Senior Clinical Research Associate

22 hours ago

Parsippany, United States Mindlance Full time
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 site
  • Perform 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 plan
  • Conducts source document verification per plan
  • Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures
  • Site interactions involve prioritization of subject safety including appropriately administered informed consent
  • Review/report AE/SAEs and protocol deviations per industry and standards
  • Maintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters
  • Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc
  • Produce 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 meetings
  • ssist 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 tasks
  • Support audit activities, as appropriate
  • Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation
  • Rigorously maintain compliance with the company's business travel and expense policies
EDUCATION 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 need
  • Good Clinical Practices (GCP) certification from an accredited program is required
  • 2+ years of relevant clinical research experience as a field-based CRA is required; medical device experience is preferred
KNOWLEDGE AND SKILLS
  • Fluent knowledge of spoken and written English language, including medical terminology
  • Superior written and verbal communication skills
  • Proficiency in presentation preparation and delivery
  • Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance
  • Previous experience with EDC, CTMS and eTMF systems required
  • Understanding 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, HIP
  • bility to work in and promote team cohesiveness in a virtual/remote environment
  • Exhibit flexible organizational change approaches with a growth mindset
  • Demonstrated ability to prioritize multiple tasks with challenging timelines and results
  • bility to master understanding of the disease state and product(s) under investigation

  • Clinical Research Associate, Sponsor Dedicated, IVD

    4 weeks ago

    Parsippany, United States IQVIA Full time

    Position Summary The Clinical Research Associate (CRA) will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: Ensuring studies are conducted and documented in accordance with...

  • Clinical Research Nurse

    2 months ago

    Parsippany, United States SkyElia Full time

    About the job Clinical Research Nurse Nurses with experience in any of the following areas are strongly encouraged to apply: Clinical trial or study, Oncology, or Peer review. Shift(s) available: day shift, night shift, and mid shift Job types available: full time, part time, and per diem Responsibilities: Coordinate and manage patient care in line with...

  • Tax Senior Associate Position

    1 week ago

    Parsippany, New Jersey, United States CohnReznick LLP Full time

    CohnReznick LLP is a Professional Services and Business Advisory firm seeking a Tax Senior Associate to join our Commercial Tax Services team in Parsippany, NJ. This hybrid position offers the flexibility to work both remotely and in the office.Job Description:We are looking for an individual with experience in financial statement preparation, specifically...

  • Clinical Research Associate

    4 weeks ago

    Parsippany, United States IQVIA Full time

    Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Clinical Research Analyst

    2 weeks ago

    Parsippany, New Jersey, United States IQVIA Full time

    About the JobIQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence. We are committed to improving patient outcomes and population health worldwide.This role will involve working with clients to investigate trends and data characteristics, developing programming documentation, and presenting results to...

  • Tax Senior Associate

    4 weeks ago

    Parsippany, New Jersey, United States CohnReznick LLP Full time

    About CohnReznick LLPCohnReznick is a leading professional services firm that provides comprehensive tax, audit, and advisory services to clients across various industries.Role OverviewWe are currently seeking an experienced Tax Senior Associate to join our Commercial Tax Services team in Parsippany, NJ. This role will involve working with a dynamic team to...

  • Research Nursing Manager

    3 weeks ago

    Parsippany, New Jersey, United States SkyElia Full time

    About UsSkyElia is a forward-thinking healthcare organization that strives to deliver exceptional patient care and advance the field of clinical research. Our team of dedicated professionals works tirelessly to improve patient outcomes, and we are seeking an experienced Clinical Research Nurse to join our ranks.Job SummaryThe Clinical Research Nurse will be...

  • Senior Associate Employment Law

    6 days ago

    Parsippany, New Jersey, United States Kaufman Borgeest & Ryan LLP Full time

    NJ Comprehensive Total Rewards Package includes comprehensive health and well-being benefits, personal and professional development opportunities, career growth prospects, and a collegial and supportive culture. As a member of our Employment Litigation team, you will work collaboratively with senior litigators to develop litigation strategies, draft legal...

  • Respiratory Research Director

    6 days ago

    Parsippany, New Jersey, United States Lifelancer Full time

    We're looking for a highly experienced Respiratory Research Director to join our team at Lifelancer in West Chester, PA office or Parsippany, NJ office. As a key contributor to our clinical leadership, you will be responsible for securing the required human resources to implement the Clinical Development plan and ensuring clinical trials comply with clinical...

  • Senior Commercial Litigation Attorney

    1 month ago

    Parsippany, New Jersey, United States The Rockridge Group Full time

    Role OverviewWe are seeking an experienced Commercial Litigation Associate Attorney to become an integral part of our team, working closely with clients, partners, and other attorneys to provide counsel, draft legal documents, and contribute to the successful execution of client transactions.About The RoleThe ideal candidate will have a Juris Doctor (JD)...

  • Litigation Associate

    3 months ago

    Parsippany, United States The Rockridge Group Full time

    We represent s a boutique law firm dedicated to providing exceptional legal services and client service. The Outside General Counsel Solution™ is designed to provide affordable, high-quality legal services by providing a virtual law department to early stage and mid-market companies that do not have their own inhouse legal team. With a commitment to...

  • Litigation Associate

    2 months ago

    Parsippany, United States The Rockridge Group Full time

    We represent s a boutique law firm dedicated to providing exceptional legal services and client service. The Outside General Counsel Solution is designed to provide affordable, high-quality legal services by providing a virtual law department to early stage and mid-market companies that do not have their own inhouse legal team. With a commitment to...

  • Clinical Contracts Manager

    3 months ago

    Parsippany, United States Net2Source Inc. Full time

    Job Description:Title: Mgr, Clinical Contracts & Finance - III* Location: Parsippany NJ/Foster City, CA/ Santa MonicaDuration: 12+ Months (Extendable)Pay Range:$70 - $80 per hour on W2.Description: This is an onsite position 3 days a week. Candidate can be based in either FC or NJ or Santa Monica locations 12 months Client is currently seeking an industry...

  • Associate Director, Medical Economics Research

    4 weeks ago

    Parsippany, NJ, United States Pacira BioSciences, Inc. Full time

    About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions...

  • Tax Senior Manager Role

    3 weeks ago

    Parsippany, New Jersey, United States CohnReznick LLP Full time

    As a Tax Senior Manager, you will be responsible for providing property tax compliance and consulting services to our clients. This role requires a minimum of 7+ years of experience in tax, with a focus on property tax compliance and consulting.About CohnReznick LLPCohnReznick LLP is one of the nation's top Professional Services and Business Advisory firms....

  • Senior Lawyer

    3 weeks ago

    Parsippany, New Jersey, United States The Rockridge Group Full time

    About The Rockridge GroupWe are a boutique law firm dedicated to delivering exceptional legal services and fostering a culture of excellence. Our Outside General Counsel Solution provides affordable, high-quality legal services to early stage and mid-market companies without in-house legal teams.With a commitment to excellence and attention to detail, we...

  • Global Contracts and Vendor Management Expert

    1 month ago

    Parsippany, New Jersey, United States Net2Source Inc. Full time

    Senior Sourcing Manager Clinical Trials Job OverviewNet2Source Inc. is seeking a highly skilled and experienced Senior Sourcing Manager Clinical Trials to join our team. This role offers the opportunity to work with a leading provider of outsourced clinical trial management services and contribute to the delivery of high-quality results in a fast-paced and...

  • Senior Oracle DBA in NJ

    2 weeks ago

    Parsippany, New Jersey, United States Saxon Global Full time

    Job Title: Senior Oracle DBA in NJAre you an experienced Oracle DBA looking for a new challenge? We are seeking a highly skilled and motivated individual to join our team as a Senior Oracle DBA in NJ. In this role, you will be responsible for building services and coming up with appropriate database solutions to business problems. You will also be...

  • Senior Foreclosure Associate

    1 week ago

    Parsippany, New Jersey, United States Fein, Kahn, Such, & Shepard, PC Full time

    Job OverviewWe are a mid-size general practice law firm with offices in Parsippany, New Jersey; Rochester, New York and Allentown, Pennsylvania.We have relocated our Parsippany office to The Arbors complex, a newly renovated 5-building campus spread over 60 acres and including 3 on-site full-service cafeterias, two high-tech conference centers, a 1.5-mile...

  • Associate Counsel

    1 month ago

    Parsippany, New Jersey, United States The Rockridge Group Full time

    We are seeking a highly skilled Commercial Litigation Associate Attorney to join our team at The Rockridge Group, a boutique law firm dedicated to delivering exceptional legal services.Job DetailsEstimated Salary: $190,000 - $240,000 per year.Job SummaryThis role involves managing a diverse caseload of commercial litigation matters from inception to...