RQM+ is hiring a
Senior Clinical Research Associate

Summary

Join RQM+ as a Sr. CRA to aid team members with administrative, logistical, and practical issues, including tracking and supervising the collection of ongoing study data.

Requirements

• Bachelor's Degree in scientific discipline or health care preferred
• Requires at least 4 years of year of on-site monitoring experience
• Equivalent combination of education, training and experience considered
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements
• Strong therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint required
• Written and verbal communication skills including command of English language
• Organizational and pragmatic problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites

Responsibilities

• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs
• Administer protocol, study specific documents and related study training to assigned sites
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol
• Manage the progress of assigned studies by tracking regulatory submissions and approvals
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF)
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
• Act as a mentor for clinical staff including conducting co-monitoring and training sign-off compliance visits
• Collaborate with study team members for project execution support as appropriate

Benefits

• Industry leading compensation package
• Deeply engrained focus on work life balance