Clinical Research Associate - I

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA)
  3. United States
Somerville, New Jersey
Posting date: 04 Apr 2019
CR.MJ.22550_1554374391

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical Research Associate I position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its New Jersey-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

Job Responsibilities:

  • Ensuring that all work-related activities, and decisions embody the Johnson & Johnson Credo Values.
  • Verifying the safety and well-being of study subjects are maintained for assigned study sites.
  • Supporting the operational execution of clinical trials and ensure collection of high quality, substantiated data.
  • Executing clinical trial activities following established standard operating procedures, good clinical practices, and regulatory requirements.
  • Being accountable for study site performance and providing high quality data according to overall project timeline.
  • Assisting Clinical Operations staff and study site staff to quickly and effectively resolve issues; Responding to problems and assists in implementing corrective and preventive actions, if required.
  • Verifying Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
  • Supporting patient recruitment and retention activities.
  • Performing site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
  • Assisting with internal communication of important clinical data and events.
  • Supporting organization of Investigator and other study training meetings, if required.
  • Functioning as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
  • Understanding business value of clinical projects and balances overall business objectives and functional needs.
  • Supporting the implementation of new clinical systems/processes.
  • Interfacing and collaborating with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
  • Knowing, understanding, incorporating, and complying with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

Skills and Requirements:

  • A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
  • At least 5 years of relevant experience; Previous clinical research experience required.
  • Previous medical device monitoring or equivalent experience required.
  • Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
  • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
  • A Clinical/medical background is highly desirable.
  • Ability to travel up to 80% of time.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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