GENERAL PURPOSE:

The Clinical Research Data Specialist II at the URCC NCORP Research Base Clinical Trials Network and Program is responsible for ensuring accurate, timely, and high-quality data collection for large multi-site cancer control and cancer care delivery clinical trials. URCC’s clinical trial portfolio includes prospective, cohort, longitudinal as well as Phase II – III randomized clinical trials. These trials will be conducted within the URCC NCORP Research Base clinical trial network, which is comprised of over 800 community oncology practices, and staffed by thousands of clinical research managers, coordinators, and oncology providers. Data for URCC clinical trials comes from electronic medical records, and other electronic data capture, software, and platforms. Our data includes physiological data, such as actigraphy, heart rate variability, functional and clinical tests, biospecimen, and images. Images may include MRI, and CT scans. Biospecimen data includes data from blood, saliva, stool, urine, and tissue.

This job requires a high degree of proficiency and accuracy with the ability to exercise independent judgment and the flexibility to vary specific tasks as needed. The candidate will work independently with cross functional teams such as Biostatistics, IT and Project Management– in order to set up and test databases; perform data quality checks; report on data collection and quality to multiple stakeholders; generate and monitor site level data queries; and ensuring complete, accurate, high-quality datasets for analysis.

The Clinical Research Data Specialist II also assists with oversight of undergraduate student employees. Using their advanced experience, they may also serve as a backup to the team manager, assists with the training and onboarding of new Clinical Research Data Specialists, and serves as a peer mentor and guide to less experienced Data Specialists.

JOB DUTIES AND RESPONSIBILITIES:

Data Processing and Quality Assurance for Ongoing Clinical Trials

• Performs a thorough review of a high volume of incoming site level research participant data for multiple assigned clinical trials. Assesses submitted data for timeliness, accuracy, and completion.

• Determines if data queries are necessary. Creates and sends Queries off- site coordinators for missing and incomplete data, and monitors for timely and complete responses.

• Leverages working knowledge of relevant federal regulations, policies, guidelines such as Good Clinical Practice (GCP), research protocols, SOPs and clinical trials data management best practices and laws to control and maintain accurate, high quality research data under secure conditions.

• Manages the collection, organization, and verification of study data in an electronic data capture system (REDCap) and scannable TeleformsTM. Tracks timely receipt of all required study documents from sites, such as signed consent forms, eligibility checklists, and case report forms (CRFs).

• Applies the details of the protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, and ensures proper source documentation (including medical notes and scans) has been received.

• Ensure receipt and data quality of Actigraphy, imaging, and other data received through TRIAD, Box, Powershare, and other data-sharing platforms.

Data Management Representation on Clinical Trial Teams

• Is an integral part of the study team for their assigned clinical trial projects. Works closely with Study Chairs, Project Managers, IT staff and biostatisticians to assist in planning, designing, testing, and implementation of electronic case report forms (REDCap) at the protocol development and activation stages, and ensures timely and correct set up of any additional data collection platforms required per protocol.

• Based on trial specifications, the Clinical Research Data Specialist II reviews REDCap codebooks to ensure consistent coding across study forms and across all URCC NCORP studies.

• Recognizes trends in data collection errors and suggests improvements in the flow of information, error detection/correction, etc.

• Assimilates and distributes information and data collected from multiple external sources in diverse formats. Manages bidirectional flow of information, analytical reports, feedback, and recommendations.

• Works closely with investigators and study personnel, as well as on-site study coordinators to develop appropriate data collection methods.

• Will perform data quality checks, for each assigned research project at the protocol development stage and throughout the lifecycle of the study. Serves as point person for communicating data status and trends and resolving any data issues for assigned projects.

• Provides the study teams with data collection packets and cover sheets for initial and ongoing protocol submissions and amendments.

• Responsible for supervision of Biospecimen Kit-Making.

• May assist the biostatistician with preparing for statisticalanalysis.

• Responsibilities may include processing research participant payments, depending on assigned research projects.

Data Management Team Leadership

• Assist with training and overseeing activities of new Clinical Research Data Specialists.

• Provides peer mentorship and guidance to more junior Data Specialists.

• Responsible for training and overseeing daily activities of approximately 3-6 undergraduate Data Management undergraduate student employees.

• Authors workflow processes, workflow process improvement, coverage documentation, etc.

• Leveraging their experience, the Data Specialist II proactively identifies opportunities for improvements for URCC NCORP Research Base data management policies, procedures, and workflows, and provides recommendations to meet URCC NCORP Research Base strategic goals.

• Participates in continuous learning and development to stay abreast in a rapidly changing field by attending trainings, educational opportunities, and professional development.

Other duties as assigned.

QUALIFICATIONS:

• Bachelor's degree and 2 years of relevant experience

• Or equivalent combination of education and experience required.

• Clinical research data management experience preferred.

• Working knowledge and/or training in REDCap, research data collection, electronic data capture, relevant federal regulations and guidelines for data monitoring and security, and data quality assurance preferred.

• Skill in completing assignments accurately and with attention to detail required.

• Ability to understand and follow standard research protocols and procedures required.

• Ability to process and handle confidential information with discretion required.

• Commitment to the University’s core values required.

• Ability to work independently and/or in a collaborative environment required.

• Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required.

• Strong interpersonal, communication, and organizational skills required.

• Highly collaborative, works well in teams required.

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

• Proficiency in medical terminology, ability to read and understand medical notes and clinical research data 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: $46,987 - $65,790 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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