General Dynamics Information Technology – Federal Civilian Division is looking for a Clinical Research Associate to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland. Duties include:
Coordinate the research activities of IRB-approved study protocols.
Support and conduct research in conjunction with the PIs of the assigned IRB-approved protocols.
Support the PIs of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations.
Recruit and screen subjects using protocol inclusion/exclusion criteria.
Administer and collect questionnaires from patients and healthcare providers at study sites.
Observe patient care teams and complete teamwork questionnaires at local study sites.
Assign appropriate subject identification number per protocol design.
Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.
Input research data into database.
Report adverse events to the IRB-protocol PI for submission to governing agencies and sponsors as required by protocol and regulations.
Evaluate compliance of research subject to protocols and complete documentation of status and progress.
Conduct telephone or face-to-face interviews and mail government approved information for follow-up visits.
Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigators File Binder/Regulatory Binder.
In collaboration with PIs and assigned medical monitor, prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors, and other organizations as required by regulation and/or the protocol.
In collaboration with key research personnel and investigators, process and prepare specimens for lab analysis and shipping.
Interact on a regular basis with the PI regarding the conduct of the research study.
Respond to research participants in an efficient and timely manner and documents interactions appropriately.
Observe safety regulations when working in ambulatory care spaces and inpatient wards (such as the use of government provided personal protective equipment (PPE)).
Provide other research support duties that are within the scope of work.
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).
2+ years experience supporting clinical research
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 highly organized, detail oriented, and perform independently.
Have excellent Microsoft Excel Spreadsheet skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
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.