Tweet
Research Protocol and Data Management Coordinator
PLEASE NOTE: This position is located at The Walter Reed National Military Medical Center in Bethesda, Maryland. This is a GRANT funded position through the University of Delaware.
Applicants must submit a letter of application, resume, and contact information for three references to http://www.udel.edu/udjobs/ ; Job Opening ID: 100767
The Research Protocol and Data Management Coordinator supports research studies at The Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Serves under the direction of the BADER Consortium Clinical Research Manager. Performs a broad range of administrative duties in support of ensuring the research program remains in compliance with the Federal Common Rule regulations to protect human research subjects. The incumbent is responsible for managing preparation, submission, and maintenance of research protocols submitted by researchers associated with the BADER Consortium, and coordinating actions throughout the approval process. Facilitates the preparation, submission, and tracking of IRB documentation. Following protocol approval, research protocol record maintenance and data management are primary responsibilities of the position. Requests, compiles, and analyzes data to develop special and periodic reports required by the facility Research Director, MTF, CIRO, or external agencies, as requested. Protects human subjects by being aware of ethical, legal and procedural requirements for protocol development. Entry of all onsite study information and data into the PDMS; learns to model protocols into PDMS. Maintain knowledge of all compliance issues, such as human subject protections and responsible conduct of research.
To accomplish these broad program objectives, the incumbent must assist with coordination with members of other federal agencies, e.g. the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP) in Health and Human Services, the Clinical Investigation Regulatory Office (CIRO), Medical Command (MEDCOM) and the Regulatory Compliance and Quality office of the Medical Research and Materiel Command. (MRMC). Coordination with state and private universities and private research organizations/ institutes is also a function.
This is a full-time, grant funded position and continuation of the position is contingent upon continued funding. Notice of non-renewal is not required.
QUALIFICATIONS:
• Bachelor’s degree required in science or healthcare-related field
• At least 3 years’ experience in clinical research setting required
• Experience in or exposure to research in a hospital setting is preferred.
• Experience clinical administration and/or clinical documentation preferred
• Experience with clinical trials preferred
• CITI certification is strongly preferred.
• Experience with IRB administration and data management is preferred
• Interpersonal skills to work effectively with patients and staff
• Familiarity and experience with research design, data collection and computerized systems, and experience with laboratory management and administrative activities highly preferred
• Ability to learn new software quickly, troubleshoot computer related issues, and provide a high attention to detail
SALARY AND BENEFITS: Competitive and commensurate with experience and qualifications. Professionals at the University have regularly received annual cost-of-living and merit salary increases and the benefits package is one of the best in the nation, supporting inclusion of UD in the Chronicle of Higher Education's "Great Colleges to Work For" program for the past 3 years.
HOW TO APPLY: Go to: https://wahrprd.nss.udel.edu:4450/ps...=A&SiteId=888&
Use the Advanced Search option to search for Job Opening ID: 100767
REVIEW OF APPLICATIONS: Nominations and expressions of interest will be held in confidence and references will not be contacted without the candidate's permission. Applicants must submit a letter of application, resume, and contact information for three references to http://www.udel.edu/udjobs/. For inquiries, contact: Rachel Strickland, Search Committee Chair, 302-831-7267, rs@udel.edu
www.bader-c.org BADER Consortium, University of Delaware, 5 Innovation Way, Suite 300, Newark, Delaware 19711
PLEASE NOTE: This position is located at The Walter Reed National Military Medical Center in Bethesda, Maryland. This is a GRANT funded position through the University of Delaware.
Applicants must submit a letter of application, resume, and contact information for three references to http://www.udel.edu/udjobs/ ; Job Opening ID: 100767
The Research Protocol and Data Management Coordinator supports research studies at The Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. Serves under the direction of the BADER Consortium Clinical Research Manager. Performs a broad range of administrative duties in support of ensuring the research program remains in compliance with the Federal Common Rule regulations to protect human research subjects. The incumbent is responsible for managing preparation, submission, and maintenance of research protocols submitted by researchers associated with the BADER Consortium, and coordinating actions throughout the approval process. Facilitates the preparation, submission, and tracking of IRB documentation. Following protocol approval, research protocol record maintenance and data management are primary responsibilities of the position. Requests, compiles, and analyzes data to develop special and periodic reports required by the facility Research Director, MTF, CIRO, or external agencies, as requested. Protects human subjects by being aware of ethical, legal and procedural requirements for protocol development. Entry of all onsite study information and data into the PDMS; learns to model protocols into PDMS. Maintain knowledge of all compliance issues, such as human subject protections and responsible conduct of research.
To accomplish these broad program objectives, the incumbent must assist with coordination with members of other federal agencies, e.g. the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP) in Health and Human Services, the Clinical Investigation Regulatory Office (CIRO), Medical Command (MEDCOM) and the Regulatory Compliance and Quality office of the Medical Research and Materiel Command. (MRMC). Coordination with state and private universities and private research organizations/ institutes is also a function.
This is a full-time, grant funded position and continuation of the position is contingent upon continued funding. Notice of non-renewal is not required.
QUALIFICATIONS:
• Bachelor’s degree required in science or healthcare-related field
• At least 3 years’ experience in clinical research setting required
• Experience in or exposure to research in a hospital setting is preferred.
• Experience clinical administration and/or clinical documentation preferred
• Experience with clinical trials preferred
• CITI certification is strongly preferred.
• Experience with IRB administration and data management is preferred
• Interpersonal skills to work effectively with patients and staff
• Familiarity and experience with research design, data collection and computerized systems, and experience with laboratory management and administrative activities highly preferred
• Ability to learn new software quickly, troubleshoot computer related issues, and provide a high attention to detail
SALARY AND BENEFITS: Competitive and commensurate with experience and qualifications. Professionals at the University have regularly received annual cost-of-living and merit salary increases and the benefits package is one of the best in the nation, supporting inclusion of UD in the Chronicle of Higher Education's "Great Colleges to Work For" program for the past 3 years.
HOW TO APPLY: Go to: https://wahrprd.nss.udel.edu:4450/ps...=A&SiteId=888&
Use the Advanced Search option to search for Job Opening ID: 100767
REVIEW OF APPLICATIONS: Nominations and expressions of interest will be held in confidence and references will not be contacted without the candidate's permission. Applicants must submit a letter of application, resume, and contact information for three references to http://www.udel.edu/udjobs/. For inquiries, contact: Rachel Strickland, Search Committee Chair, 302-831-7267, rs@udel.edu
www.bader-c.org BADER Consortium, University of Delaware, 5 Innovation Way, Suite 300, Newark, Delaware 19711