Senior Clinical Trial Coordinator

Req ID: 10012

Working Location: NATIONWIDE

Workplace Flexibility: Field

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.

Job Description

The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting the clinical project team during all stages of a clinical study by carrying out day-to-day study activities. The Sr. CTCwill develop, implement, and coordinate study procedures to successfully manage clinical studies. The Sr. CTC will perform diverse duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study-specific documents.

Job Duties

Act as the Subject Matter Expert and primary point of accountability and reconciliation for the Trial Master File (TMF) and the Investigator Site File (ISF).
Manages the tracking, review, and collection of study-specific documents required in the site’s Regulatory Binder.
Assist in tracking study activies and milestones by managing and maintaining study tackers and logs.
Manages device accountability for clinical studies, including tracking, shipment, and reconciliation of devices.
Administrative oversight of current vendors, including the creation and management of purchase orders.
Ensure all payments and expenses are tracked against the study budget and reconciled. Regularly interface with the Finance Department on study accruals.
Manages all aspects of study-specific payments (e.g., vendors, investigational study sites) in accordance with executed agreements and approved budgets.
Provides agendas, meeting minutes, and action items for project team meetings.
Maintains Sunshine Act Reporting records for assigned studies and reports timely updates to the Olympus Transparency Reporting Team and helps to reconcile any issues.
Supports literature search activities as required.
Ensures data quality by reviewing completeness and accuracy of study data, including facilitating the resolution of data queries under the guidance of the Clinical Research Associate (CRA), Data Management and/or the Clinical Project Manager to ensure compliance with specified study protocols.
Oversee the design, development, and maintenance of clinical study tracking in the Project Plan Management Tool and provides routine reports/dashboards to study team members.
Provides guidance, mentorship, and daily oversight for more junior CTCs assigned to specific clinical studies, as applicable.
Contribute to process improvement initiatives within clinical operations.
May participate in co-monitoring visits or other site visits based on experience and training provided by and under the guidance of the assigned CRA or assigned CPM.
Maintain audit readiness of study documentation, and assisting with audit and inspection preparation, ensuring compliance with GCP, ICH and company standards.
Other responsibilities as assigned.

Job Qualifications

Required:

BA/BS or equivalent experience in scientific or healthcare disciplines.
Minimum of two (2) or more years experience in clinical research, with medical device and/or pharmaceutical trials.
Strong computer skills with proficiency with MS Windows-based applications.
Working knowledge of ICH Good Clinical Practice guidelines.
Excellent communication skills (oral and written).
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.
Ability to travel domestically up to 10%.

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 working at this location is $58,238.00 - $78,621.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). 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 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.

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

Job Segment: Business Process, Inspector, Management, Quality

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