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Senior Clinical Research Data Specialist
UR Ventures. Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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 trial 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.
- Assists in conducting quality checks of data accuracy with data source records as assigned.
- Perform data entry and verification tasks.
- Provides custom programming, statistical analysis, reporting and presentation graphics.
- Prepare and transfer data for analysis.
- Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics.
- Adheres to defined application development life-cycle practices, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
- Consults with user departments and sites to assess data preparation and management needs, program design and testing; package selection and use of systems, software and equipment.
- Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
- 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 leadership when appropriate.
- Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
- Assists in audit preparation.
- Develops source data worksheets specific to each assigned study.
- Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
- 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.
- Extracts and prepares drug safety profile information for annual reports.
- Prepares relevant information for DSMC reports as required and requested.
- Observes for deviations and acts to minimize them.
- Reports deviations when they occur, addressing adverse events with supervision.
- 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, Wilmot, and department policies and procedures.
Requirements
What you’ll need- Bachelor’s degree required
- 2 years of relevant experience required or equivalent combination of education and experience
- 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
- Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data 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
- Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
- CCRC - Certified Clinical Research Coordinator preferred or CCRP - Certified Clinical Research Professional preferred.
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account UR Ventures Website LinkedIn All Job Openings 11 - 50 employees 📚 Education 🤝 B2B 🔬 Science Education
- B2B
- Science UR Ventures is the innovation and commercialization arm of the University of Rochester, focused on advancing research and academic entrepreneurship. It connects university faculty and researchers with industry partners to facilitate the development of new technologies and businesses that can positively impact society. UR Ventures promotes collaboration, creativity, and knowledge transfer, thereby contributing to the university's mission of making the world ever better. Senior Clinical Research Data Specialist Job not on LinkedIn 🔥 3 minutes ago 🍂 Massachusetts – Remote 💵 $24 - $34 / hour ⏱ Part Time 🟠 Senior 🧪 Clinical Research Apply Now Find Hiring Managers Customize resume for this job Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- 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 trial 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.
- Assists in conducting quality checks of data accuracy with data source records as assigned.
- Perform data entry and verification tasks.
- Provides custom programming, statistical analysis, reporting and presentation graphics.
- Prepare and transfer data for analysis.
- Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics.
- Adheres to defined application development life-cycle practices, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
- Consults with user departments and sites to assess data preparation and management needs, program design and testing; package selection and use of systems, software and equipment.
- Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
- 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 leadership when appropriate.
- Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
- Assists in audit preparation.
- Develops source data worksheets specific to each assigned study.
- Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
- 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.
- Extracts and prepares drug safety profile information for annual reports.
- Prepares relevant information for DSMC reports as required and requested.
- Observes for deviations and acts to minimize them.
- Reports deviations when they occur, addressing adverse events with supervision.
- 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, Wilmot, and department policies and procedures. 🎯 Requirements
- Bachelor’s degree required
- 2 years of relevant experience required or equivalent combination of education and experience
- 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
- Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data 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
- Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
- CCRC - Certified Clinical Research Coordinator preferred or CCRP - Certified Clinical Research Professional preferred. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Clinical Research Coordinator III – RN 🕒 February 17 Thermo Fisher Scientific 10,000+ employees 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science Website LinkedIn All Job Openings Clinical Research Coordinator III supporting clinical research studies within a military clinic setting. Requires Maryland RN license and extensive experience in FDA-regulated trials. 🇺🇸 United States – Remote 💵 $38 - $44 / hour ⏱ Part Time 🟡 Mid-level 🟠 Senior 🧪 Clinical Research 🦅 H1B Visa Sponsor View More Clinical Researcher Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs
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Hard Skills & Tools
data managementdata entrystatistical analysisprogrammingdata workflow solutionsquality assurancedata verificationdata preparationdata reportingdata analysis
Soft Skills
attention to detailinterpersonal skillscommunication skillsorganizational skillsmentoringcollaborationproblem-solvingleadershipguidanceindependence
Certifications
CCRC - Certified Clinical Research CoordinatorCCRP - Certified Clinical Research Professional