Clinical Trials Proj Spec I A
Rochester, New York
Employer: University of Rochester
Industry: Facilities Support
Salary: $34.16 per hour
Job type: Full-Time
Opening
Full Time 40 hours Range URG 108 CCRC
Schedule
8:30 AM-5 PM
Responsibilities
GENERAL PURPOSE:
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
JOB DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $24.40 - $34.16 Hourly
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Full Time 40 hours Range URG 108 CCRC
Schedule
8:30 AM-5 PM
Responsibilities
GENERAL PURPOSE:
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
JOB DUTIES AND RESPONSIBILITIES:
- 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
- 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
- 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.
- Utilizes internal tracking system to monitor IRB, medical license and certification expiration and contacts sites to obtain renewals as appropriate to study work instructions.
- 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.
- Archives data media, event source documents, regulatory and correspondence documents with detailed tracking and appropriate document renewal to meet study-specific and regulatory requirements.
- Develops site communication during study start up, study maintenance phase and close-out.
- 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.
QUALIFICATIONS:
- Bachelor's degree required.
- Less than 1 year of experience in research; or equivalent combination of education and volunteer experience required.
- Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred.
- Excellent interpersonal and communication skills, including writing skills preferred.
- Strong attention to detail and organizational skills preferred.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $24.40 - $34.16 Hourly
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Created: 2024-05-31
Reference: 253191
Country: United States
State: New York
City: Rochester
ZIP: 14608
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