Direct message the job poster from ProTrials Research, Inc.
Chris Busche, MS
Senior Clinical Recruiter at ProTrials Research
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
Seniority level
Associate
Employment type
Full-time
Job function
Research
Industries
Biotechnology and Pharmaceutical Manufacturing
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