Sr. Associate, Clinical Trial Management - CA in Irvine, CA at Apex Life Sciences

Date Posted: 5/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/15/2018
  • Job ID:
    849407

Job Description


Senior Clinical Trial Management Associate 

POSITION SUMMARY:

  • The Senior Clinical Trial Management Associate assists the Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies.
  • Depending on the experience of the incumbent, they may be assigned to manage a small study as a Clinical Trial Manager (CTM) or serve as a regional OSL on a global study. 
  • The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.
  • Other activities, special projects and assignments may be assigned as required.
  • As a result the percentage of time spent across key duties listed below for which the employee is responsible for or assisting with will vary . 
  • The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

KEY DUTIES / RESPONSIBILITIES:

The incumbent assists the CTM/OSL in all aspects of a clinical study(ies) including, but not limited, to the tasks specified below. 

  • Study Concept, Planning and Strategy Phase:
    • The incumbent is responsible to assist the CTM/OSL and FACT team with regional study feasibility, the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required. 
  • Study Initiation Phase:
    • The incumbent assists the CTM/OSL in region-specific document development including the:
      • informed consent forms;
      • regional investigator meetings/presentation of materials;
      • the development of regional enrollment initiatives;
      • and planning regional clinical study supplies.
    • They assist in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor. 
  • Study Management/Conduct Phase:
    • The incumbent assists the CTM/OSL in:
      • regional financial management;
      • database lock activities;
      • regional study drug management; regional trial master file management;
      • regional study enrollment management (e.g. contingency plan execution);
      • ongoing review of protocol deviations;
      • regional vendor management; and ensuring adverse event reporting. 
  • Close-Out Phase: 
    • The incumbent assists the CTM/OSL in the following activities:
      • supporting database lock activities;
      • ensuring all regional documents are filed in the TMF appropriately;
      • ensuring all close-out activities are completed;
      • ensuring study documentation is properly archived when the study is considered completed. 
    • The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. 

GENERAL: 

  • The incumbent is responsible for completing all required training to execute their job and maintain their training records.
  • They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate.
  • They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events.
  • In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file. 
  • The incumbent is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as policies, SOPs and Work Instructions.
  • Ongoing training in compliance areas and therapeutic specific knowledge is expected to maintain a solid knowledge base for performing assigned tasks. 

QUALIFICATIONS:

  • Science degree preferably in science or health-related field 
  • Previous experience of working on a clinical study 
  • Oversight or mentoring of more junior study monitors (direct or indirect) preferred 
  • Prior experience in device clinical research, ophthalmology and/or medical aesthetics a plus 

EXPERIENCE: 

  • In addition to the essential skills, the incumbent must have the ability to: 
    • Handle and prioritize multiple tasks simultaneously, 
    • Work effectively in a team/matrix environment, 
    • Understand technical, scientific and medical information, 
    • Handle conflict management and resolution, 
    • Understand clinical study budgets, 
    • Plan, organise, project manage and analyse data, and 
    • Demonstrate full competency in Microsoft Office programs. 

KNOWLEDGE: 

  • Employee must have a good understanding of the following: 
  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations), and 
  • Knowledge of concepts of clinical research and drug/device development 

  • Ability to travel up to 20% of time, domestically, for meetings as needed

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