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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 Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%.
ESSENTIAL DUTIES
Monitor 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
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
Manage and track the preparation and return of investigational supplies at individual sites
Monitor and document investigational product dispensing, inventory, and reconciliation
Monitor and document laboratory sample storage and shipment
Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
Review data queries and listings, and work with study centers to resolve data discrepancies
Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues
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 the medical and pharmaceutical industries, 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
Computer proficiency in Microsoft Word, Excel, and PowerPoint
EDUCATION AND/OR EXPERIENCE
RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
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