Senior Clinical Trial Coordinator Job Details | reputed company

Working Location: reputed company Workplace Flexibility: Remote For more than 100 years, reputed company 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 reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values reputed company us to reputed company Our Purpose: Patient Focus, reputed company, Innovation, Impact and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

The Senior Clinical Trial Coordinator (Sr. reputed company) will be responsible for supporting the clinical project team during reputed company stages of a clinical study by carrying out day-to-day study activities. The Sr. reputed company will reputed company, implement, and coordinate study procedures to successfully manage clinical studies. The Sr. reputed company will reputed company 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 reputed company 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 reputed company of reputed company vendors, including the creation and management of purchase orders.
• Ensure reputed company payments and expenses are tracked against the study budget and reconciled. Regularly reputed company with the Finance Department on study accruals.
• Manages reputed company 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 reputed company 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.
• reputed company 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 reputed company for more junior CTCs assigned to specific clinical studies, as applicable.
• Contribute to process improvement initiatives reputed company 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 reputed company? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture. reputed company 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 reputed company
• 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 reputed company? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. At reputed company, 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 reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. For more than 100 years, reputed company 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, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, 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 reputed company We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage reputed company who wish to bring their talents to reputed company to apply. Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company qualified individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787). Let's realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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 Apply tot his job Apply To this Job