Sorry, this job is no longer available.

(Loading More Opportunities)

Inhouse CRA

Title: Clinical Research Associate: In-House
Location: Bethlehem, Pa
Schedule: First Shift
Type: Permanent with benefits
Start date: Immediate

The Clinical Research Associate (CRA) is responsible for assisting with the execution of clinical studies. Responsibilities include coordinating, monitoring, and oversight of clinical studies to ensure compliance with the protocol and SOPs, ICH GCP, and all applicable regulatory standards. This position is onsite in Bethlehem, PA.

Responsibilities:

  • Develop clinical documents such as study protocols, data collection forms, informed consent forms, monitoring plans, clinical study reports, and any other study related documents.
  • Conduct pre-study, initiation, interim, and close-out site visits and complete trip reports and follow-up letters in a timely manner.
  • Identification of qualified clinical investigators.
  • Design and provide training to investigators and coordinators during initiation visits.
  • Monitor clinical studies to ensure compliance with the protocol, ICH-GCP guidelines, and all applicable regulations.
  • Management of clinical sites to include site selection, budget negotiation, study start-up, review and approval of regulatory documents, recruitment and enrollment, and maintenance of study documents through the course of the study.
  • Review clinical data for completeness and accuracy.
  • Database creation (excel), database entry, and limited analysis of clinical data for analytical and clinical studies.
  • Oversight of CROs, study vendors, and laboratory vendors for adherence to deliverables, budget, and timelines.
  • Set up and maintenance of Trial Master File.
  • Assists with the generation of clinical portions of regulatory submission documents and responses to any inquiries during regulatory authority review.
  • Prepares for and participates in inspections by FDA, Notified Bodies, and other regulatory agencies.
  • Provide information and status updates to the clinical trials manager and core team members.

Requirements:

  • Bachelor of Science level education, preferably in a scientific or medical discipline (due to technical expertise required for the job). Courses in immunology and statistics are plus.
  • Training in Good Clinical Practices, Design Controls, Good Laboratory Practices, EU Harmonized Standards, ICH Guidelines.
  • 2 years + experience in a CTA or CRA role. Previous monitoring experience (in-house or external) is a plus.
  • Knowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics.
  • Knowledge of EU Medical Device and In Vitro Diagnostics Regulations.
  • Outstanding organizational and time-management skills such as prioritizing/organizing to meet deadlines of multiple projects with overlapping deliverables.
  • Ability to effectively communicate orally and in writing at all corporate levels (subordinates, peers, executive management) as well as outside the company.
  • Ability to interact with clinical laboratories on a technical level.
  • Advanced PC Skills (Microsoft Word, Excel, and PowerPoint)
  • Ability to travel up to 40% over the year

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal, and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Company
System One
Posted
10/06/2021
Type
Full time
Location
Bethlehem, PA 18015, US