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University of Rochester Clinical Research Assoc (S) - 227867 in Rochester, New York

Clinical Research Assoc (S) Job ID 227867

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

Full Time 40 hours Grade 053 CCRC

Schedule

8:30 AM-5 PM

Responsibilities

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.

Supervision:

General direction and administrative supervision from the study-assigned Clinical Research Manager and/or Research Program Manager of the CCRC.

50% Coordinates the activities of enrolling center staff at member institutions and core laboratories as they relate to clinical/study responsibilities including training, data collection, operations, and communication with travel to institutions as necessary.

20% Communicates study operational changes, regulatory and clinical data issues, including reconciliation of problems and data tracking.

10% Communicates daily operational issues and subject enrollment.

10% 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.

5% Interacts with study sponsors regarding study startup, ongoing study activities, and sponsor requests.

5% 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.

15% 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.

10% 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.

10% 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.

10% 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.

5% 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.

Requirements:

Bachelor’s degree and 3-5 years of experience in industry sponsored clinical research coordination or an equivalent combination of education and experience with ability to effectively prioritize and execute tasks in a high-pressure environment. Cardiology, clinical training and/or regulated clinical trial experience helpful with strong organizational and communication skills. Strong comfort level and proficiency with personal computer systems and clinical trial web applications strongly preferred.

PLEASE CHECK ALL THE APPROPRIATE CATEGORIES OF PATIENTS SERVED BY THE EMPLOYEE.

Neonate N/A

Pediatric N/A

Adolescent N/A

18-65 years

Over 65 years N/A

JCAHO (MA1.4.3.1) requires that the performance appraisals of staff, without clinical privileges, who participate in the assessment, treatment or care of patients, address the ages of the patients served. Technical staff including phlebotomists are included in this definition.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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