Working Location:

Nationwide Workplace Flexibility:

Remote For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. \n\nEvery 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. \nOur 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.

Job Description 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. 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.\nParticipate in developing clinical study monitoring plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.\nProvide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports.\nProvide 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.\nWork on site qualification assessments and selection of countries and sites for study conduct.\nParticipate in and may facilitate cross-functional study teams, liaising with other functional areas to accurately coordinate clinical study activities.\nAssist 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.\nCreate and conduct training sessions, including investigator meetings and site training programs.\nParticipate 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.\nCoordinate 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.\nOversee and support Clinical Research Associates (CRAs) throughout the study lifecycle, from site identification through study close-out.\nCollaborate with sponsor affiliates and key opinion leaders (KOLs).\nMentor and train junior members of the clinical team.\nParticipate in preparing vendor requirements, defining project scope, and selecting study vendors; effectively manage interactions with vendor study teams.\nReview monitoring visit reports and collaborate with other CRAs and/or Monitors to identify quality trends or site issues and develop appropriate solutions. Job Qualifications\n

Required:

BA/BS or equivalent experience in scientific or healthcare disciplines.\nMinimum of five (5) or more years' experience in clinical research, with medical device and/or pharmaceutical trials.\nMinimum of three (3) or more years' experience in on-site clinical trial monitoring.\nStrong computer skills with a proficiency with MS Windows based applications.\nStrong 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.\nStrong interpersonal, communication and leadership skills\nFlexibility to accommodate changes in priorities and project needs.\nStrong organizational skills with attention to details.\nAbility to build and maintain positive relationships with management and peers.\nAbility to work independently and manage multiple tasks in a fast-paced environment.\nAbility to work effectively on cross-functional teams.\nValid driver's license required.\nAbility to travel domestically 20% - 40% of the time. Some international travel up to 10% may be required.

Preferred:

Previous experience with medical device trials.\nWhy join Olympus?\nWe 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\n
Center Valley, PA and Westborough, MA Are you ready to be a part of our team?

\nLearn 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\nWe 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 OCAAccommodations@olympus.com. 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.\nIt 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:

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Senior Clinical Research Associate