Working Location: Nationwide Workplace Flexibility: RemoteJob DescriptionThe Clinical Research Associate (CRA) III is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of clinical trials. The CRA III ensures that clinical tasks are being performed in compliance with applicable regulatory standards, ICH-GCP Guidelines, and all applicable regulatory requirements and company policies and procedures.
Job Duties- 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.
Job QualificationsRequired:- 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 a proficiency with 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 which includes 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 details.
- 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:- Previous experience with medical device trials.
Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, 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, Fitness Center**
Connected Culture you can embrace:- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
