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SalaryThe 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
- This position's pay range is $115-140k/year.
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
Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.
Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact HR@ProTrials.com.
