Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the operational facets of clinical trials at investigative sites.

• Assess clinical trial staffing needs for site qualification, initiation, monitoring, and support.

• Collaborate with various trial sites and studies across different indications.

• Create and uphold monitoring plans.

• Act as a liaison with clinic and hospital investigators as well as trial personnel.

• Manage the setup of trial sites and ensure the availability of necessary trial materials.

• Oversee the processes involved in site activation.

• Develop and track metrics that evaluate monitor and site performance.

• Analyze data for discrepancies or inconsistencies in collection or monitoring.

• Monitor patient enrollment and suggest strategies to enhance the enrollment of qualified subjects.

• Assist in the management of data queries, deviations, and adverse events.

• Compose monitoring visit reports.

• Formulate and implement site close-out plans and related activities.

• Ensure compliance with ICH-GCP, SOPs, IRB regulations, study protocols, FDA regulations, and ICH guidelines.

• Coordinate activities related to data management.

• Prepare drafts of protocols and informed consents for management evaluation.

• Conduct literature reviews for new study indications.

• Support the development of CRFs and assist in investigator meetings.

• Generate study status data tables and presentation materials for upper management review.

• Create and maintain binders for study site investigators.

• Stay informed about FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, relevant regulations, and organizational policies.

• Begin tasks on time, maintain a consistent presence throughout shifts, and participate in scheduled meetings.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor's degree is required, ideally in Clinical Research, Life Sciences, or a related discipline.

• CRA certification, such as CCRA or CCRP, is highly preferred.

• A minimum of 3 years of pertinent experience in the industry or as a clinic coordinator working with Sponsor companies is required.

• Previous experience in study supervision is essential.

• A favorable background investigation is necessary.

• A valid Class “C” driver’s license is required.

• Comprehensive knowledge of ICH-GCP, FDA regulations, and clinical research methodologies is crucial.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint) is necessary.

• Strong organizational and problem-solving skills, with a keen attention to detail, are required.

• Effective verbal and written communication abilities are essential.

• Ability to work both independently and as part of a team in a fast-paced environment is needed.

• Capability to manage travel and multiple site relationships concurrently is important.

• Willingness to work outside of standard business hours on weekdays or weekends with reasonable notice is necessary.

🏝️ Benefits

• Opportunity for remote work.

• Full-time employment status.

• Role requires up to 50% travel.