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Job Summary

Company
Luye Pharma Group​

Location
Princeton, United States​

Job Type
Contract (1 year)

Pay Rate
Competitive Salary

Years of Experience
Experienced(2-5 Years)

Job Reference Code
J2000808

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Clinical Trial Associate

Posted on Jan 20, 2021
Luye Pharma Group
Princeton, United States

About Company:

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of 40 drug candidates in China and more than 10 drug candidates overseas. Along with a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas under study in the U.S. and Europe, Luye Pharma has reached high-level international standards in advanced drug delivery technologies including microspheres, liposomes and transdermal drug delivery systems, as well as actively making strategic developments in the fields of innovative new compounds and antibodies, gene & cell therapies and smart formulations.


Job Profile:

The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Team. Responsibilities will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out). Candidate should have experience with insourced and outsourced studies. However, experience with Ph 1/2 insourced studies with focus on CNS, Hem/Oncology would be best suited for this role.


Job Details:
Responsibilities will include, but are not limited to, the following:
  1. Support the Study Team to select potential investigators and assess their interest in the study
  2. Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
  3. Track study progress in CTMS including patient enrollment and patient status update.
  4. Process drug shipments after gathering necessary essential documents and track the receipt of shipments
  5. Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. integration with newly eTMF, Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems,
  6. Support study data as the EDC administrator and by tracking CRFs and queries as appropriate
  7. Process and track payments to vendors and study sites as appropriate (This process is currently performed by the study managers)
  8. Have a significant role in managing the study documentation including responsibility for:
  9. distribute and, at times, create study documents for the study sites such as CDAs, feasibility questionnaires, study binders, etc.
  10. Oversight of regulatory documents for site initiation, Interim monitoring visits and close out visits.
  11. Creating and or reviewing study plans, specification documents, materials and tools (diary cards, visit assessment booklets, etc).
  12. Review documents including essential documents and submit documents to appropriate departments such as Regulatory Affairs, etc.
  13. Maintain and track documents such as IB, ML, insurance policies, documents that are expiring and IND safety letters using CTMS (or other tools)
  14. QC Collecting, quality review and submitting documents to the TMF and Performing of TMF as appropriate
  15. Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors
  16. Generate, finalize and distribute study team agendas and meeting minutes
  17. Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.
  18. Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc
  19. Provide access to systems when applicable. Track and ensure training of study team
Skills/Knowledge Required
  1. Completed BA/BS in directly relevant discipline or equivalent experience required
  2. At least 2 years’ experience as CTA (or comparable operating experience) in pharmaceutical, CRO, or healthcare environment(s) required
  3. Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus
  4. Computer skills - MS office suite
  5. CTMS (preferable Veeva Vault)
  6. Knowledge of databases (EDC, IVRS, Central Lab, Central IRB)
  7. Efficient at meeting planning / generating minutes
  8. Understanding / familiarity with drug development and process and Pharma
  9. Strong Verbal and written communications skills
  10. Self-starter / proactive
  11. Ability to work independently
  12. Good listener / problem solver
  13. Ability to prioritize and multi-task and demonstrate flexibility and attention to detail
  14. Familiarity with ICH / GCP and regulatory guidelines/directives
  15. Team player and ability to build relationships
  16. Strong organizational skills
  17. Proficient at Vendor / site payment process
  18. Knowledge of medical/scientific terminology
  19. Cross cultural awareness

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