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Clinical Research Associate

3 months ago

Newark, United States QPS, LLC Full time
Job DescriptionJob Description

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you

As a Clinical Research Associate (CRA) or Senior CRA with QPS’ Global Project Management Office (cPMO), you’ll be at the heart of our mission to enhance patient health by overseeing clinical studies from inception through completion. Your work will ensure that these studies are conducted in compliance with protocols, standard operating procedures, ICH/GCP/FDA regulations, and other relevant guidelines. You'll be the vital link between clinical investigational sites and our project teams, ensuring smooth operations and robust data quality.

QPS’ Story:

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

If this sounds like your ideal work environment, then we would love to speak with you, so apply today

Please visit our website (www.qps.com) for more information and to see all current openings.

The Job

As a Clinical Research Associate (CRA), you'll be responsible for overseeing and managing clinical trials, ensuring compliance with regulatory requirements, and supporting the integrity of research data; your work will include -

  • Clinical Monitoring: Conduct comprehensive visits (pre-study, initiation, interim, and close-out) including all necessary preparations and follow-ups to ensure smooth and compliant study operations.
  • Site Engagement: Develop and maintain strong relationships with clinical site personnel, addressing any issues and proposing effective solutions.
  • Compliance & Performance: Monitor site performance, ensure adherence to regulations, and provide detailed reports and recommendations for improvement.
  • Regulatory Preparation: Prepare clinical sites for audits by regulatory agencies and assist in data query resolution.
  • Travel & Site Management: Manage approximately 10-12 sites, requiring travel as necessary to oversee study progress and ensure high standards.
  • Patient Recruitment: Focus on meeting enrollment targets and devising innovative strategies to attract participants.
  • Team Collaboration: Engage in weekly sponsor/project management calls and support the Clinical Project Management team with miscellaneous tasks.

Work Location

  • This position is fully remote, with regular/recurring travel to trial sites plus occasional attendance at Investigator Meetings. Midwest-located candidates are preferred. (Please refer to the Telecommuting Policy for complete details on remote work.)

Requirements

  • Deep understanding of the drug development process, including clinical site operations.
  • In-depth understanding of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research.
  • Exceptional communication skills for diverse audiences, including clients/sponsors, cross-functional teams and senior leadership.
  • Able to develop and maintain excellent business relationships, with strong conflict resolution skills; proven skill in holding all parties accountable while maintaining a positive approach.
  • Strong organizational and facilitation skills.
  • Proficiency in Microsoft Office Suite, CTMS and other related systems
  • Ability to manage meetings and relationships in a multicultural environment; demonstrates cross-cultural awareness
  • Capable of maintaining confidentiality and managing conflict effectively.
  • Midwest-located candidates strongly preferred. Most have local access to a large airport (within an hour's drive of your home)

Education & Experience:

  • Bachelor’s degree in clinical or Pharmaceutical Sciences, Nursing, or a related scientific field.
  • At least 10 years of overall clinical research experience, with a minimum of 7 years specifically in CRA roles.
  • Experience in all phases of clinical trials is preferred, from FIH/Phase I through Phase IV studies.
  • Ability to travel (including overnight travel) up to 75%

Why You Should Apply

  • Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
  • Structured Career Ladders that provide excellent growth based on your personal aspirations.
  • Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
  • Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
  • Park-like setting in Newark, Delaware
  • Internal committees designed with the needs and enjoyment of QPS employees in mind.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.