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Job Details

Sr. Clinical Trial Specialist - UBC

Company: United BioSource Corporation.
Location: Kansas City, MO
Reference: REQ20012313
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

POSITION SUMMARYThe CTS performs investigative site recruitment/feasibility reviews, project training, remote clinical data monitoring and resolution, progress status tracking, site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. ...

Requirements:

POSITION SUMMARY

The CTS performs investigative site recruitment/feasibility reviews, project training, remote clinical data monitoring and resolution, progress status tracking, site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements.  Performs essential document collection and review for site start up and initiation in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and documentation protocol. 

The Sr. CTS must demonstrate the ability to lead and mentor CTS staff, take on higher level tasks as delegated by the Project/Functional Manager and escalate and mitigate risk as appropriate, in addition to the responsibilities of the CTS.

ESSENTIAL FUNCTIONS

  • Coordinate and implement regulatory and Institutional Review Board (IRB) activities as required in the management of site clinical trials research involving the collection, documentation and compilation of research data.
  • Ensure compliance with safety regulations by evaluating the consistency, quality and timeliness of serious adverse event reporting.
  • Responsible for site management activities to ensure compliance with subject informed consent, right and privacy requirements; in the evaluation of subject population, facilities, staff and qualifications.
  • Evaluate, guide and train site staff on protocol and regulatory compliance /  requirements.
  • Provide in-house and vendor system training and access.
  • Execute confidentiality agreement, contract and budget negotiations.
  • Create, evaluate, manage and preserve Trial Master Files (TMF) and essential documents in compliance with FDA, ICH/GCP regulations and local laws.
  • Prepare, package and archive SMF/TMF at study closure.
  • Ensure regulatory authority compliance and client audit readiness of TMF.
  • Review, verify accurate and timely submission of electronic data entry of study subject information.
  • Ensure protocol deviations are reported to IRB as appropriate.
  • Conduct remote monitoring visits and complete site reports.
  • Ensure sites meet contractually required enrollment obligations.
  • Facilitate payment distribution of investigator sites through the evaluation of contractual milestone achievements.

QUALIFICATIONS

  • BA/BS or relevant working experience.
  • 0 – 2 years experience with Bachelor degree.
  • 6 – 8 years relevant work experience in clinical research/health related industry preferred.
  • Excellent written and verbal communications skills required.
  • Strong Microsoft Office skills (Outlook, Word, Excel) required.
  • Aptitude in learning new computer systems required.
  • Ability to demonstrate broad and comprehensive knowledge of theories, concepts, practices and policy with the ability to use them in complex and/or unprecedented situations across multiple functional areas.
  • Flexibility and ability to multitask required.
  • Basic medical terminology or knowledge desired.
  • Ability to lead operational initiatives to meet or exceed customer service standards and expectations in assigned site(s) and/or across multiple areas in a timely and respectful manner.

ABOUT THE DEPARTMENT

United BioSource Corporation (UBC), a subsidiary of Express Scripts, is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
 

While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use. 

Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.

UBC aligns with Accredo and CuraScript SD, also part of the Express Scripts family, to provide best-in-class, integrated services.

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.

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Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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