RQM+ is hiring a
Senior Clinical Research Associate, Remote - United States

Summary

The job description is for a Senior Clinical Research Associate (Sr. CRA) at RQM+. The role involves conducting site monitoring visits, managing study progress, and ensuring compliance with regulatory requirements. The Sr. CRA will also act as a mentor for clinical staff and collaborate with team members.

Requirements

• Bachelor's Degree in scientific discipline or health care preferred
• Requires at least 4 years of year of on-site monitoring experience
• 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 and use of a laptop computer and mobile technology 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

• Aid the team members with administrative, logistical, and practical issues
• Track and supervise the collection of ongoing study data for regular project status reporting
• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Administer protocol, study specific documents and related study training to assigned sites
• Evaluate the quality and integrity of study site practices
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, diary and survey data and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
• 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
• Focus on work life balance