Clinical Research Coordinator
Eisenhower Army Medical Center - Fort Gordon, GA

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DESCRIPTION

The Clinical Research Coordinator oversees and administers research study and associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol and regulatory requirements are followed. May recruit and coordinate research subjects, as appropriate, and serves as principle administration liaison for the project. Oversees and coordinates the provision of administrative and staff services to investigators; develops and maintains record keeping systems and procedures.

The objective is to provide support for the MyFitnessPal Application Research Project, including: assisting with research for the mobile health (mHealth) and weight loss surgery research for Dwight D. Eisenhower Army Medical Center (DDEAMC) scientists, residents and researchers, provide on-going communications with researchers, assist with preparation of reports and manuscripts for publication, data analysis.

DUTIES

  • Work with Principal Investigators (PI), associate investigators (AI), research team members, and other DDEAMC staff, residents, and collaborators in development of, preparation for, conduct of, and closeout of clinical research studies.
  • Occasionally be available outside of business hours to meet or phone patients or research subjects on a case-by-case basis.
  • Responsible for providing services to coordinate patient research
  • Assist with research for the mobile health (mHealth) and weight loss surgery research for DDEAMC scientists, residents and researchers, provide on-going communication with researchers, assist with the preparation of reports and manuscripts for publication, assist with data analysis and the interpretation of study findings, communicate frequently with the investigators concerning projects via email, team meetings, and phone contact
  • Assist investigators with the completion of supported projects.
  • Assist PIs with Protocol Package Development and Submission to include accurate, timely, and complete entry of required documents in IRBNet. (Timeframe for completion to be determined by Project Manager or designee).
  • Assisting PIs with correcting/making required administrative corrections/changes in submitted protocol package as requested/directed by Research Regulatory Office
  • Assisting PIs with Protocol Modification: Timeframe for completing modifications stipulated by IRB/IACUC for approval to include accurate, timely, and complete entry of required documents in IRBNet to be determined by Research Project Manager.
  • Protect and assist PI with protecting the rights and welfare of all human research participants in accordance with Federal regulations, MEDCOM, DDEAMC HRPP, and sponsoring agency policies and procedures.
  • Work with PIs to ensure that clinical research studies are conducted in accordance with IRB approved protocols, Federal and Army regulations, MEDCOM and DDEAMC policies, and sponsor agency requirements. Document the training in accordance with DDEAMC policies. Maintain documentation of this training in accordance with DDEAMC policies.
  • Track and assist PIs in assuring that all persons 'engaged' in the research project have met training requirements in accordance with Federal regulations, DDEAMC policies, and sponsoring agency policies and procedures. Documents dates of training and obtains signatures of study personnel on study specific training logs.
  • Develop and implement or assist PIs with developing and implementing recruitment strategies in accordance with Institutional Review Board (IRB) requirements and approval.
  • Conduct subject recruitment activities and study procedures as required by specific protocols including prescreening, conducting study visits, tracking and distributing test articles, and educating subjects.
  • Accurately screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
  • Conduct or participate in the informed consent process including interactions with research participants and answering questions related to the study. Assure information is documented on the appropriate forms. Assure that amended consent forms are appropriately implemented and signed.
  • As appropriate to their role, the contracted personnel shall review, author, or assist PIs in reviewing/authoring publications, posters and podium presentations.
  • Analyze and manage research/study information and data: initiate and conduct ongoing database analyses to support clinical research objectives; review scientific data and participate in reviewing ongoing summary data; complete study documentation and maintain study files in accordance with regulations, DDEAMC policies, and sponsor requirements; manage study documentation including confirming that required documents are archived and available; present data and participate in the presentation of data at internal DDEAMC meeting; maintain detailed records of research conducted (produce accurate and timely reports as requested); and establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other material.
QUALIFICATIONS

  • Bachelor's Degree required from an accredited college or university in the field of study related to the position being requested such as health sciences.
  • Minimum of two years of demonstrated clinical research coordinator experience
  • Clinical Research Coordinator certification
  • Demonstrated knowledge of and competence with spreadsheet documents and Apple products (specifically the iPad, iPhone, and other handheld devices), application downloads and be able to train individuals in these functions.
  • Work with Principal Investigators (PI), associate investigators (AI), research team members, and other DDEAMC staff, residents, and collaborators in development of, preparation for, conduct of, and closeout of clinical research studies.
  • Occasionally be available outside of business hours to meet or phone patients or research subjects on a case-by-case basis.
  • Responsible for providing services to coordinate patient research
  • Assist with research for the mobile health (mHealth) and weight loss surgery research for DDEAMC scientists, residents and researchers, provide on-going communication with researchers, assist with the preparation of reports and manuscripts for publication, assist with data analysis and the interpretation of study findings, communicate frequently with the investigators concerning projects via email, team meetings, and phone contact
  • Assist investigators with the completion of supported projects.
  • Assist PIs with Protocol Package Development and Submission to include accurate, timely, and complete entry of required documents in IRBNet. (Timeframe for completion to be determined by Project Manager or designee).
  • Assisting PIs with correcting/making required administrative corrections/changes in submitted protocol package as requested/directed by Research Regulatory Office
  • Assisting PIs with Protocol Modification: Timeframe for completing modifications stipulated by IRB/IACUC for approval to include accurate, timely, and complete entry of required documents in IRBNet to be determined by Research Project Manager.
  • Protect and assist PI with protecting the rights and welfare of all human research participants in accordance with Federal regulations, MEDCOM, DDEAMC HRPP, and sponsoring agency policies and procedures.
  • Work with PIs to ensure that clinical research studies are conducted in accordance with IRB approved protocols, Federal and Army regulations, MEDCOM and DDEAMC policies, and sponsor agency requirements. Document the training in accordance with DDEAMC policies. Maintain documentation of this training in accordance with DDEAMC policies.
  • Track and assist PIs in assuring that all persons 'engaged' in the research project have met training requirements in accordance with Federal regulations, DDEAMC policies, and sponsoring agency policies and procedures. Documents dates of training and obtains signatures of study personnel on study specific training logs.
  • Develop and implement or assist PIs with developing and implementing recruitment strategies in accordance with Institutional Review Board (IRB) requirements and approval.
  • Conduct subject recruitment activities and study procedures as required by specific protocols including prescreening, conducting study visits, tracking and distributing test articles, and educating subjects.
  • Accurately screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
  • Conduct or participate in the informed consent process including interactions with research participants and answering questions related to the study. Assure information is documented on the appropriate forms. Assure that amended consent forms are appropriately implemented and signed.
  • As appropriate to their role, the contracted personnel shall review, author, or assist PIs in reviewing/authoring publications, posters and podium presentations.
  • Analyze and manage research/study information and data: initiate and conduct ongoing database analyses to support clinical research objectives; review scientific data and participate in reviewing ongoing summary data; complete study documentation and maintain study files in accordance with regulations, DDEAMC policies, and sponsor requirements; manage study documentation including confirming that required documents are archived and available; present data and participate in the presentation of data at internal DDEAMC meeting; maintain detailed records of research conducted (produce accurate and timely reports as requested); and establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other material.

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