Clinical Operations Specialist I

Job Description

Job Description

Job Overview:

Pay Range: $35.00hr - $40.00hr

Requirement/Must Have:

• 2+ years of clinical research experience.

Responsibilities:

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines.
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices while partnering with internal stakeholders including clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups.
• Lead the execution of the device process and ensure continuous process improvement of efficiency and accuracy of procedures.
• Coordinate procurement of study inventory and manage shipment of devices to clinical sites within established timelines.
• Confirm receipt of study product at clinical sites and track product through to final disposition.
• Ensure required documentation is filed in the Trial Master File (TMF).
• Monitor internal device and study-specific inventory levels and support inventory forecasting and planning.
• Develop timeline assessments in collaboration with clinical stakeholders to meet key study milestones and deadlines.
• Generate transparency reporting data and reports as needed to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.
• Generate reports on outstanding invoice payments for clinical study team review.
• Ensure documentation is stored and archived appropriately within record retention facilities.
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive for multiple clinical research trials.
• Support clinical research laboratory operations as needed.
• Perform other incidental duties as assigned to support clinical study operations.

Nice to Have:

• Associate's or Bachelor's degree in a related field.

Skills:

• Clinical research.
• Process improvement.
• Trial Master File (TMF).
• Inventory management.
• Sunshine Act compliance.
• Invoice processing.
• Record retention.

Qualification And Education:

• Minimum of 2+ years of clinical research experience.

Benefits:

Our Benefits Include:

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Disclaimer : Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.