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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial monitoringdata entryregulatory submissionsclinical protocol complianceGCPFDA guidelinesICH guidelinesproblem-solving

Soft Skills

organizational skillscommunication skillsinterpersonal skillsrelationship building