Working Location: Nationwide
Workplace Flexibility: Remote
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.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers.
The 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.
- 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.
Required:
- 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
**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.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
You Belong at Olympus
We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs
