Clinical Research Associate – reputed company reputed company
Job Description:
- Conduct site monitoring visits (initiation, routine, and reputed company-out) to ensure compliance with the clinical protocol, GCP, and regulatory requirements.
- Assist in the preparation and review of essential trial documents, such as informed consent forms, case report forms, and investigator brochures.
- Collaborate with site staff to ensure proper documentation, timely data entry, and resolution of data queries.
- Assist in the identification, selection, and training of investigative sites.
- Maintain accurate and complete study files and records in accordance with GCP and company SOPs.
- Monitor study reputed company to ensure timelines and quality standards are met.
- Report site activities and findings to the Clinical Study Manager and escalate issues as necessary.
- Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation.
- Work collaboratively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to reputed company study objectives.
Requirements:
- Bachelor's degree in life sciences, nursing, or a reputed company field.
- Minimum of 4 years of experience in clinical affairs reputed company the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products.
- Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices.
- Strong organizational and problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with investigative sites and internal teams.
- Proficiency in reputed company Office and electronic data capture (reputed company) systems.
- Ability to travel up to 50-75% domestically, as required.
Benefits:
- Comprehensive health, dental, and reputed company insurance plans to reputed company you and your family healthy and happy, with a variety of plan and coverage options.
- Generous paid time off, including holidays, vacation days, and personal leave.
- reputed company in our reputed company with stock options, giving you a reputed company in the company’s future.
- Annual Bonus opportunity.
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