Clinical Research Associate, Sponsor Dedicated

About the role

iQvia is looking for a Clinical Research Associate (CRA) dedicated to sponsor projects in Durham. The CRA performs monitoring and site management work so that sites run their studies correctly and report study data as required by the protocol, regulations, guidelines and sponsor requirements. Candidates must live in the same country as the job.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) under the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to make it more predictable.
• 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 kept according to GCP and local regulations.
• 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 planning 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.
• At least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor or similar setting.
• Good knowledge of clinical research regulations, including GCP and ICH guidelines.
• Written and verbal communication skills with a good command of English.
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships with coworkers, managers and clients.

Required skills

• EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems.
• Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.

The potential base pay range, annualized, is $74,500 to $197,500, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.