Senior Clinical Research Associate

Working Location: Nationwide. Workplace Flexibility: Remote.

About the role

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.

Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) in compliance with the study-specific Clinical Monitoring Plan, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable government regulations and guidelines.
• Participate in developing clinical study monitoring plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.
• Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports.
• Provide regular updates on study progression; proactively identify and resolve issues that arise during study conduct; and manage escalation of study-related issues to the Clinical Project Manager and/or the Global Lead.
• Work on site qualification assessments and selection of countries and sites for study conduct.
• Participate in and may facilitate cross-functional study teams, liaising with other functional areas to accurately coordinate clinical study activities.
• Assist in the development of appropriate Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with ICH-GCP guidelines and company SOPs/WIs for clinical studies.
• Create and conduct training sessions, including investigator meetings and site training programs.
• Participate in study audits, as applicable, including providing guidance at the site and project levels toward audit readiness standards and supporting preparation for audits and required follow-up actions.
• Coordinate with Regulatory Affairs and Medical Safety teams to track and monitor the reporting of adverse events, including conducting risk assessments, mitigation activities, and contingency planning as required.
• Oversee and support Clinical Research Associates (CRAs) throughout the study lifecycle, from site identification through study close-out.
• Collaborate with sponsor affiliates and key opinion leaders (KOLs).
• Mentor and train junior members of the clinical team.
• Participate in preparing vendor requirements, defining project scope, and selecting study vendors; effectively manage interactions with vendor study teams.
• Review monitoring visit reports and collaborate with other CRAs and/or Monitors to identify quality trends or site issues and develop appropriate solutions.

Requirements

• BA/BS or equivalent experience in scientific or healthcare disciplines.
• Minimum of five (5) or more years’ experience in clinical research, with medical device and/or pharmaceutical trials.
• Minimum of three (3) or more years’ experience in on-site clinical trial monitoring.
• Strong computer skills with proficiency in MS Windows-based applications.
• Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials, including applicable ISO regulations for any trials conducted globally.
• Strong interpersonal, communication, and leadership skills.
• Flexibility to accommodate changes in priorities and project needs.
• Strong organizational skills with attention to detail.
• Ability to build and maintain positive relationships with management and peers.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Ability to work effectively on cross-functional teams.
• Valid driver’s license required.
• Ability to travel domestically 20% - 40% of the time. Some international travel up to 10% may be required.

Preferred Qualifications

• Previous experience with medical device trials.

Benefits

• Competitive salaries, annual bonus, and 401(k) with company match.
• Comprehensive medical, dental, and vision coverage effective on start date.
• 24/7 Employee Assistance Program.
• Free live and on-demand wellbeing programs.
• Generous paid vacation and sick time.
• Paid parental leave and adoption assistance.
• 12 paid holidays.
• On-site child daycare, café, and fitness center (locations vary).
• Paid volunteering and charitable donation/match programs.
• Employee Resource Groups.
• Dedicated training resources and learning & development programs.
• Paid educational assistance.

Pay

The anticipated base pay range for this full-time position is $100,263.00 - $135,355.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the national average and may vary depending on the location of the individual.