What are the responsibilities and job description for the Clinical Research Associate position at Makonis?
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
