Clinical Trials Proj Mgr

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Job Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype

Regular

Time Type

Full time

Scheduled Weekly Hours

40

Department

400274 CCRC

Work Shift

Range

UR URG 111

Compensation Range

$63,815.00 - $95,723.00

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.

Responsibilities:

The Clinical Project Manager assists with coordinating all aspects of multi-center clinical research trials in a Contract Research Organization (CRO) environment. This individual serves as a liaison with clinical trial sites to address protocol questions and relay study related information. Assists with development and execution of trial activities, including maintenance of study timelines and development of study related documents.

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

Schedule: 8:30 AM-5 PM

EOE Minorities / Females / Protected Veterans / Disabled:

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.

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Learn. Discover. Heal. Create.

Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.

If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals

At the University of Rochester, we commit to diversity, equity, and inclusion and united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.