Clinical Trial Management Associate in Foster City, CA at Apex Life Sciences

Date Posted: 3/26/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Management
  • Experience:
    At least 1 year(s)
  • Date Posted:
    3/26/2018
  • Job ID:
    817258

Job Description


Essential Duties And Job Functions

• Under supervision serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of company, collaborative, Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs

• Under supervision may serve as the key operational contact for company studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs

• May take part in fair market evaluations ISRs in collaboration with Clinical Pricing department

• May participate in coordination and input to periodic safety update reports and development safety update reports when requested

• Communicates and collaborates with Medical Affairs, Clinical Research, Regulatory Affairs, CCF, Clinical Supply Management, and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities

• Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track

• Supports study drug planning and shipping activities

• Ensures all protocol, budget, contract are appropriately approved, executed, and documented.

• Forecasts, tracks and reports CO and ISR milestones and ensures invoice payment.

• Provides monthly study updates to the appropriate internal stakeholders.

• Maintains internal Clinical Operations databases and document repositories

• Must be familiar with routine medical/scientific terminology

• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision

• Assists in preparation of safety, interim and final study reports, including resolving data discrepancies

• Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports

• May contribute to SOP development

• For company studies, may monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required

• May resolve routine monitoring issues

• Travel may be required

• Responsible for the oversight and management of investigator-sponsored and collaborative studies

Knowledge, Experience And SkillsKnowledge

• Excellent verbal, written, interpersonal and presentation skills are required

• Knowledge of FDA and/or EMA Regulations (or relevant local regulations) , ICH Guidelines, and GCP governing the conduct of clinical studies

• Working knowledge and experience with Word, PowerPoint and Excel

Experience And Skills

• At least 1+ year of relevant experience and a BS or BA in a relevant scientific discipline or

• At least 1+ year of experience and an RN (2 or 3 year certificate)

To apply for this position please send resume to:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com  

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.