Senior Research Associate (Clinical) - NIH

Global Solutions Network Inc•Bethesda, MD

9d•$78,000 - $148,500

About The Position

Global Solutions Network (GSN), a federal government contracting firm, is hiring a full-time, long-term Senior Research Associate to support its customer at the National Institutes of Health (NIH). The role supports clinical researchers with the preparation and management of clinical research proposals, protocols, ethics and regulatory documentation, submissions, and study records. It also involves participant coordination, data management, quality assurance, regulatory readiness, and guidance and training for research staff and investigators.

Requirements

Master's degree in a related field.
CITI certification.
Familiarity with Electronic Data Capture Systems.
Demonstrated experience liaising with regulatory authorities.
Demonstrated experience training clinical trial site staff.
Demonstrated experience coordinating project meetings.
Previous clinical trial work.

Responsibilities

Assist researchers with developing and preparing internal research proposals, abstract submissions, poster presentations, and manuscript drafts; review completed materials and recommend changes.
Develop and edit clinical study protocols, amendments, reviews, reports, forms, schemas, patient calendars, and teaching aids, and review documentation for accuracy and completeness.
Develop clinical research informed consent documents and other ethics- and regulatory-related documentation.
Develop standard operating procedures for clinical studies.
Prepare study reports and status updates, including amendments, audits, and other administrative documentation.
Prepare IND and IDE safety and clinical study reports and regulatory correspondence, including initial submissions, information requests, amendments, and annual reports.
Collect, organize, maintain, and review study documentation, including investigator qualifications, trial logs, safety reports, and complete, up-to-date regulatory binders.
Maintain and review records of protocols, study applications, safety reports, annual reports, and correspondence.
Maintain data files in multiple software systems, including computerized procurement reports and communication programs.
Enter and clean questionnaire data in databases and conduct queries to answer researcher questions.
Track study requests, protocol submissions, and approval status.
Coordinate with the IRB administrator to collect, review, and maintain IRB records.
Review and submit protocol actions for clearance through the NIH Protocol Tracking and Management System.
Conduct quality assurance activities and prepare for regulatory audits by the FDA, NIH, pharmaceutical companies, and other bodies.
Communicate with the IRB and NIH Clinical Center regarding protocol approval and prepare and submit documentation to regulatory bodies in support of clinical trials.
Assist with onsite and offsite patient scheduling, processes, and form preparation.
Coordinate participant recruitment, scheduling, travel, and admission with clinical staff; screen participants and document screening results.
Coordinate education and guidance for new staff on research activities, procedures, and standards, and maintain documentation of clinical research training.
Educate research staff on regulatory processes and requirements, including protocol development and trial conduct, regulatory changes, IRB and FDA submissions, radiation safety, ethics clearances, and technology transfer.
Train investigators on new protocol management systems and help maintain an efficient IRB submission process.
Meet with investigators and advise them on the documentation and approvals needed to initiate clinical studies based on the proposal's type, location, and complexity.