Clinical Trial Associate - Bridgewater, United States - Ortho Dermatologics

Ortho Dermatologics

Verified Company

Bridgewater, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.

We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people's lives with our health care products.

Responsibilities:

Collaborates on and supports 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 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 postmarket studies
Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logístical management of followup and close out study visits to ensure compliance with protocols and GCP requirements
Assists in tracking study specific payments
Provides operational or workflow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
Collaborates on project teams, primarily with the Clinic, Research and Development, Advanced Development, Marketing, Regulatory and Quality/Compliance
Supports CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
Assists and supports CTM and clinical operations team in presentations of clinical information concerning specific projects
Works on projects of moderatetohigh 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 2 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 (mínimal).

Language and Verbal Skills

Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.

Analytical and Reading Skills

Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to assist in identifying problems, collecting data, draw valid conclusions, and report on findings.

Physical Requirements

While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel both domestically and internationally.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US.

Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $60k - $85k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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This position may be available in the following location(s): location_obj
Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected st