Job Description

About Client: A leading Pharmaceutical Manufacuring (Product) Brand

Work Location: Jersey City, NJ

POSITION SUMMARY:

• This position will report to Vice President Clinical Development. The Clinical Research Associate,
• will play a pivotal role in monitoring and managing late phase clinical trial sites to ensure compliance with study protocols and GCP.
• Must take ownership of trial management.

KEY ROLES AND RESPONSIBILITIES

• Site Monitoring Visits: Conduct initiation, monitoring, and close-out visits in line with GCP and ICH
• guidelines
• Quality Assurance: Assess site practices for protocol adherence and GCP compliance, escalating quality issues as needed.
• Reporting: Generate visit reports, follow-up letters, and other necessary documentation.
• File Management: Ensure that Trial Master File (TMF) is up to date
• Communication with investigators and investigative site staff
• Provide written and verbal status of site on study progress to the CTM

WORK EXPERIENCE:

• Minimum 3 years of experience in clinical monitoring, late phase trials are a plus
• Excellent communication skills, both written and verbal.
• Strong problem-solving and decision-making abilities.
• Ability to work cross-functionally with various stakeholders.
• Ability to frequent travel to visit sites across US.
• Ability to work virtually.

QUALIFICATIONS:

• Familiarity with medical terminologies, medical information reporting, and regulatory requirements.
• Managed and maintained medical data and systems.
• Excellent written and verbal communication skills
• Understanding of issues in medical information and medical review

EDUCATION:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.

CORE COMPETENCIES:

• Knowledge – medical terminology and regulatory requirements.
• Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Company’s products.
• Collaboration - ability to communicate across functions and at all levels in the organization.
• Compliance – understands industry regulations to maintain compliance.

if your profile matches with the job description, please do share a copy of your resume to gunjan.t@makonissoft.com at an earliest

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