The Clinical Research Associate/Clinical Trial Monitor will be located at Fort Detrick in Frederick, Maryland in support of a contract with the Office of Regulated Activities (ORA) under the U.S. Army Medical Research and Development Command (USAMRDC). Though this position is primarily located at the government offices at Fort Detrick, there may be a possibility of remote work due to COVID-19.
ORA is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing medical products for the Warfighter. ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.
DUTIES AND RESPONSIBILITIES
- Provide oversight and develop monitoring and reporting procedures, methods, guidelines and tools to efficiently and effectively monitor the clinical trial process; support Principal Investigators (PIs) in the conduct of research in accordance with Institutional Review Board (IRB)-approved protocols.
- Verify and ensure the rights and well-being of the human subjects enrolled in the clinical trials are protected and the reported trial data are accurate, complete, and verifiable from source documents.
- Ensure the conduct of the trial is in compliance with protocols, current Good Clinical Practices (GCP), Food and Drug Administration (FDA) Title 21 of the Code of Federal Regulations (CFR), and Department of Defense (DoD) regulations, along with other applicable Sponsor and regulatory requirements, requirements of host countries and other government regulations.
- Develop Clinical Monitoring Plans for full support and oversight monitoring of single-site and multi-center clinical studies both inside and outside the continental United States.
- Conduct centralized monitoring activities to include remote review of electronic source documents, electronic Case Report Forms (eCRFs), investigator and site qualifications assessment, protocol training, investigational product management oversight, conducting remote meetings with site staff, evaluation of trends, and metrics in order to identify and mitigate safety and data quality risk issues.
- Prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities.
- Assist in the development, coordination, and implementation of monitoring and administrative strategies essential to the successful management of clinical trials research.
- Conduct site pre-qualification and initiation visits; verifying the suitability and adequacy of the facility for the conduct of the study. Verify that the assigned research staff have adequate qualifications and resources.
- Conduct on-site clinical monitoring that includes protocol training, document review, accurate data recording, verify patient data, ensuring adherence to the clinical protocol, site and Sponsor Standard Operating Procedures (SOPs), investigational product accountability, verification of product shipping/storage conditions, etc.
- Monitor adverse events, concomitant medications, and inter-current illnesses and verify they are reported in accordance with the protocol on the CRF.
- Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report.
- Include protocol deviations, violations and non-compliance information in monitoring reports.
- Provide remote evaluation of the study data, carried out by a team that may include: monitors, and medical reviewers and annotate in monitoring reports for the sponsor’s regulatory file.
- Provide oversight monitoring of contracted monitors for studies where this responsibility has been delegated by the sponsor.
- Prepare/review calibration and maintenance records, which are records kept at the clinical site document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file.
- Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites.
- Prepare and/or review laboratory sample analysis reports.
- Work effectively as part of an Integrated Product Team (IPT) and assist in resolving site related issues quickly and effectively.
- Maintain effective communication via teleconferences, videoconferencing, email etc. as well as telephone communication with the clinical sites.
- Review and revise protocols, informed consent forms, and other study related documents to include the initial versions and amendments using the Electronic Document Management System (EDMS).
- Maintain expertise in regulations for applicable geographies and types of studies (Drugs, Biologics, Devices to include: IDE, non significant risk, feasibility, exempt, etc.). Serves as a resource related to medical devices / IVDs clinical trial regulations
EDUCATION, SKILLS AND EXPERIENCE REQUIRED
- Bachelor’s degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology or related field of study)
- Preferred – Current certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
- 2+ years of experience in clinical trial monitoring including Electronic Data Capture (EDC) studies; experience in quality assurance or site coordination.
- Current Good Clinical Practices (GCP) training.
- Working knowledge of U.S. Federal government regulations to include the Federal Policy for the Protection of Human Subjects (“The Common Rule”)regarding the conduct of human clinical research.
- Work requires concentration, periods of standing and walking on a regular basis; must work well under pressure, in often changing conditions and research workload.
- Ability to exercise independent judgment to determine appropriate action and priorities in the performance of duties outlined herein.
- Must be highly organized, detail oriented, and perform independently.
- Excellent written and oral communication skills.
- Must be U.S. citizen and be able to obtain a TI (Public Trust).
- Proficient in Microsoft Programs, including but not limited to word, excel, PowerPoint, project management (Gantt), Outlook/Calendar, and Adobe Acrobat.
- Ability to Travel up to 30 – 50 %.
- Preferred – Experience in drugs, biologics and medical device clinical studies.
Must be a US citizen.
Must be able to pass background and drug testing.
THIS IS A FEDERAL CONTRACT.
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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Send Resume to Allied Technologies & Consulting, LLC
100 Tuscanney Dr., Ste. B2
Frederick, MD 21702
Job Category: Clinical Research Associate