Mindlance
Senior Clinical Research Associate
Mindlance, Parsippany, New Jersey, us, 07054
Job Description:s a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
The Senior Clinical Research Associate (CRA) will act as a liaison between Ferring (the study Sponsor) and the sites/clinics that conduct their assigned clinical studies. Focused primarily on ensuring data quality and regulatory compliance, the CRA will work closely with the Principal Investigator and their staff at their assigned clinical study sites. The Senior CRA will identify and/or resolve data queries and will ensure identification and reporting of safety events and/or device deficiencies. Requiring little supervision, the Senior CRA will review site files and processes to ensure that applicable regulations are being followed. They will actively participate in site identification and qualification activities. Assigned studies tend to be larger, more complex studies used to support device registrations.
Responsibilities include, but are not limited to:Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators)cts as the primary liaison between Ferring and the investigational sitePerform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to planConducts source document verification per planRoutinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and proceduresSite interactions involve prioritization of subject safety including appropriately administered informed consentReview/report AE/SAEs and protocol deviations per industry and standardsMaintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parametersMaintain all project supporting systems, e.g. CTMS, EDC, eTMF, etcProduce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards)Collaborate with the studies cross-functional team members and actively participate in meetingsssist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.Make sure site staff are adequately trained in all project-related requirements and tasksSupport audit activities, as appropriateEnsure site(s) maintains an acceptable inventory of clinical supplies and associated documentationRigorously maintain compliance with the company's business travel and expense policiesEDUCATION AND EXPERIENCE
Bachelor's Degree or higher in a healthcare or science related field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional needGood Clinical Practices (GCP) certification from an accredited program is required2+ years of relevant clinical research experience as a field-based CRA is required; medical device experience is preferredKNOWLEDGE AND SKILLS
Fluent knowledge of spoken and written English language, including medical terminologySuperior written and verbal communication skillsProficiency in presentation preparation and deliveryTechnical savviness with an ability to understand the impact technology has on increasing effectiveness and performancePrevious experience with EDC, CTMS and eTMF systems requiredUnderstanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPbility to work in and promote team cohesiveness in a virtual/remote environmentExhibit flexible organizational change approaches with a growth mindsetDemonstrated ability to prioritize multiple tasks with challenging timelines and resultsbility to master understanding of the disease state and product(s) under investigation
With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
The Senior Clinical Research Associate (CRA) will act as a liaison between Ferring (the study Sponsor) and the sites/clinics that conduct their assigned clinical studies. Focused primarily on ensuring data quality and regulatory compliance, the CRA will work closely with the Principal Investigator and their staff at their assigned clinical study sites. The Senior CRA will identify and/or resolve data queries and will ensure identification and reporting of safety events and/or device deficiencies. Requiring little supervision, the Senior CRA will review site files and processes to ensure that applicable regulations are being followed. They will actively participate in site identification and qualification activities. Assigned studies tend to be larger, more complex studies used to support device registrations.
Responsibilities include, but are not limited to:Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators)cts as the primary liaison between Ferring and the investigational sitePerform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to planConducts source document verification per planRoutinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and proceduresSite interactions involve prioritization of subject safety including appropriately administered informed consentReview/report AE/SAEs and protocol deviations per industry and standardsMaintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parametersMaintain all project supporting systems, e.g. CTMS, EDC, eTMF, etcProduce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards)Collaborate with the studies cross-functional team members and actively participate in meetingsssist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.Make sure site staff are adequately trained in all project-related requirements and tasksSupport audit activities, as appropriateEnsure site(s) maintains an acceptable inventory of clinical supplies and associated documentationRigorously maintain compliance with the company's business travel and expense policiesEDUCATION AND EXPERIENCE
Bachelor's Degree or higher in a healthcare or science related field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional needGood Clinical Practices (GCP) certification from an accredited program is required2+ years of relevant clinical research experience as a field-based CRA is required; medical device experience is preferredKNOWLEDGE AND SKILLS
Fluent knowledge of spoken and written English language, including medical terminologySuperior written and verbal communication skillsProficiency in presentation preparation and deliveryTechnical savviness with an ability to understand the impact technology has on increasing effectiveness and performancePrevious experience with EDC, CTMS and eTMF systems requiredUnderstanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPbility to work in and promote team cohesiveness in a virtual/remote environmentExhibit flexible organizational change approaches with a growth mindsetDemonstrated ability to prioritize multiple tasks with challenging timelines and resultsbility to master understanding of the disease state and product(s) under investigation