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Clinical Trial Management with Study Start-Up Experience
Ref No.: 18-00662
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 06/04/2018 to 05/31/2019
CLINICAL TRIAL MANAGEMENT WITH STUDY START-UP EXPERIENCE
IRVINE, CA


Project Description:
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 Client policies and procedures.
  • 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.
  • 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 Client's 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.

Required Skills:
  • Candidates with experience the following a plus: - medical device clinical trials - ophthalmology - dermatology/ medical aesthetics - global clinical trials (Canada and US regions) Experience in study startup preferred.
  • 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.
  • 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, organize, project manage and analyze data.
  • Demonstrate full competency in Microsoft Office programs.
  • 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.
  • Knowledge of concepts of clinical research and drug/device development.
  • Ability to travel up to 20% of time, domestically, for meetings as needed.

This 11+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00662
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE