As a leading healthcare company, we are committed to improving the lives of patients through innovative and effective treatments. Our team is made up of dedicated professionals who are passionate about making a difference in the lives of others. We offer a dynamic and collaborative work environment, competitive salary, and comprehensive benefits package. If you are a motivated and skilled Clinical Research Associate looking to make a meaningful impact in the field of medical research, we encourage you to apply for this exciting opportunity. We are an equal opportunity employer and value diversity at our company.
Position Title: Clinical Research Associate
Overview: We are seeking a highly skilled and motivated Clinical Research Associate to join our team. As a key member of our clinical research department, you will play a critical role in the development and execution of clinical trials to evaluate the safety and efficacy of our products. The ideal candidate will have a strong background in clinical research, excellent communication and organizational skills, and a passion for advancing medical research.
Key Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials in accordance with company and regulatory guidelines
- Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements
- Develop and maintain relationships with study sites and investigators to ensure timely and accurate completion of study activities
- Review and verify data collected during site visits and ensure data accuracy and integrity
- Identify and resolve any issues that arise during the course of the study, including patient safety concerns and protocol deviations
- Prepare and review study-related documents, including study protocols, informed consent forms, case report forms, and study manuals
- Assist in the development and review of study reports and presentations
- Communicate study progress and any issues to project team members, study sites, and investigators
- Provide training and support to study site personnel on study procedures and protocol requirements
- Coordinate and participate in study meetings, including investigator meetings and site initiation visits
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field
- Minimum of 2-3 years of experience as a Clinical Research Associate in the pharmaceutical, biotechnology, or medical device industry
- Thorough knowledge of GCP guidelines, FDA regulations, and international guidelines for clinical research
- Experience in multiple phases of clinical trials, from start-up to close-out
- Strong organizational, time management, and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Proficient in MS Office and electronic data capture systems
- Willingness to travel up to 50% for site visits and meetings
- Certification as a Clinical Research Associate (CCRA) or equivalent preferred
Our Company: We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.