This site uses cookies. To find out more, see our Cookies Policy

Country Study Specialist in South San Francisco, CA at Apex Life Sciences

Date Posted: 11/19/2018

Job Snapshot

Job Description


Duties: 

  • Development and/or writing study documents (protocols, protocol amendments, CRFs, investigational brochures, annual report, study guidelines, etc.)
  • Qualifying, monitoring and managing sites including co-monitoring with the CRO
  • Management of various CROs and vendors involved in the study (e.g. monitoring, data management, central labs, etc)
  • Implementation of operational activities and project management tasks associated with clinical studies (eg. central lab coordination, SAE tracking/reconciliation, etc.) to ensure they are conducted in a successful, timely manner and within budget
  • Responsible for all start-up activities including but not limited to: site selection, drug preparation, enrollment, data collection, etc.
  • Proactively identifying solutions when issues arise
  • Organization of investigator, steering committee, and data monitoring committee meetings
  • Assist with CRO and vendor identification and selection process
  • Management of key study parameters (e.g. start-up activities, drug preparation, enrollment, data collection, etc)
  • Implementation and management of operational plans
  • Data review (patient profiles, line listings, patient narratives, etc.)
  • Preparation of study updates
  • May take on timelines and budget management, as applicable

Skills: 

  • 4-5 years in the pharmaceutical industry including in-house experience
  • Solid, hands-on clinical trial experience including site monitoring
  • Strong organizational and oral and written communication skills
  • Solid experience developing/writing study documents (protocols, annual reports, etc.)
  • Ability to work as a team player and the ability to work in a fast-paced environment
  • Must be flexible, detail-oriented and have an interest in professional growth
  • Energetic, self-starter, able to multi-task and be proactive
  • Some travel required

Education: 

  • BS/RN degree or equivalent in the scientific or health care field (e.g. Nursing, Pharmacy, etc.)

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 844-463-6178.




915852