Contract Senior Clinical Research Associate, Oncology - RSS
Company: IQVIA Holdings Inc
Location: Santa Clarita
Posted on: June 12, 2021
Seeking a Clinical Research Associate with oncology experience
for a contract opportunity. Limited travel. Home-based!
The Clinical Research Associate will oversee the execution of
clinical trials. The Clinical Research Associate will establish
trial sites, train site staff, manage investigational drugs and
trial materials, monitor clinical trial data and resolve queries.
You will conduct regular site visits, liaise with and encourage all
stakeholders at clinical trial sites. You will play a leading role
in generating and overseeing documentation and records for patients
in the clinical trials. To be successful in this role, you should
be able to recognize site problems and initiate appropriate
solutions. Ideal candidates will be detail-oriented, have
significant oncology trial experience, and have the ability to
multitask and be able to collaborate with all.
GENERAL DUTIES AND ESSENTIAL JOB FUNCTIONS:
- Identifying, evaluating and establishing trial sites, and
closing sites down.
- Collecting completed CRFs and source data in electronic form
and establishing practical timelines for CRF completion.
- Verifying that data entered on to the CRFs is consistent with
patient clinical records (source data/document verification).
- Receiving queries on CRF's, working with trial sites to quickly
and accurate resolution of queries
- Writing visit reports and file and collate trial documentation
- Training site staff on protocol requirements, proper source
documentation and case report form completion.
- Establish appropriate communication with ethics committee
regarding rights, safety and well-being of trial subjects.
- Ordering, tracking, and managing investigational drugs and
- Overseeing and documenting investigational drug dispensing,
inventory and reconciliation.
- Protecting subjects' confidentiality, updating their
information, and verifying investigational drug has been dispensed
and administered according to protocol.
- Conducting regular site visits, coordinating project meetings
and writing visit reports.
- Implementing action plans for sites not meeting
- Ensuring compliance with SOPs and local regulations, and ICH
and GCP guidelines.
- Other tasks and responsibilities as needed.
- Bachelor's degree in Nursing, Biological Science or a related
field. Advanced degrees preferred.
- 5+ years experience as a Clinical Research Associate.
Experience with oncology medicine and trials strongly
- Knowledge of pharmaceutical trials, terminology and
- Knowledge of FDA regulations and their practical
- Strong verbal and written communication skills.
- Able to motivate clinicians to complete accurate and time
- Proficient computer skills, particularly with electronic data
capture (EDC) software systems.
- Ability to manage and prioritize workload effectively.
- Available to travel extensively and on short notice, and
ability to manage travel schedules, such as flight schedules.
- Valid driver's license, proficient driving skills, own reliable
transport and up-to-date car insurance.
At IQVIA, we believe in pushing the boundaries of human science
and data science to make the biggest impact possible - to help our
customers create a healthier world. The advanced analytics,
technology solutions and contract research services we provide to
the life sciences industry are made possible by our 70,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, status
as a protected veteran, or any other status protected by applicable
IQVIA, Inc. provides reasonable accommodations for applicants
with disabilities. Applicants who require reasonable accommodation
to submit an application for employment or otherwise participate in
the application process should contact IQVIA's Talent Acquisition
team at firstname.lastname@example.org to arrange for such an
Keywords: IQVIA Holdings Inc, Santa Clarita , Contract Senior Clinical Research Associate, Oncology - RSS, Other , Santa Clarita, California
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