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Clinical Research Associate (Remote)

ClinChoice Inc
Roseland, NJ
  • Posted: over a month ago
  • Full-Time
Job Description
 

Responsibilities:

  • Clinical Research Associate (CRA) supports Clinical Trials Leader in coordinating all protocol specific activities to ensure successful completion.
  • Monitoring all aspects of the clinical trial and participating in all types of site visits ensuring adherence to applicable regulations, investigator integrity and compliance with all study procedures.
  • Performing management of study activities to ensure integrity of clinical data, in adherence to all applicable SOPs and all regulatory requirements.
  • Data handling, reporting, tracking and administrative tasks.
  • Taking an active role in the project team by providing feedback and suggestions for successful completion of the project. Manage and submit regulatory documents, train on master protocols, answer questions of team.
  • Creating and writing trial protocols and presenting these to the clinical trial team.
  • Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
  • Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
  • Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing inventory, and reconciliation.
  • Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
  • Conducting regular site visits, coordinating project meetings, and writing visit reports.
  • Implementing action plans for sites not meeting expectations.
  • Liaising with regulatory authorities.
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Other tasks and responsibilities as needed.

 

Qualifications:

  • Minimum Bachelor’s degree in biological science or a related field.
  • A minimum of 2 years of experience as a clinical research associate or other relevant role.
  • Practical knowledge of FDA and ICH regulations relevant to clinical research.
  • Strong excellent communication skills.
  • Proficient with Microsoft Office Word, Excel, and PowerPoint and other R&D software applications


ClinChoice is an Equal Opportunity Employer / Committed to Diversity

ClinChoice Inc

Address

Roseland, NJ
07068 USA

Industry

Healthcare

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