Clinical Research Associate

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

📋 Description

• Manage the operational elements of clinical trials at investigational sites to guarantee data integrity, compliance with regulations, and adherence to GCP guidelines.

• Assess the resource needs for clinical trials regarding site qualification, initiation, monitoring, and site support.

• Simultaneously collaborate with multiple trial sites and studies across different indications.

• Create and uphold monitoring plans for assigned clinical trials.

• Communicate with clinic and hospital investigators and staff throughout the study process.

• Supervise the setup of trial sites and ensure that they have the necessary trial materials.

• Oversee the activation processes of the sites.

• Develop and track metrics for monitoring and site performance; analyze causes and mitigate study risks.

• Review data to identify any issues or inconsistencies in collection or monitoring.

• Monitor patient enrollment and propose solutions to enhance appropriate enrollment.

• Assist in the processing of data queries, deviations, adverse events, and related items.

• Write reports for monitoring visits.

• Plan and execute activities for trial site close-out.

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

• Coordinate activities related to data management.

• Draft protocols and informed consent documents for management review.

• Conduct literature reviews for new study indications.

• Aid in the development of CRFs and organization of investigator meetings.

• Prepare study status data tables and slide presentations for upper management review.

• Establish and maintain study site investigator binders from initiation to completion.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in Clinical Research, Life Sciences, or a related field.

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

• Prior experience in study supervision is a must.

• Certification as a CRA, such as CCRA, CCRP, or another CRA certification is strongly preferred.

• Passing a 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 essential.

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

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

• Excellent verbal and written communication skills are vital.

• Ability to work independently and collaboratively in a fast-paced environment is essential.

• Capability to manage travel and multiple site relationships simultaneously is required.

• Working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, relevant regulations/standards, and internal organizational policies and SOPs is beneficial.

• Must demonstrate punctuality in starting job responsibilities, maintain a consistent presence throughout the entire shift, and attend scheduled meetings and appointments.

• Flexibility to work outside of normal business hours on weekdays or weekends with reasonable prior notice is necessary.

• Ability to manage travel and multiple site relationships simultaneously is essential.

🏝️ Benefits

• Flexibility to work outside of standard business hours during weekdays or weekends with reasonable advance notice to support business and operational needs as required.