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.

Other duties as assigned

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.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

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.

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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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