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Contract Senior Clinical Research Associate, Oncology - RSS

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Primary Location: Morrisville, North Carolina, United States Additonal Locations: Austin, TX,USA; Carlsbad, CA,USA; Deerfield, IL,USA; San Francisco, CA,USA; San Juan Capistrano, CA,USA; Santa Clarita, CA,USA; Tampa, FL,USA; Valencia, CA,USA Full time R1208745

Job description

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 and reports
  • 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 trial materials.
  • 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 expectations.
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Other tasks and responsibilities as needed.

Skills/Competencies

  • 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 preferred.
  • Knowledge of pharmaceutical trials, terminology and practices.
  • Knowledge of FDA regulations and their practical implementation.
  • Strong verbal and written communication skills.
  • Able to motivate clinicians to complete accurate and time sensitive work.
  • 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.

Education:

  • Bachelor's (Required)

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 jobs.iqvia.com.

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 law.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.

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