Clinical Research Associate, All Levels

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

📋 Description

• Conduct site management and monitoring activities, which include site qualification, initiation, interim monitoring, and close-out visits.

• Engage in clinical trials from their development and planning stages through to study closure.

• Ensure that the assigned clinical trial sites adhere to study protocols, relevant regulations, ICH/GCP guidelines, and company or sponsor SOPs.

• Examine source documentation and clinical data for accuracy, completeness, and consistency.

• Oversee participant safety, informed consent procedures, investigational product accountability, and compliance with the protocol.

• Identify, document, escalate, and assist in resolving issues, including protocol deviations and data queries.

• Maintain key performance metrics in line with company standards, project requirements, and timelines.

• Prepare monitoring reports and necessary study documentation accurately and promptly.

• Collaborate with Clinical Team Leads, Project Managers, sponsors, investigators, site personnel, and cross-functional teams.

• Establish and nurture relationships with clinical research sites and study stakeholders.

• Complete administrative tasks, including expense and time reporting.

• Offer mentoring, guidance, and subject matter expertise to less experienced team members as appropriate.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A degree in life sciences, nursing, pharmacy, or a related field; equivalent education and clinical research experience may be acceptable.

• Prior experience in clinical research, clinical operations, healthcare, or a related field is preferred; experience requirements may vary based on level.

• Candidates with CRA experience should have prior independent monitoring experience and the ability to conduct relevant site visit types.

• Familiarity with Good Clinical Practice (GCP), clinical trial regulations, and research ethics is essential.

• A good understanding of medical terminology, human physiology, and clinical trial processes is required.

• Strong written, verbal, and presentation skills are necessary.

• Proficiency in information technology and clinical trial systems is a must.

• Excellent customer service, communication, and relationship-building skills are expected.

• Flexibility, adaptability, and a keen attention to detail are important.

• Ability to work effectively both in a team environment and independently as needed.

• Strong organizational and time management skills, with the ability to prioritize tasks and meet project timelines.

• Willingness to travel nationally and internationally as required.

• Ideally located on the West Coast or within reasonable access to West Coast clinical trial sites.

🏝️ Benefits

• 99% employer-paid health insurance.

• 100% employer-paid dental and vision insurance.

• 100% employer-paid short-term and long-term disability.

• Life insurance policy.

• 401(k) retirement plan with a 3% employer contribution.

• Flexible and hybrid work options.

• Unlimited PTO for salaried employees.

• 12 corporate holidays.

• Employee Assistance Program (EAP).

• Wellness program.

• Learning & Development stipend that increases with tenure.

• Charitable Match Program.

• Catered lunches on Wednesdays (in-office).