Clinical Trials Proj Mgr

GENERAL PURPOSE:With direction from the Clinical Research Manager, coordinates study activities for large multi-site clinical trials within the Clinical Cardiovascular Research Center. Assists the manager in training of regulations, policies and practices related to sponsored studies. Works independently and exercises good judgement in day-to-day operations.Coordinates data acquisition for research studies and associated sub-studies, including contact with study subjects, eligibility screening, collecting appropriate enrollment, and follow¿up data, obtaining informed consent, analyzing and interpreting data, disseminating study information to subjects and physicians, and maintaining quality control of information in database.RESPONSIBILITIES:

Corresponds in writing and by phone with clinical trials enrolling site personnel to obtain information for completing study data including resolving discrepancies using eDC system and manually generated data reports.Ensures compliance with applicable regulatory requirements and IRB standards and ensures integrity of all study data collected.

Plans, develops and implements study design, procedures, protocols, and consents for multi-site clinical trials.Assists in development of case report forms and study specific procedure manuals.

Support study recruitment and retention through effective communication with clinical coordinators and registry subjects. Initiates telephone and email contact to inquire about unreturned registry enrollment and follow up questionnaires.

Collaborate with programming staff to develop and modify data forms, data reconciliation programs and procedures for data quality control.Coordinate and maintain data base as well as reconcile data discrepancies to ensure clean data for reports and publications. Analyze data and prepare reports for publication or grant requests and for progress reports.

Communicates with subjects and physicians to collect, interpret and record data variables as appropriate by phone interview and/or questionnaire to complete study data forms in web-based database, per study protocol.Review and approve data coded by other members of the study team, reviewing source documentation.

Keeps abreast of trends in cardiac research by reading current research literature and attending appropriate lectures.Shares relevant literature with study staff to help ensure their growing knowledge of study-related topics

QUALIFICATIONS:

Bachelor¿s degree with major course work in an appropriate health, social or technical field preferred

3-5 years of related experience required;

Or an equivalent combination of education and experience required.

Must be detail oriented, highly organized, and possess outstanding interpersonal skills and communication skills (both verbal and written) required.

Must have the ability to work effectively independently and in a team environment required.

Self-motivated and directed with the ability to effectively prioritize and execute tasks required.

Excellent organization skills required.

Some background in genetics helpful preferred.

Should be proficient with Windows 10 and Microsoft Office, particularly Word and Outlook preferred.

Human Subjects Research Program required

Conducting Clinical Trials Course 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 ApplyAll applicants must apply online.EOE Minorities/Females/Protected Veterans/DisabledPay RangePay Range: $65,815 - $95,723 AnnuallyThe 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.Apply for Job

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Location: School of Medicine & Dentistry

Full/Part Time: Full-Time

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