Express Scripts UBC - Sr Clinical Research Associate in Kansas City, Missouri
Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs
- Bachelor’s degree required.
- Minimum of 2 years of active monitoring.
- Thorough knowledge of medical terminology.
- Good written and verbal communication skills.
- Consistently meets or exceeds metrics for quality trip reports and letters.
- Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation.
- Ability to perform tasks in CTMS, EDC, Outlook and client specific systems (if applicable).
- Thorough knowledge of ICH, GCP, CFR and UBC SOPs.
- Up to 80% travel.
- Thorough knowledge and application of project specific protocol.
- Consistently completes on site monitoring in accordance with project specific timelines.
- Consistently completes travel scheduling in accordance with project specific and UBC guidelines.
- Attends project team meetings, department meetings and minimum of monthly 1:1 with manager. responsible for content of these meetings
- Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs.
- signs, scans and/or provides to CSS/RDS for filing in Trial Master File according to UBC and/or sponsor timelines requiring minimal corrections.
- Ensures follow-up of site issues and action items per UBC/sponsor timelines.
- Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS.
- Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol.
- Monitors within EDC data entry, if applicable, and assists sites with DCF resolution.
- Completes Regulatory Binder and Investigational Product reconciliation.
- Maintains regular contact with assigned sites per study requirements.
- Consistently submits expense reports within UBC timelines.
- Consistently follows UBC Travel Guidelines.
- Consistently completes SOP review and documentation within requested timelines.
- Consistently completes sponsor specific training and documentation within requested timelines.
- Assists PM and management team by being an AIM leader.
- A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently.
- I = Instruct how to conduct visit, report/letter writing and manage issues and actions.
- M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit.
- Assists management team by mentoring other CRAs.
- Assists with preparation and/or delivery of presentations for UBC Academy, departmental training and/or sponsor specific training.
ABOUT THE DEPARTMENT
Do you enjoy making things work seamlessly and figuring out ways to improve functionality? Do you have a knack for automating processes? Be a part of our team that focuses on reliability and keeping our systems running. From data centers to servers, this talent is relied on to create and maintain critical platforms for the organization. If this is your skill set and you want to be at the center of work that impacts 83 million Americans, explore our opportunities.
ABOUT EXPRESS SCRIPTS
Advance your career with the company that makes it easier for people to choose better health.
Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the "Most Admired Companies" in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.
Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.