Clinical Research Associate II - MedTech

About the role

iqvia's MedTech division (MCRA) is looking for a Clinical Research Associate II in Washington. The role performs monitoring and site management so that study sites carry out the study and report data as required by the protocol, regulations, guidelines and sponsor requirements.

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
• 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 per GCP and local regulations
• Create documentation of monitoring visits, findings and action plans through visit reports, follow-up letters and other study documents
• Liaise with study team members; may support site recruitment plans and site financial management and invoice retrieval where applicable

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted
• At least 1 year of on-site monitoring experience
• Good knowledge of GCP and ICH guidelines and good therapeutic and protocol knowledge from company training
• Written and verbal communication skills with 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

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

The potential base pay range is $90,200 to $150,400 annually, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.