Clinical Research Associate

This is a fully remote position, open to applicants in Alabama, +45 more states.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management activities, and close-out visits either on-site or remotely.

• Assess site and site staff performance, providing recommendations and action plans as necessary.

• Communicate and escalate critical issues to the project team promptly.

• Confirm informed consent processes and ensure proper documentation.

• Safeguard subject/patient confidentiality and evaluate risks related to safety and clinical data integrity.

• Review site processes and perform Source Document Reviews.

• Validate clinical data in case report forms and address any queries that arise.

• Utilize hardware and software tools for the review and capture of clinical study data.

• Ensure site compliance with electronic data capture standards.

• Oversee investigational product inventory, including reconciliation, storage, dispensing, and administration as applicable.

• Examine Investigator Site Files and ensure they are reconciled with Trial Master Files.

• Document monitoring activities using the necessary project documentation.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, site status, and ensure action items are resolved.

• Manage site-level activities, communications, deliverables, and timelines effectively.

• Coordinate with study site personnel, ensuring site team training and compliance are met.

• Participate in Investigator Meetings, sponsor meetings, clinical monitoring meetings, and training sessions.

• Aid in audit readiness, preparation, and follow-up actions.

• Provide ongoing site support throughout the study lifecycle from identification to close-out.

• Collaborate with sponsor affiliates, medical science liaisons, and local country staff.

• Train junior staff when requested.

• Identify and report out-of-scope activities.

• Recommend potential sites based on local knowledge of treatment patterns, patient advocacy, and HCP associations.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Strong computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capacity to manage necessary travel of up to 75% on a regular basis.

• Must comply with site requests for medical and other personal information needed for facility access in the US.

• Understanding of local requirements for real-world late-phase study designs.

• Ability to perform chart abstraction activities and gather data effectively.

• Competence to collaborate with Sponsor affiliates, medical science liaisons, and local country staff.

🏝️ Benefits

• Career development and advancement opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Company car or car allowance available.

• Medical, Dental, and Vision health benefits offered.

• Company matching 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on company and individual performance.

• Flexible paid time off (PTO) policy.

• Sick time provided.