Clinical Research Data Spec I

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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:

400119 Surgery-Cancer Control

Work Shift:

UR - Day (United States of America)

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

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:

Assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting. Answers simple data clarifications (i.e. data queries) for each study.

GENERAL PURPOSE:

The Clinical Research Data Specialist I is responsible for data validation and data management activities for large, national clinical trials run through the URCC NCORP Research Base network consisting of over 800 clinical research sites. Under oversight of the Sr. Clinical Research Data Manager, the Clinical Research Data Specialist I will be responsible for checking data for completion and confirming data accuracy compared to source documents. The role will also be responsible for communicating with off-site coordinators to correct data in compliance with Good Clinical Practice standards, and managing data in REDCap and Access for multiple clinical trials. The work performed requires a high degree of accuracy and attention to detail, the ability to exercise some independent judgement, and flexibility to vary specific tasks as needed. This work also requires strict adherence to HIPAA requirements, and federal, University and URCC NCORP Research Base data quality assurance and quality control standards. Requires collaboration with other research team personnel (investigators, project managers, on-site coordinators). This position is fully in person during regular business hours in Rochester New York with no possibility for remote work.

RESPONSIBILITIES:

Logs in and performs thorough review of high-volume incoming research data for multiple studies for accuracy and completeness, and determines if data queries are necessary. Queries off-site coordinators for missing and incomplete data.

Performs thorough examination of all data entered into Access and REDCap databases for clarity and accuracy.

Working closely with investigators, designs/creates scannable (TeleformTM) versions of study questionnaires. Troubleshoots areas of common incomplete and faulty data and suggests improvements in flow of information, error detection/correction, etc.

Assists in designing/preparing study packets for patients, data submission cover sheets, and other study-related items as necessary, e.g., pharmacy manuals, training manuals.

Prepares, ships, and tracks study supplies to multiple off-site locations.

Works closely with investigators and study personnel, as well as on-site study coordinators to develop appropriate data collection methods for each research project. Analyzes and suggests improvements in flow of information, error detection/correction, etc.

Creates electronic data tracking forms and electronic participant charts.

Other duties as assigned

QUALIFICATIONS:

Associate's degree and 1 year of relevant experience

Or equivalent combination of education and experience required

Bachelor's degree preferred

Required:

Skill in completing assignments accurately and with attention to detail

Ability to process and handle confidential information with discretion

Commitment to the University's core values

Ability to work independently and/or in a collaborative environment

Understands and follows data integrity standards and processes

Strong interpersonal, communication, and organizational skills

Highly collaborative, works well in teams

Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet

Preferred:

Ability to understand and follow standard research protocols and procedures

Knowledge of medical terminology

Good communication and organizational skills

the ability to exercise independent judgment

attention to detail.

Ability to handle several projects simultaneously, prioritize and shift priorities quickly.

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.