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 DUTIESMonitoring 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 outManaging and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completionManaging, preparing, sending, tracking, and returning investigational supplies at individual sitesMonitoring and documenting investigational product dispensing, inventory, and reconciliationMonitoring and documenting laboratory sample storage and shipmentMonitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalitiesReviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issuesReviewing data queries and listings, and working with the study centers to resolve data discrepanciesReviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issuesMaintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is presentMaintaining 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 SOPsOTHER 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 medical and pharmaceutical industry, and related terminology and practicesExtensive knowledge of FDA regulations and their practical implementationAbility to travel, including by air or by car on short noticeA valid driver's license with access to a car with up-to-date car insurance Computer proficiency in Microsoft Word, Excel, and PowerPointEDUCATION AND/OR EXPERIENCEBachelor 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 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.
