Clinical Trials Proj Mgr - Hybrid Position
Rochester, New York
Employer: University of Rochester
Industry: Facilities Support
Salary: $58800 - $82300 per year
Job type: Full-Time
Opening
Full Time 40 hours Grade 053 CCRC
Schedule
8:30 AM-5 PM
Responsibilities
HYBRID POSITION
GENERAL PURPOSE:
Coordinates study activities for large multiple site international clinical trials and core laboratories for FDA, NIH and Investigator Sponsored Research clinical trials. Assists Manager in training of regulations, policies, and industry practices related to sponsored studies to meet clinical research compliance standards with considerable latitude for the exercise of independent judgment and initiative in support of clinical research conducted under regulatory requirements.
JOB DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $58,800 - $82,300 Annually
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 Grade 053 CCRC
Schedule
8:30 AM-5 PM
Responsibilities
HYBRID POSITION
GENERAL PURPOSE:
Coordinates study activities for large multiple site international clinical trials and core laboratories for FDA, NIH and Investigator Sponsored Research clinical trials. Assists Manager in training of regulations, policies, and industry practices related to sponsored studies to meet clinical research compliance standards with considerable latitude for the exercise of independent judgment and initiative in support of clinical research conducted under regulatory requirements.
JOB DUTIES AND RESPONSIBILITIES:
- Communicates study operational changes, regulatory and clinical data issues, including reconciliation of problems and data tracking.
- Communicates daily operational issues and subject enrollment.
- Collects all source documents and administrative documents related to activation of enrolling centers and core laboratories including notification of any required corrective actions to meet regulatory compliance including tracking and notification as appropriate with strict adherence to document control procedures.
- Ensures compliance with applicable regulatory requirements and IRB standards. Ensures integrity of all study data collected. Ensures protocol activities are administered consistently across study sites according to internal standard operating procedures and work instructions.
- Plans and implements administrative phases of multi-center research projects to ensure objectives will be accomplished in accordance with prescribed priorities, time limitations, and funding conditions through initiation and oversight of team meetings and activities.
- Develops and writes operational procedures for data quality control and data form construction with specific attention to clinical variables and continuity including internal study-specific work instructions.
- Assists with development and implementation of recruitment strategies, information and database systems, training, invoicing, data analysis, reports, and study tracking (timeline systems) per contractual requirements.
- Maintains a good working knowledge of the cardiovascular research literature and regulatory compliance issues both in general and as it relates to the specific tasks assigned through attendance at national meetings and interactions with study sponsors.
- Interacts with study sponsors regarding study startup, ongoing study activities, and sponsor requests.
- Implements special assignments related to clinical trial including but not limited to adverse and endpoint event review, review of monitoring reports, device media, newsletters, data reports protocol deviation coding per internal and sponsor requirements.
QUALIFICATIONS:
- Bachelor's Degree in industry sponsored clinical Research Coordination required
- Or equivalent combination of education and experience required
- Ability to effectively prioritize and execute tasks in a high-pressure environment. Cardiology, clinical training and/or regulated clinical experience helpful with strong organizational and communication Strong comfort level and proficiency with personal computer system and clinical trial web applications strongly preferred.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $58,800 - $82,300 Annually
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: 2024-05-04
Reference: 250430
Country: United States
State: New York
City: Rochester
ZIP: 14608
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