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Research Admin CRO
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90669725

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  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
  20 Views, 0 Applications  
Research Admin CRO
Under the direction of the System Executive Director, DMC Clinical Research Office, has the primary responsibility of planning and coordinating regulatory and operational activities of behavioral/medical studies and drug and device trials.

Acts as liaison between research department and collaborating hospitals and sponsors for research purposes and to coordinate trial initiations, monitor activities, provide protocol training, and so forth. Coordinates and designs processes to ensure compliance to protocol and quality data acquisition, including but not limited to procedures for subject enrollment and registration for DMC clinical services. Assists in oversight of submission to DMC Research Review Portal, triaging of studies for billing analysis, coordinating collection of patient enrollment data, accounting and finance reports, in addition to IRB documents for studies across the DMC.

Provides support to investigators, physicians and fellows in study protocol development, regulatory documentation, and protocol procedures. Oversees study procedures and maintains study documentation in accordance with established Good Clinical Practice (GCP) guidelines, Code of Federal Regulations (CFR) Title 21-regulations, and applicable statute(s). Prepares and submits necessary documentation to Institutional Review Board (IRB) for approval prior to initiation of study, as well as ongoing reporting. Assists with completion of case report forms and query resolutions for sponsoring agencies in order to facilitate prompt and full payment of agreements and to ensure the goals of time, cost, and quality are met. In collaboration with study investigator(s) and in a manner consistent with the Declaration of Helsinki and Health Insurance Portability and Accountability Act (HIPAA), assures the protection of the patient's rights and safety. Reports adverse events according to IRB, Sponsor, and FDA guidelines.

May facilitate external monitoring and auditing of research activities.

As assigned, interviews, schedules, orients, and trains research assistants and ancillary staff. Reviews clinical site agreements (contracts) and acts as liaison between involved parties. Works with patient financial services to obtain pre-certification for research-related procedures from insurance companies. Ensure that charges for study-related care and subject stipends are properly documented and charged to study guarantor accounts. Assists in data collection, quality control review, analysis of results, and preparation for presentation or submission for publication. Responsible for maintaining awareness of new regulatory issues and identifies new research activities. Provides support to supplementary projects that advance the goals of the department and the institution's mission, vision, and values.

BS/BA Degree.

Four years of progressively more responsible project management experience in a health care setting.

**Job:** _Non-Clinical/Administrative_

**Organization:** _Detroit Medical Center Shared Services_

**Title:** _Research Admin CRO_

**Location:** _MI-Detroit_

**Requisition ID:** _1805020095_

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