GDIT in seeking a ClinicalResearch Coordinator in support of the Malaria Department for the Naval Medical Research Center Clinical Trials Center (NMRC CTC) located at Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. The NMRC CTC conducts clinical trials of candidate vaccines designed to protect military against infectious diseases, such as malaria. GDIT provides scientific, technical and programmatic support services to the Malaria Department. US Citizenship is required for this position. This position will require earlier hours and flexibility during peak season. This position has the potential to require communication with recruited subjects using a NMRC-provided cell phone outside of normal working hours (e.g. evenings or weekends as needed).
GDIT in seeking a ClinicalResearch Coordinator to clinical trials designed to protect the military
In this role, a typical day will include:
Coordinate research activities of assigned IRB-approved study protocols
Ensure all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations.
Coordinate with the PI to ensure all resources, including supplies, are available as necessary to meet research timelines.
Ensure effective communication with patients, their families and/or significant others, providers, clinical staff, clerical staff, and collaborative institutions.
Report data on research studies in accordance with IRB-approved protocols and applicable regulations with final government approval.
Assist with recruiting and screening patients using protocol inclusion/exclusion criteria and refer eligible patients to the PI for final evaluation.
Assist Government personnel with ensuring the consent process has taken place effectively and all questions are answered satisfactorily and documented.
Assist with providing education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.
Assist with coordinating the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.
Maintain proficiency required to coordinate clinical research such as: communication skills and leadership skills as the coordinator of complex human and animal research protocols.
Observe universal precautions and OSHA standards when processing or handling specimens.
Ensure reporting of adverse events to the governing agency (IRB) and sponsors as required by protocol and regulations.
Ensure in the research study is in with regulations and standard operating procedures, to include complete documentation of status and progress.
Assist with maintaining detailed documentation of the research study as required by the protocol and the PI
Effectively communicate on a regular basis with the PI, Research Scientist, or staff regarding the conduct of the research study.
Assist with producing protocol amendments and continuing reviews in the eIRB system, subject to final Government approval.
Provides other administrative duties which directly correspond to the aforementioned duties (above).
2+ years experience as a CRC
Preferred - Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from the start of performance.
Must be proficient in medical record reviews and searches. In order to accomplish this task, the contractor personnel must have experience in the use of clinical computer systems such as CliniComp (Essentris), Cerner (MHS-Genesis) or SPSS.
Proficient in scheduling and communicating with participants.
Proficient in writing and editing to assist PIs in preparation of their manuscripts, scientific abstracts, and/or research presentations.
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 a US citizen with the ability to obtain a favorable NACLC T3 security investigation prior to start date.
WHAT GDIT CAN OFFER YOU:
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
Full-flex work week
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/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 veteran status, or any other protected class.