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University of Rochester Human Subject Research Coordinator, Neurosurgery - 231778 in Rochester, New York

Human Subject Research Coordinator, Neurosurgery Job ID 231778

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 053 Department of Neurosurgery

Schedule

8 AM-4:30 PM

Responsibilities

POSITION SUMMARY:

The position is for an experienced human subject research coordinator to join a dynamic , cross­ functional team working in the field of translational clinical research. The research coordinator will be an integral member of an adjudication committee assisting in determining subject eligibility for a global registration trial. The successful candidate will also assist in coordinating other industry- and investigator-initiated research studies in surgical study populations .

Applicants must be able to work independently and have clinical research experience . This role oversees and coordinates human subject research activities for single or multiple sites .

Develops , implements and evaluates recruitment strategies , information and data systems and study management systems . Participates in the planning , development and implementation of study design , budgets , protocols , consent forms , processes and policies that may include multiple therapeutic areas . Participates in the development , review and approval of case report forms (CRFs) and study-specific procedure manuals and documents .

SUPERVISION AND DIRECTION RECEIVED:

Under the direct supervision of the Principal Investigator with oversight from the Vice Chair for Clinical Research

TYPICAL DUTIES:

Adjudication Committee (45%)

  • In a timely manner , reviews documentation received from sites in study database to ensure receipt of all required information . (10%)

  • Conducts preliminary review to ascertain if subject meets eligibility requirements to be included in trial. (10%)

  • Forwards thoroughly reviewed information on to expert clinicians for final eligibility determination , assisting with answering questions they may have as applicable . (5%)

  • Maintains high degree of knowledge on study protocol , SOPs , and chronic pain syndrome under study . (5%)

  • Maintains continuous communication with adjudication committee and all relevant stakeholders . (5%)

  • Directs the activities of other study coordinator staff and relevant others to gather , compile and analyze study information . ( 5%)

  • Coordinates and monitors financial data for budget and variance reporting and for compliance with all institutional requirements for adequate system controls . ( 5%)

    Study Coordinator Duties (50%)

  • Supports research studies including:

  • Study Visits : Recruits , consents , schedules, and conducts research subject visits in accordance with study protocol , coordinating these visits with the Principal Investigator. May draw blood , processes samples , and performs testing such as ECG and treadmill tests, depending on the protocol. Coordinates and documents dispensing and returning of study drugs/materials .

  • Regulatory Oversight: Oversees and manages the regulatory details for assigned research studies . Manages and submits study applications, amendments , and continuing reviews for IRB approval (local and central) .

  • Data Management: Develops and/or manages databases (e . g . , EDC , REDCap) for research studies. Ensures data entered and queries responded to in a timely manner .

  • Liaison : Serves as the liaison between cross-functiona l research team , study sponsors , and IRB to facilitate communication , resolve issues , and enhance collaboration .

  • Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance w i th Good Clinical Practice (GCPs) guidelines and sponsor requirements.

    Continuing Educat i on (5% )

  • Demonstrates accountability for continuous learning related to clinical research .

  • Keeps current with study-specific training , including understanding specific details of study protocol , all relevant sponsor and institutional policies , standard operating p r ocedures , and guidelines .

  • Participates in tra i ning sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines , federal and state polices and laws , institutional certifications, industry standards and best practices , and trends in relevant therapeutic areas .

    Other projects and job duties as assigned .

    QUALIFICATIONS:

  • Bachelor ' s degree and three years of experience in human subject research coordination required; or an equivalent combination of education and experience.

  • RN degree and phlebotomy training preferred .

  • Professional research coordinator certification (e . g ., SoCRA or ACRP) preferred .

  • Knowledge of word processing , spreadsheets , and electronic data capture (EDC) software preferred .

  • Must be independent and organized , have excellent communication skills (including wr i tten communication) , strong attent i on to detail , and strong interpersonal skills .

    T he University of Roche s ter i s an E q u al O p portunit y E m ployer M ino ri tie s/ F emale s / Protected V eterans / Disabled.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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