Clinical Research Associate - Freelance

TFS HealthScience•Amsterdam, OH

11d•Hybrid

About The Position

As part of our CDS Internal Medicine and Neuroscience team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Clinical Research Associate is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.

Requirements

Bachelor’s Degree, preferably in life science or nursing; or equivalent
Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
Able to work in a fast-paced environment with changing priorities.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.

Nice To Haves

Experience with cardiovascular studies with Medical Devices is a big plus.

Responsibilities

Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
Verify proper management and accountability of Investigational Product.
Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
Update CTMS and all other required by projects systems with accurate site level information