Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Lead Clinical Research Associate - UBC

Company: United BioSource Corporation.
Location: Home-Based anywhere in US
Reference: REQ20011573
Closing Date: 25 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

POSITION SUMMARYMonitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs. Provides clinical project oversight and support as described under Essential Functions.ESSENTIAL FUNCTIONSThorough knowledge of sponsor specific project requirements, protocol and timelines.Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines.Maintains at least one active site per study assignment.Assists with project specific training. ...

Requirements:

POSITION SUMMARY

Monitors in accordance with ICH, GCP, CFR guidelines, UBC and project SOPs. Provides clinical project oversight and support as described under Essential Functions.

ESSENTIAL FUNCTIONS

  • Thorough knowledge of sponsor specific project requirements, protocol and timelines.
  • Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines.
  • Maintains at least one active site per study assignment.
  • Assists with project specific training.
  • Ensures appropriate CRA visit scheduling per protocol.
  • Tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks.
  • Maintains Q&A log for site and monitoring issues.
  • Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines.
  • Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager.
  • Attends client and project team meetings – assists with preparation, content and leading of meetings as required.
  • Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics.
  • Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction.
  • Coordinates EDC data entry, if applicable, and DCF resolution.
  • Coordinates site assignments in conjunction with Project Manager and Functional Manager.
  • Assists with other project specific tasks as delegated by Project Manager.
  • 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, departmental meetings and 1:1 with manager a minimum of monthly.
  • Responsible for content discussed during 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 with minimal corrections required.
  • Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS.
  • Consistently completes Call Log or Telephone Contact Report detailing communication with sites in a timely manner.
  • Completes Regulatory Binder and Investigational Product reconciliation.
  • Maintains regular contact with assigned sites per protocol.
  • Consistently completes expense reports within UBC timelines and 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:
    • = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently.
    • = Instruct how to conduct visit, report/letter writing and manage issues and actions.
    • = 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.
  • Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.).
    • Includes: Clinical Management Plan, Trip Report and Letter Templates, CRF Transmittal Form, Monitoring Worksheet, input for Monitoring Plan.

QUALIFICATIONS

  • Bachelor’s degree – Life Science preferred or equivalent industry and monitoring experience.
  • Minimum of > 24 months active monitoring.
  • Knowledge of medical terminology.
  • Good written and verbal communication skills.
  • Displays leadership, organizational and interpersonal 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.
  • Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable).
  • Thorough knowledge of ICH, GCP, CFR and UBC SOPs.
  • Up to 50% travel.

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.

*LI-AF1

Apply for this job: Lead Clinical Research Associate - UBC

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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.