Job Summary
We are looking for a skilled Remote Senior Clinical Research Associate (CRA) to oversee and manage clinical trials from startup to closeout. The ideal candidate will ensure compliance with regulatory requirements and protocol adherence while providing support to site staff and other stakeholders throughout the study process.
Responsibilities
- Manage the overall conduct of clinical trials, ensuring they are executed according to established protocols.
- Perform regular site visits to monitor the progress of studies and verify the integrity of data collected.
- Maintain regulatory compliance and ensure compliance with Good Clinical Practice (GCP) guidelines.
- Collaborate closely with investigators, site staff, and team members to troubleshoot issues and enhance study outcomes.
- Prepare and review study documentation, including protocols, informed consent forms, and reports.
- Assist in training site personnel in study procedures and compliance requirements.
- Participate in the selection, initiation, and monitoring of sites throughout the trial.
Qualifications
- A Bachelor’s degree in Life Sciences or a related field is required; advanced degrees are a plus.
- At least 3 to 5 years of experience in clinical research, particularly in a CRA role.
- Thorough understanding of clinical trial processes, regulatory requirements, and GCP.
- Proven experience with site management and monitoring activities.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently and as part of a collaborative team in a remote setting.
