Clinical Research Coordinator - in house monitoring in Tucson, AZ at Apex Life Sciences

Date Posted: 10/2/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a CRA responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by a top device company. 

Responsibilities:

  • Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with internal Standard Operating Procedures, ICH GCP guidelines and Regulations.
  • Participates in assessing study risks.
  • Communicates on behalf of the study manager with investigators and site staff.
  • Prepares study performance reports and provides input into study budgets.
  • Preparation of study training presentations for investigators and site staff.
  • Study supply ordering and shipping.
  • Investigational product release, labeling, accountability at study sites.
  • Site Readiness and Site Monitoring Plans.
  • Assay transfer and assay qualification activities.
  • Study records including site and trial master files.
  • Site qualification, site initiation, routine monitoring and close out visits and reports.
  • Document compilation for clinical study reports and document archive activities.
  • Data management activities including user acceptance testing, data entry, and data verification as needed.:
  • Works within project teams to facilitate the conduct of standard study designs.
  • Participates in clinical affairs meetings and completes independent activities to support departmental functions.
  • Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training.
  • Adopts clinical practices that promote Quality First Time.

Qualifications:

  • Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.
  • 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience.
  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
  • A background in biomedical/healthcare services with laboratory experience preferred.
  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
  • Excellent writing and verbal communication skills.
  • Well organized and detail oriented.
  • Impeccable record keeping and filing skills.
  • Excellent time management skills.
  • Ability to give presentations and teach others.
  • Ability to work effectively in a team, and also work independently on assigned tasks
  • Must have experience with site visits, study binders and case report forms from previous experience with clinical study coordination or management, or clinical site monitoring.
  • Ability to complete intermittent overnight travel up to 30%.

***For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Clinical Research Coordinator AZ' in the subject line.

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.




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