Experienced Clinical Research Associate - Israel

About the role

IQVIA is looking for an experienced Clinical Research Associate in Israel to perform monitoring and site management work. The role ensures that sites carry out the study(s) and report study data as required by the protocol, applicable regulations and guidelines, and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and regulatory requirements such as GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan so that it matches project needs.
• Administer protocol and study training to assigned sites and keep regular contact to manage ongoing expectations and issues.
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate, and track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept in line with GCP and local regulations.
• Create and maintain documentation on site management and monitoring visits, including visit reports and follow-up letters.
• Liaise with study team members; may also support site recruitment planning and site financial management and invoice retrieval where applicable.

Required profile

• High school diploma or equivalent; a degree in a scientific discipline or health care is preferred.
• At least 2 years of on-site monitoring experience; an equivalent combination of education, training and experience may be accepted.
• Good knowledge of GCP and ICH guidelines, and good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.
• Organizational, problem-solving, time and financial management skills, and ability to build effective working relationships.

Required skills

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