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University of Rochester Clinical Research Coord (S) - 229977 in Rochester, New York

Clinical Research Coord (S) Job ID 229977

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

Full Time 40 hours Grade 051 CRCC

Schedule

8:30 AM-5 PM

Responsibilities

Position Summary:

With direction from the Clinical Research Manager assists with coordination of clinical research management activities for large international multi-site studies within the Clinical Cardiology Research Center to be consistent with Good Clinical Practice, applicable federal regulations, and standard study-specific operating procedures.

Responsibilities:

  • 20% Participates in the development, implementation and evaluation of:

  • Study design, procedure manuals, consent forms and case report forms

  • Procedures, protocols

  • Standard Operating Procedures

  • Recruitment strategies

  • Patient and site instructions congruent with study protocol and procedures

  • Supply and equipment requirements

  • 20% Extracts and maps clinical data from test data media and analysis reports, source documents, and test procedure reports with subsequent entry of collected data using various electronic data capture systems/databases including problem resolution correspondence with enrolling sites

  • 15% Processes receipt of applicable startup paper and electronic regulatory documents for clinical trials, including but not limited to, personnel information, IRB approval, signed training, financial disclosure, electronic access, curriculum vitae, professional licensure, and certification of human subjects protection and good clinical practice education in internal electronic tracking system. Reviews documents received to confirm submission requirements met. Provides report summary to team regarding document collection status and contacts sites for missing or erred documents

  • 10% Utilizes internal tracking system to monitor IRB, medical license and certification expiration and contacts sites to obtain renewals as appropriate to study work instructions

  • 10% Corresponds in writing and by phone with enrolling site personnel to obtain information for completing study data including media and source documents media resolving discrepancies using system and manually generated metrics data reports. Includes weekly correspondence with sponsors on QA and study data issues. Provides remedial training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate

  • 10% Provides backup support for screening study subjects to cardiology enrolling unit

  • 4% Ships study-specific supply/equipment including tracking of resupply for enrolling sites including assisting Investigational Drug Service in distribution of study agent to enrolling sites

  • 3% Archives data media, event source documents, regulatory and correspondence documents with detailed tracking and appropriate document renewal to meet study-specific and regulatory requirements

  • 3% Develops site communication during study start up, study maintenance phase and close-out.

  • 3% Assists with coordination of enrolling site training meetings and on line study training sessions for research study personnel at all member institutions and training of enrolling sites

  • 2% Maintains a good working knowledge of the cardiovascular research literature and FDA compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors

    Required qualifications:

  • Bachelor’s degree and 1-2 years’ experience in clinical research coordination; or equivalent combination of education and experience. Certified Clinical Research Coordinator and nursing degree preferred. Knowledge of software preferred.

    Preferred qualifications :

  • Bachelor's degree in health or social science field and 1 year of clinical trials experience.

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

  • Excellent interpersonal and communication skills, including writing skills.

  • Strong attention to detail and organizational skills.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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