Clinical Research Associate I (SC4) in Tucson, AZ at Fast Switch - BHJOB13738_53056 GD
Company: Fast Switch
Posted on: June 16, 2019
Job ID: 53056Clinical Research Associate I. We are seeking a
Clinical Research Associate I--for a contract opportunity with our
Tucson, AZ client. Candidates must have experience working in a
clinical or doctor's office that actively participates in clinical
research studies sponsored by pharmaceutical, device, or diagnostic
companies. Or has experience working as a CRA/Monitor for a Pharma
or other clinical research organization (CRO).
- Responsible for the conduct of clinical study activities to
verify and validate new instrument platforms, assays and biomarkers
developed by the client, Medical Affairs.
- Works closely with study manager and other CRA staff to
complete all CRA functions associated with study planning,
implementation, monitoring and closing study conduct in accordance
with the principles of Good Clinical Practice (GCP).--
- Works closely with project managers, Medical Managers, and
Directors with project planning, implementation, and facilitating
Medical Affairs various types of non-registrational projects.
The following related tasks are fundamental to this position, but
they may be expanded or omitted at the discretion of the Study
Manager to more effectively complete clinical research and project
Site Management & Monitoring:
- Conducts in-house, and may independently perform on-site
monitoring in accordance with--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
- Manage study supply inventory and shipping.
- Conduct and assess site readiness and assist in creating site
- Work across multiple project teams, indications, and differing
- Assist in the creation of study materials (CRFS, operation
manuals, protocols, etc.).
- Assist in the creation of departmental operating procedures and
- Assists in the creation, management and independent execution
- Study training presentations for investigators and site
- Study supply ordering and shipping.
- Investigational product release, labeling, accountability at
- Site Readiness and Site Monitoring Plans.
- Assay transfer and assay qualification activities.
- Study records including paper and eTMF and electronic clinical
trial management system
- Site qualification, site initiation, routine monitoring and
close out visits and reports.
- Document compilation for clinical study reports and document
- 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.
- Bachelor of Science, RN, or BSN; OR equivalent combination of
education and experience.
- Familiar with FDA 21 Code of Federal Regulations 812 and
- 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.--
- Excellent skills in basic computer applications (Word, Excel,
- 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
- At least 1-2 years prior research experience in pharma, device,
or diagnostic research
- Prior experience with current Good Clinical Practices (cGCP)
and Code of Federal Regulations (CFR) preferred.
- A background in biomedical/healthcare services with laboratory
- Prefer local candidates only, but would consider someone
outside AZ, if they can relocate in a short time frame
- Proficient at managing multiple priorities and tasks
- Experience working in a pathology lab is a plus
- Willing to travel in the US and xUS. (30-60% travel; dependent
on project need)
To view all our open positions, please go to:
Keywords: Fast Switch, Tucson , Clinical Research Associate I (SC4) in Tucson, AZ at Fast Switch - BHJOB13738_53056 GD, IT / Software / Systems , Tucson, Arizona
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