Job Description:
• Conduct site monitoring visits (initiation, routine, and close-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 progress 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 achieve study objectives.
Requirements:
• Bachelor's degree in life sciences, nursing, or a related field.
• Minimum of 4 years of experience in clinical affairs within 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 Microsoft Office and electronic data capture (EDC) systems.
• Ability to travel up to 50-75% domestically, as required.
Benefits:
• Comprehensive health, dental, and vision insurance plans to keep 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.
• Share in our success with stock options, giving you a stake in the company’s future.
• Annual Bonus opportunity.