[Hiring] Senior Clinical Trial Associate @Bausch+Lomb Companies Inc.

Role Description

Under the supervision of the Director, Clinical Operations / Sr. Clinical Trial Manager, responsible for supporting the implementation, conduct and closeout of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations.

• 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
  • 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 payments and 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.

Qualifications

• Bachelor’s degree in a health profession or science. Advanced degree a plus.
• At least 3 years of on-going 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).

Requirements

• This position may be available in the following location(s): US - Remote.

Benefits

• Starting pay for this role is between $85,000.00 and $115,000.00.
• U.S. based employees may be eligible for short-term and/or long-term incentives.
• Eligibility to participate in medical, dental, vision insurance, disability and life insurance.
• 401(k) plan and company match.
• Tuition reimbursement program (select degrees).
• Company holidays and well-being benefits.
• Eligible to receive sick time, floating holidays and paid vacation.