Clinical Research Associate Jobs

Position Title

Clinical Research Associate

Work Hours

8 Hours/day or more as needed

Report to

Director – Project Management

Benefits

None

Job Location

Edison, New Jersey 08817 or Remote or Hybrid

Job Type

Contract (~24 months)

About Us:

·Jupiter Research Services is the fastest-growing, independently owned clinical trials & supply organization, We, are looking for highly qualified, experienced, and passionate professionals, dedicated to providing unparalleled customer service, to help the organization continue to grow the business forward.

Job Responsibilities:

·Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.

·Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

·Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final selection.

·Oversees research technical and/or administrative staff, to include hiring, training, goal-setting, and distribution of workload.

·Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.

·Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.

·Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.

·Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.

·Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.

·Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.

·Performs miscellaneous job-related duties as assigned.

·Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study

Candidate requirements:

·Bachelor's degree (or equivalent) in a Science or a related field strongly preferred

·Preferably in the field of comparator sourcing and/or clinical packaging and labelling

·Familiarity with ERP system such as QuickBooks

·Experience hosting/performing internal and external audits is preferred

Competencies

·Oncology, Ophthalmology and Metabolic Diseases experience

·Minimum 3 years of experience as an independent CRA

At Jupiter Research Services, we offer comprehensive training and development programs to employees to enable them to excel in their roles. We provide our team with a platform in which to continually progress and excel and deliver on our promises to our clients. Our people are results driven, tenacious and customer focused. If you think you have what it takes to be part of a successful team with an exciting future, please apply today!

You can apply to this role with just an email to [email protected] or WhatsApp: +1 848 248 1611