Ke'aki Technologies, LLC, is a Native Hawaiian Organization (NHO) owned business. A premier government services company, Ke'aki Technologies offers a full spectrum of solutions that improve the performance and operational effectiveness of our government and Department of Defense customers. Our mission synchronized solutions are designed to deliver exactly what our customers need, when they need it. From base and range operations to biomedical defense support to telecommunications and IT services, we deliver the exact talent, tools and technologies needed to meet mission requirements.
Ke'aki Technologies has an exciting opportunity for a Clinical Research Associate. The position will be located at U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Frederick, Maryland supporting the Division of Medicine.
Working directly with the Principal Investigator within the Division of Medicine, the Clinical Research Associate will be responsible for advising staff in the execution of both intramural and extramural clinical protocols.
Job Duties Include:
Will monitor clinical studies for compliance with the pertinent regulations (United States and foreign), and assisting in preparing and modifying human use protocol, reports, ethics committee submissions, and regulatory file submissions under the guidance of the principal investigator or sub-investigator .
Provide administrative and regulatory support and develop technology based training/education tools as required by USAMRIID.
The majority of the research projects this position will support are outside of the United States, primarily in the Caucuses and East Africa, but not limited to these regions.
The employee shall perform duties and responsibilities independently based on broad guidelines and objectives provided by the supervisor and own initiative.
Assisting in study/protocol development and preparation, including developing of new research SOPs when required, review/modification of research protocols, writing of informed consent documents, and design of case report forms (CRFs).
Perform and/or study coordination, including scheduling of protocol-specific screening and follow-up visits and performing interval interviews and assessments at study visits for protocol-specific data
Maintain Complete Study Documentation, including subjects’ reports and progress notes, and document protocol deviations.
Monitor Test Article Accountability, including storage and accountability log if the study includes a test article.
Ensure proper collection, processing and shipment of laboratory specimens collected during the study.
Assist in Recording and Reporting of Study Adverse Events.
Coordinate Study Close-Out, including sponsor/monitor closeout visit.
Activities will entail coordination, actual performance, guidance, monitoring and/or oversight as directed and may occur in various combinations and times depending on workload and staffing.
Prepare Monthly Activity Reports, Screening and Volunteer Disposition logs, and Help Compile Final and Annual Reports for the Study.
In addition to the above enumerated duties and responsibilities, the Clinical Research Coordinator may be assigned new duties on an “as needed” basis in conjunction with new projects initiated by the Department Chief.
Coordinates and/or participates in the conduct of clinical research studies as a Project team member and, as directed, a team leader.
Coordinates/ performs and/or provides regulatory oversight of study activities in accordance with the approved protocols.
The candidate shall participate in the development of study plans and necessary infrastructure for the implementation of approved clinical studies/protocols.
Serve as projects principle point of contact for regulatory affairs, quality assurance and clinical monitoring issues, reviews, audits, reports, etc.
Perform as liaison between study sites as required.
Participate in meetings and presentations related to assigned duties and/or work performed.
May be required to provide training to staff and co-workers in planned clinical studies, GCP and other special knowledge/skills necessary for the conduct of assigned clinical studies.
Provide training sessions to extramural sites on GCP and protocol related training including human subject’s protection/ethics training and study specific training.
Provide administrative and logistics support for conduct of meetings and conferences.
Will be required to travel outside of the United States as needed to perform duties in support of USAMRIID research projects, and will be required to have or obtain a valid U.S. passport.
Performance is evaluated based on the completeness, accuracy and timeliness of results, conformance to established policies, standards and objectives, and, effectiveness of communications and interpersonal skills.
Education: B achelor’s degree in a field related to biomedical research/clinical trials/health science.
Experience: 2 years of recent experience coordinating human clinical research trials.
Must have at least 2 years of experience directly related to overseeing multiple concurrent clinical trials.
Certified Clinical Research Associate certification
Must have attended research-specific professional development courses such as GCP, Good Laboratory Practice (GLP), or C.E.U.-generating research courses within the past two years.
The candidate shall be knowledgeable in the areas of clinical research and regulatory affairs in matters of clinical studies, and technology based training and education programs. Specifically in staff coordination at the USAMRIID level and other coordinate Services or agencies.
Must possess computer skills preferably in the following computer software programs: Microsoft Office/Word, Excel, Access, and PowerPoint.
Clearance: The position requires a favorable NAC background check, and a signed confidentiality agreement.
Ke'aki Technologies LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays. Ke'aki Technologies is proud to be an equal opportunity employer.
For additional information on Ke'aki Technologies, LLC, please visit www.keakitech.com .
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, national origin or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.