Join our team as a Clinical Research Associate and be a part of groundbreaking research that has the potential to improve and save lives. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Job Title: Clinical Research Associate
Position Overview: As a Clinical Research Associate, you will play a crucial role in the planning, implementation, and monitoring of clinical trials. Your main responsibility will be to ensure that all aspects of the trial are conducted in accordance with ethical, scientific, and regulatory standards. You will work closely with a team of researchers, medical professionals, and study coordinators to ensure the successful completion of the trial.
Key Responsibilities:
- Develop and maintain strong relationships with study sites, investigators, and study coordinators to ensure effective communication and collaboration throughout the trial process.
- Conduct pre-study site visits to assess the readiness of study sites, including reviewing protocols, procedures, and study materials.
- Monitor and track study progress and data collection, ensuring that all data is accurate, complete, and entered in a timely manner.
- Perform on-site visits to study sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
- Identify and resolve any issues or discrepancies that may arise during the course of the trial.
- Conduct training sessions for study site personnel on study protocols, procedures, and data collection methods.
- Review and verify study data, ensuring that it meets quality standards and is consistent with study protocols.
- Prepare and maintain study-related documents, including informed consent forms, study logs, and regulatory submissions.
- Collaborate with the study team to develop and implement strategies for recruitment and retention of study participants.
- Participate in study meetings and provide regular updates on study progress and any issues that may arise.
- Ensure compliance with all applicable regulations and guidelines, including FDA regulations, ICH guidelines, and institutional policies.
Qualifications:
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 2-3 years of experience as a Clinical Research Associate or in a similar role.
- Strong knowledge of GCP guidelines and FDA regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Detail-oriented with strong organizational and time-management skills.
- Ability to travel to study sites as needed.
- Proficient in Microsoft Office and data management software.
- Experience with clinical trial management systems (CTMS) is a plus.
- Certification from the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) is preferred.
Apply now and make a difference in the field of clinical research!.