Biostatistics Lead guiding statistical strategy for clinical development at Sanofi. Overseeing data integrity and analytics in pharmaceutical research with a focus on innovative treatments.
About the role
- Data Coordinator for WV Clinical and Translational Science Institute responsible for data support in clinical trials. Perform data entry, phlebotomy duties, and collaborate with research staff.
Responsibilities
- Assist with the collection, entry, and organization of clinical data
- Appropriate entry in various Electronic Data Capture Systems
- Collaborate with study staff to ensure appropriate data is collected and field questions regarding clinical data forms
- Actively prepares for and participates in monitoring and auditing activities
- Ensure queries are resolved in a timely manner in accordance study requirements
- Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events
- Utilizes Clinical Trial Management System (CTMS) to enter appropriate research documents and update participant information.
- Access and utilizes the Electronic Medical Records (EMR) for various data needs related to studies
- Assist study staff with scheduling and attending participant visits to collect appropriate and relevant data
- Assist with preparing, processing, collecting and shipping specimens/samples accurately under well-defined requirements
- Complies with the International Air Transport Association and institutional policies for shipping and receiving biological specimens, and devices
- Create and manage phlebotomy research kits; ensure quality control
- Assists and/or follows direction of management to determine the best course for customer service
- Communicates with investigators, coordinators, and sponsors by email, telephone or in-person. Perform basic measurements and venipuncture on participants according to protocol after appropriate training
- Duties also include assisting with receiving, handling, storage, and shipment of samples.
- Schedule and/or call subjects for appointments; contact participants with reminders or other requirements.
- Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility and adheres to industry and government standards.
- Assists and/or follows direction of management to determine the best course for customer service.
- Communicates with investigators, coordinators, and sponsors by email, telephone or in-person.
Requirements
- Associate's degree
- A minimum of two (2) years of experience in research, clinical support; or working in a clinical setting.
- Strong problem-solving, risk assessment and impact analysis abilities.
- Strong work processing skills and understanding and the ability to handle stress and work under pressure.
- Strong time management skills and ability to prioritize and manage multiple projects simultaneously.
- Computer proficiency and familiarity with use, including Microsoft Office
- Demonstrated ability to work effectively in both cross-functional teams and independently is required.
- Ability to effectively present information and respond to questions from groups of managers, clients, and co-workers.
- General knowledge of medical terminology
- Skilled at phlebotomy
- Ability to travel with WV CTSI Mobile Clinical Trial Unit with occasion overnight stays within West Virginia
Benefits
- 37.5-hour work week
- 13 paid holidays
- 15 annual leave (vacation) days per year
- 18 sick days per year
- WVU offers a range of health insurance and other benefits
- 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks.
- Wellness programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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