Senior Clinical Trial Operations Specialist

Bausch + Lomb; Montpelier (VT); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Tuition reimbursement

Paid vacation and holidays

Job summary

Bausch + Lomb in the United States is seeking a Clinical Trials Specialist to support the design, conduct, and closeout of studies in compliance with the Investigational Plan and GCP.

Under the Director, Clinical Operations, you will assist with protocol development, site selection, TMF management, and regulatory submissions while coordinating with cross-functional teams to ensure study quality and timely execution.

Qualifications

• 3+ years of ongoing clinical trials experience.
• Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
• Knowledge of medical terminology.
• Ability to effectively work independently.
• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook).
• Travel may be required (minimal).

Responsibilities

• Collaborates and supports CTM/Sr. CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training
• Supports CTM/Sr. CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies
• Supports CTM/Sr. CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
• Assists in tracking study specific paymentsand invoices
• Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
• Collaborates on project teams, primarily with Research and Development, Regulatory, Safety, and Quality/Compliance
• Supports CTM/Sr. CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
• Assists and supports CTM/Sr. CTM and clinical operations team in presentations of clinical information concerning specific projects
• Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised

Skills

GCP knowledge

FDA regulations

Medical terminology

Independent worker

Communication skills

Education

Bachelor's degree in health/science

Advanced degree a plus

Job description

Bausch + Lomb in the United States is seeking a Clinical Trials Specialist to support the design, conduct, and closeout of studies in compliance with the Investigational Plan and GCP.

Under the Director, Clinical Operations, you will assist with protocol development, site selection, TMF management, and regulatory submissions while coordinating with cross-functional teams to ensure study quality and timely execution.