Senior Clinical Research Associate, Sponsor Dedicated

About the role

iQvia is looking for a Senior Clinical Research Associate, Sponsor Dedicated, based in Carlsbad. The role performs monitoring and site management work so that study sites carry out the study 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 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 query generation and resolution; may support the start-up phase.
• 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 study team members; may also support 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 3 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.

Required skills

• Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.
• Organizational, problem-solving, time and financial management skills.
• Ability to build effective working relationships with coworkers, managers and clients.

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