Posted today
Public Trust
Mid Level Career (5+ yrs experience)
Unspecified
IT - Data Science
Fort Detrick, MD (Off-Site/Hybrid)
As a Clinical Research Associate/Clinical Research Monitor you will help ensure today is safe and tomorrow is smarter. Our work depends on a Clinical Research Associate/Clinical Research Monitor joining our team to support the development of military-focused medical products.
Seeking a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoW (Dept. of War) 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 a Clinical Research Associate/Clinical Research Monitor 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:
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 NACI T1 security investigation prior to start date.
Education:
Bachelors degree, 4+ year’s experience supporting clinical research
Required Experience:
5+ years of experience supporting clinical monitoring
Required Technical Skills:
Clinical trial Monitoring, Clinical Trial Monitoring Plans, Monitoring Visits, Site visit reports
Security Clearance Level:
NACI T1
Required Skills and Abilities:
Excellent written and verbal communication
Preferred Skills:
Clinical Trial Monitoring support
Experience in a military research environment
Location:
Hybrid (Ft. Detrick, MD)
Citizenship Required:
US Citizenship
Frequently Asked Vendor Questions:
What is the mission of the program/contract? To support the development of military relevant medical products.
What will a typical workday look like for the Contractor? Is this a team setting? Clinical monitors support the monitoring of active clinical trials by performing interim monitoring visits, reviewing study documents and ensuring clinical trials are executed as described in the study protocol. Staff work with clinical trial sites and generate reports post visit.
What are the top three skillsets the candidate should have? Experience supporting clinical trials, experience conducting site visits and generating site visit reports.
What is the interview process? How many interviews until decision is made? Audio only or audio/video or in-person? One interview with the contract task lead and sr. CRA. Interview will be conducted remotely via team.
What government agency/customer does the contract support? The Office of Regulated Activities
What is the length of the contract? What Option Year is it currently in? When is re-compete? Current Task Order ends July 31st. We anticipate an RFP or a direct award, but we are waiting on the official notification from the contracting office on the customer side.
What is the Hybrid schedule? Report on site 2 day/weeks
What is the Public Trust process? NACI (T1) is required prior to start. Takes ~3-4 weeks.
Seeking a Clinical Research Monitor to support the Office of Regulated Activities (ORA) under the DoW (Dept. of War) 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 a Clinical Research Associate/Clinical Research Monitor 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:
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 NACI T1 security investigation prior to start date.
Education:
Bachelors degree, 4+ year’s experience supporting clinical research
Required Experience:
5+ years of experience supporting clinical monitoring
Required Technical Skills:
Clinical trial Monitoring, Clinical Trial Monitoring Plans, Monitoring Visits, Site visit reports
Security Clearance Level:
NACI T1
Required Skills and Abilities:
Excellent written and verbal communication
Preferred Skills:
Clinical Trial Monitoring support
Experience in a military research environment
Location:
Hybrid (Ft. Detrick, MD)
Citizenship Required:
US Citizenship
Frequently Asked Vendor Questions:
What is the mission of the program/contract? To support the development of military relevant medical products.
What will a typical workday look like for the Contractor? Is this a team setting? Clinical monitors support the monitoring of active clinical trials by performing interim monitoring visits, reviewing study documents and ensuring clinical trials are executed as described in the study protocol. Staff work with clinical trial sites and generate reports post visit.
What are the top three skillsets the candidate should have? Experience supporting clinical trials, experience conducting site visits and generating site visit reports.
What is the interview process? How many interviews until decision is made? Audio only or audio/video or in-person? One interview with the contract task lead and sr. CRA. Interview will be conducted remotely via team.
What government agency/customer does the contract support? The Office of Regulated Activities
What is the length of the contract? What Option Year is it currently in? When is re-compete? Current Task Order ends July 31st. We anticipate an RFP or a direct award, but we are waiting on the official notification from the contracting office on the customer side.
What is the Hybrid schedule? Report on site 2 day/weeks
What is the Public Trust process? NACI (T1) is required prior to start. Takes ~3-4 weeks.
group id: asdinc
