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 DUTIESMonitor 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 outManage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completionManage and track the preparation and return of investigational supplies at individual sitesMonitor and document investigational product dispensing, inventory, and reconciliationMonitor and document laboratory sample storage and shipmentMonitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalitiesReview source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issuesReview data queries and listings, and work with study centers to resolve data discrepanciesReview regulatory documentation for accuracy and completeness, and support study centers with regulatory issuesMaintain complete and accurate study files and review files to ensure all appropriate documentation is presentMaintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trialsServe as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issuesOTHER QUALIFICATIONSDetail-orientedExcellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skillsFlexibility with changing prioritiesAbility to efficiently perform and prioritize multiple tasksFamiliarity with the medical and pharmaceutical industries, and related terminology and practicesExtensive knowledge of FDA regulations and their practical implementationAbility to travel, including by air or by car on short noticeComputer proficiency in Microsoft Word, Excel, and PowerPointEDUCATION AND/OR EXPERIENCERN 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 positionPERKS AND BENEFITSCompetitive payCareer growthFull medical, dental, and vision benefit packages401(k) with matchCommuter benefitsLegal benefitsThe 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.
ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
