GENERAL PURPOSE:Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical data and is 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.RESPONSIBILITIES:
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately. Answers a broad range of data clarifications for each study, ranging from simple to complex. Fields complex inquiries from investigational, site, and study staff pertaining to study data, in conjunction with the CRDM when appropriate. Assists in audit preparation. Develops source data worksheets specific to each assigned study. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
Assists in conducting quality checks of data accuracy with data source records as assigned. Reviews medical records for prospective study participants in conjunction with study eligibility parameters to assist with enrollment.
Maintains study binders and filings according to protocol requirements and department policy. Prepares source documentation logs for review by trial investigators by extracting information from available source documents. Updates data and safety related information in OnCore. Maintains screening, enrollment, and other sponsor and/or protocol specific logs.
Assist in participant recruitment and retention
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required
Acts as a mentor to lower level staff. Provides general support and education to staff. Collaborates with leadership to develop and update training modules and educational opportunities specific to the data coordination team.
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR and department policies and procedures
Other duties as assigned
QUALIFICATIONS:Education:
Bachelor's degree required or equivalent combination of education and experience. Masters Degree preferred.
Minimum or 2 years clinical research experience or relevant work experience required.
Required knowledge, skills and abilities:
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 (verbal and written), and organizational skills;
Highly collaborative, works well in teams;
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet;
Fluent English language skills required (oral and written);
Ability to understand and follow standard research protocols and procedures.
CCRC or CCRP certification 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: $51,810 - $72,534 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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