CRA II in Gaithersburg, MD at Apex Life Sciences

Date Posted: 8/6/2018

Job Snapshot

Job Description


We are seeking qualified candidates to join a leading Pharmaceutical company in a permanent role as a Clinical Research Associate II! 

Essential Functions:

  • Assist with the development of monitoring plans for assigned studies
  • Coordinate the distribution of supplies to study sites and assure an adequate quantity of supplies are on hand during the course of the study
  • Track distribution and return of all study materials and drug.
  • Conduct site initiation in order to ensure that all elements are in place for performing the study according to the protocol and in compliance with all applicable regulations and good clinical practice guidelines.
  • Perform interim site monitoring visits and document findings in a monitoring report which will be completed in a timely manner.
  • Conduct periodic telephone contacts to ensure that the study in progressing according to schedule and the site has all necessary materials to properly conduct the study.
  • Ensure adverse events and serious adverse events are being properly recorded and reported
  •  Perform close-out visits to all study sites. The close-out will entail accurate accountability of all study drug and material.
  • Develop and maintain Trail Master Files (TMFs) for assigned protocols and study sites according to the company SOPs.
  • Assist with the preparation of informed consent, case report forms (ICFs), study support documents (manuals, training tools, diary cards, source document worksheets) for assigned studies.
  • Reviews site generated ICFs for compliance with the study protocol and federal regulations.
  • Reviews data management documents (data management plans, coding plans, etc) for assigned studies.
  • Independently evaluate and recommend selection of investigators/study sites; participate in identification of potential sites.
  •  Independently train investigators, coordinator, and other trial staff in data collection methods to ensure collection of patient data that is accurate, complete, and conforms to project data standards and protocol requirements.
  •  Ensure the collection, review and updating of all essential documents defined by FDA regulations, company SOPs, and general industry standards.
  • Tracks enrollment at both the study and site levels for assigned studies against required projections; identifies and investigates enrollment issues and provide potential solutions to keep
  • Develop solutions for logistical and operational issues that arise during trials execution, and communicate these in a timely fashion to investigators, coordinator and company staff
  • Understand and apply clinical scientific research and knowledge of the drug development process, including significance of and differences between Phase I-IV clinical trial design, in all CRA activities.

Required Experience:

  • 2+ years of hands-on industry experience as a CRA (primarily as a monitor) within study trials
  • Experience working in Phase I-IV of clinical trials
  • Clinical Trial Documentation
  • Documentation Tracking and Maintenance
  • Monitoring experience
  • R.N. or B.S. in biological sciences or healthcare related field

Preferred Experience:

  • Work experience within therapeutic areas of oncology or cardiology
  • Work experience within a CRO

To apply to this position please send resume to 

Vickie Dagit



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.