Job Description
Responsibilities for this Position
Location: USA MD Fort Detrick
Full Part/Time: Full time
Job Req: RQ195862
Type of Requisition: Pipeline
Clearance Level Must Currently Possess: None
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACLC (T3)
Job Family: Medical Affairs
Job Qualifications: Skills: Clinical Research, Data Compilation, Research Protocols
Certifications: None
Experience: 4 + years of related experience
US Citizenship Required: Yes
Job Description: GDIT's Military Health team is hiring a Clinical Research Associate to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH. This is a hybrid position and will report onsite 1-2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities.
- Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), 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-Prepare protocol deviations and violation and non-compliance reports
- Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor's regulatory file.
- Prepare/review calibration and maintenance records, which are records kept at the clinical site that 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
WHAT YOU'LL NEED TO SUCCEED: - Bachelors degree, 4+ year's experience supporting clinical research
- Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file.
- Experience providing remote evaluation of the study data
- Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.
- Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.
- 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: - Challenging work that makes a real impact on the world around you
- Internal mobility team dedicated to helping you own your career
- 401K with company match
- Diverse, highly collaborative teams
- Professional development, education assistance, certification and training opportunities
#GDITHealth #militaryhealth #GDITLabScienceJobs #GDITFedHealthJobs The likely salary range for this position is $72,509 - $80,500. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Scheduled Weekly Hours: 40
Travel Required: Less than 10%
Telecommuting Options: Hybrid
Work Location: USA MD Fort Detrick
Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day. We create opportunities for our people to lead and learn simultaneously. From securing our nation's most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
PI264942330
GDIT's Military Health team is hiring a Clinical Research Associate to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland. The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring. The CRA will provide clinical trial monitoring to ensure all sponsor required trial monitoring is conducted and all deliverables are provided according to 21 CFR 312 and ICH. This is a hybrid position and will report onsite 1-2 days a week at Ft. Detrick in Frederick, Maryland. Must reside within commuting distance. HOW YOU WILL MAKE AN IMPACT: - Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities.
- Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), 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-Prepare protocol deviations and violation and non-compliance reports
- Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor's regulatory file.
- Prepare/review calibration and maintenance records, which are records kept at the clinical site that 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
WHAT YOU'LL NEED TO SUCCEED: - Bachelors degree, 4+ year's experience supporting clinical research
- Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor's regulatory file.
- Experience providing remote evaluation of the study data
- Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor's regulatory file.
- Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.
- 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: - Challenging work that makes a real impact on the world around you
- Internal mobility team dedicated to helping you own your career
- 401K with company match
- Diverse, highly collaborative teams
- Professional development, education assistance, certification and training opportunities
Job Tags
Holiday work, Full time, Temporary work, Part time, Work experience placement, Immediate start, Remote job, Worldwide, Flexible hours, 2 days per week, 1 day per week,