line training within 30 days upon arrival at NIH: Which include: NIH Computer Security Awareness Training; NIH Sexual Harassment Training; Disability Awareness Training

• Must complete required annual or bi-annual on-line training, per NIH guidelines, which include NIH Computer Security Awareness Training; NIH Sexual Harassment Training; Disability Awareness Training

• Protocol review revision

• Patient confidentiality