Senior Clinical Trial Associate

Bausch + Lomb; San Juan (PR); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401(k) plan and company match

Tuition reimbursement program

Company holidays

Well-being benefits

Paid sick time and vacation

Job summary

Bausch + Lomb is seeking a Clinical Operations professional to assist the Director and Sr. Clinical Trial Manager in implementing and closing out clinical studies.

The role covers protocol development, site coordination, TMF structure, regulatory submissions, and cross-functional collaboration. The candidate will support study conduct, monitoring, and administrative tasks, ensuring adherence to GCP and FDA requirements while coordinating with multiple teams and trial sites.

Qualifications

• Bachelor's degree in health profession or science; advanced degree a plus.
• At least 3 years of ongoing clinical trials experience.
• Strong knowledge of GCPs and FDA regulatory requirements.
• Knowledge of medical terminology.

Responsibilities

• Support CTM/Sr. CTM on clinical planning, protocol and CRF development, IRB submissions, site selection and TMF prep.
• Assist in study conduct, monitoring, and close-out activities to ensure GCP compliance.
• Track study payments and invoices; provide workflow support for systems and procedures.
• Collaborate with R&D, Regulatory, Safety and Quality teams on projects.
• Prepare administrative documents for study programs, TMFs and start-up activities.
• Assist in presentations of clinical information for projects.

Skills

GCP knowledge

FDA regulatory knowledge

Communication skills

Independent work

Medical terminology

Education

Bachelor's in health science

Advanced degree a plus

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Objectives:

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.

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

Requirements:

• Bachelors 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).

This position may be available in the following location(s): [[location_obj]]

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $85,000.00 and $115,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

• U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

Our US Benefit Programs:Employee Benefits: Bausch + Lomb (https://www.bausch.com/careers/benefits/).

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.