Oncology Clinical Research Associate (CRA 2), Sponsor Dedicated

About the role

iQVIA is hiring Clinical Research Associates (CRA) at levels 1 and 2, including an Oncology CRA 2 dedicated to a sponsor. The role covers monitoring and site management so that sites run studies and report data as required by the protocol, regulations and sponsor requirements. Candidates need 6 months to 2 years of onsite monitoring experience in oncology, with a preference for cardiovascular/renal/metabolic and/or neurology, and can be located anywhere in the US.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) following the contracted scope of work and GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• Administer protocol and study training, keep regular contact with sites and escalate quality issues.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is maintained under GCP/ICH and local rules.
• Create documentation of site management, monitoring findings and action plans through visit reports, follow-up letters and other study documents.
• Liaise with the study team; may support the start-up phase, site recruitment plans and site financial management and invoice retrieval.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted.
• 6 months to 2 years of onsite monitoring experience in oncology; some organizations require CRA training or prior monitoring experience.
• Basic knowledge of GCP and ICH guidelines, and good therapeutic and protocol knowledge from company training.
• Good command of English, written and verbal communication, organizational and problem-solving skills, and effective time and financial management.

Required skills

• Microsoft Word, Excel and PowerPoint
• Use of a laptop, iPhone and iPad where applicable

The potential base pay range, annualized, is $71,900 to $182,000, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.