Clinical Research Associate

We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.

What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.

We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.

SUMMARY

The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.

ESSENTIAL DUTIES

• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
• Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
• Monitoring and documenting investigational product dispensing, inventory, and reconciliation
• Monitoring and documenting laboratory sample storage and shipment
• Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
• Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
• Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
• Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
• Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
• Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

OTHER QUALIFICATIONS

• Detail oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to efficiently perform and prioritize multiple tasks
• Familiarity with medical and pharmaceutical industry, and related terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Ability to travel, including by air or by car on short notice
• A valid driver's license with access to a car with up-to-date car insurance
• Computer proficiency in Microsoft Word, Excel, and PowerPoint

EDUCATION AND/OR EXPERIENCE

• Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
• 2 years of prior experience as a Clinical Research Associate preferred

PERKS AND BENEFITS

• Competitive pay
• Career growth
• Full medical, dental, and vision benefit packages
• 401(k) with match
• Commuter benefits
• Legal benefits
• The best coworkers, if we do say so ourselves