Clinical Research Associate I in Tucson, AZ at APEX Systems

Date Posted: 9/10/2019

Job Snapshot

  • Employee Type:
  • Location:
    Tucson, AZ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job #:  1006047
Apex Systems is looking for a Clinical Research Associate I in Tucson!  This position will work Monday – Friday during the day and will fill as soon as a qualified candidate is identified.
This is a great team to work with in this large company due to nature of the work and team members. Expand your resume and career with this professional team!
POSITION SUMMARY: All aspects of developing, implementing and closing Design Control Studies including verification and validation studies, and Clinical Studies conducted by Clinical Affairs involving instruments, software and reagents used in tissue-on-slide based in-vitro diagnostic tests.
- Assist with pre-study coordination and determination of readiness including record keeping for the following activities:
a) Study site management
b) Initiate Interactions with investigators and their staff on behalf of Ventana.
c) Protocol and Case Report Form Development.
d) Study supplies management.
e) Training investigators and their study team.
- In-house or on-site monitoring of studies including record keeping; May be required to travel intermittently up to 10%.
- Data base development and management including record keeping for the following activities:
a) Validation
b) Data entry
c) Data verification
d) Clarifications
e) Corrections
f) Preparation for analysis
- Study report reviews, writing, and compilation including record keeping.
- Participate on cross functional study teams.
- Monitor work to ensure quality, and continuously promote Quality First Time
Formal Training/Education:
Bachelor of Science OR equivalent combination of education and experience.
- 2+ years of previous pharmaceutical or medical device clinical study coordination or clinical study management experience required.
- Knowledge of current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
- A background in molecular biology/biochemistry with laboratory experience preferred.
Knowledge, Skills and Abilities:
  • 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
  • Ability to complete intermittent overnight travel up to 10%.

Manager’s Must Haves:

•Would be a good fit for a Clinical research coordinator or someone looking for additional experience in a sponsor environment.  Someone looking for In house CRA work, or someone who has been a regional monitor in the past and wants less travel, etc.  Or someone who wants to move into a monitor role, but doesn't yet have enough CRA experience.

•There is little monitoring experience available in this role, but there is some on site visit training potential and generally a less than 10% travel requirement.  Could be more dependent on project needs

•Would prefer at least 1-2 years prior research experience, in drug or device research.  

•Prefer local candidates only, but would consider someone outside AZ, if they could relocate in a short time frame 

•Previous experience with FDA/ICH/GCP 

•Self motivating and a team player

•Proficient at managing multiple priorities and tasks
Send your resume today to 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178-6178.