[{"additionalPlain":"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.\n \nInformation 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. \n \nProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to 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.\n","additional":"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 is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to 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.
","categories":{"commitment":"Contract","location":"Regional","team":"Clinical Operations","allLocations":["Regional"]},"createdAt":1779225213777,"descriptionPlain":"ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. \n \nOur people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health. \n \nWe are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. \n","description":"ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
\n
ABOUT THE JOB
\n
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ProTrials is seeking a Contract Senior Clinical Research Associate to join our team.
\n
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The Contract Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Contract 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. Contract Sr. CRAs may be required to travel up to 65%.
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Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits\nManage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion\nManage and track the preparation and return of investigational supplies at individual sites\nMonitor and document investigational product dispensing, inventory, and reconciliation\nMonitor and document laboratory sample storage and shipment\nMonitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities\nReview source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues\nReview data queries and listings, and work with study centers to resolve data discrepancies\nReview regulatory documentation for accuracy and completeness, and support study centers with regulatory issues\nMaintain complete and accurate study files and review files to ensure all appropriate documentation is present\nMaintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials\nServe as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues\n\n"},{"text":"HERE IS WHAT YOU BRING TO THE TABLE:","content":"\n\n
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\nDetail-oriented\nExcellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills\nFlexibility with changing priorities\nAbility to efficiently perform and prioritize multiple tasks\nFamiliarity with the medical and pharmaceutical industries, and related terminology and practices\nExtensive knowledge of FDA regulations and their practical implementation\nAbility to travel, including by air or by car on short notice\nProficiency in Microsoft Word, Excel, and PowerPoint\n\n"}],"text":"Contract Senior Clinical Research Associate","country":"US","workplaceType":"remote","opening":"ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
","openingPlain":"ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. \n \nOur people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health. \n \nWe are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. \n","descriptionBody":"\n
ABOUT THE JOB
\n
\n
ProTrials is seeking a Contract Senior Clinical Research Associate to join our team.
\n
\n
The Contract Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Contract 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. Contract Sr. CRAs may be required to travel up to 65%.
\n
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 is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to 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.
","categories":{"commitment":"Full Time","location":"Home-based","team":"Future Jobs At ProTrials","allLocations":["Home-based"]},"createdAt":1751323586872,"descriptionPlain":"Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available. \n \nProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. \n \nOur people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health. \n \nWe are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. \n\n\nABOUT THE JOB\nThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them. \n","description":"Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
ABOUT THE JOB
\nThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.
","id":"f46dbb7d-8f1f-4fec-a8e2-5fd3c93e1500","lists":[{"text":"HERE IS WHAT YOU WILL DO: ","content":"\nProvide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study\nEnsure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements\nDevelop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies\nCreate annotated visit report templates and other documents and strategies related to site management and monitoring\nSupport training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented\nGuide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements\nManage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control\nTrack serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team\nPerform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed\n"},{"text":"HERE IS WHAT YOU BRING TO THE TABLE:","content":"\nRN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training\nPrevious CRA experience preferred\nProven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy\nSolutions-oriented approach to problem solving\nFamiliarity with medical and pharmaceutical industry, and related terminology and practices\nExtensive knowledge of Food and Drug Administration regulations and their practical implementation\nWillingness to travel and perform remote and on-site monitoring, if needed\nProficiency in Microsoft Word, Excel, and PowerPoint\n"},{"text":"HERE IS WHAT WE OFFER: ","content":"\nYour wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.\nWe know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.\nYou invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. \nAt ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.\nWe have the best coworkers, if we do say so ourselves.\n"}],"salaryRange":{"min":135000,"max":159000,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"Our salary ranges are determined by various factors. The actual base compensation for this position may vary depending on experience, market conditions, education/training, skill level, and location.
","salaryDescriptionPlain":"Our salary ranges are determined by various factors. The actual base compensation for this position may vary depending on experience, market conditions, education/training, skill level, and location.\n","text":"Lead Clinical Research Associate - Pipelining for Future Jobs","country":"US","workplaceType":"remote","opening":"Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
","openingPlain":"Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available. \n \nProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. \n \nOur people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health. \n \nWe are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. \n","descriptionBody":"ABOUT THE JOB
\nThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.
","descriptionBodyPlain":"ABOUT THE JOB\nThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them. \n","hostedUrl":"https://jobs.lever.co/protrials/f46dbb7d-8f1f-4fec-a8e2-5fd3c93e1500","applyUrl":"https://jobs.lever.co/protrials/f46dbb7d-8f1f-4fec-a8e2-5fd3c93e1500/apply"}]