Clinical Research Associate

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Freelance Clinical Research Associate to join one of our partner companies, a global health care company.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. 

 

Main Job Tasks and Responsibilities:

• On-site interim monitoring visits and study site closure visits according to the monitoring plan.

• Collection of essential documents from the site(s).

• Assure accurate, complete and current source documents are being maintained. Collect study specific data, as needed.

• Ensure the study protocol is being followed and conducted in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and applicable regulatory guidance.

• Meet with the investigator and study site personnel to discuss the study status and compliance issues (if applicable). Motivate/influence them to meet study timelines.

• Ensure electronic Case Report Forms (eCRFs) are a complete and accurate representation of the source documents and assure timely submission of data, and query resolution including appropriate reporting and follow-up for all safety events by site personnel.

• Ensure safety and protection of study subjects.

• Train study site personnel on the protocol and applicable regulatory requirements with pertinent project team members. Retrain as necessary.

• Appropriately elevate serious or outstanding issues to the Company.

• Administration of clinical trial, checking and maintaining study files.

• Assure study product supply, accountability, and storage procedures are acceptable.

• Coordination of Clinical Study Supplies.

• Queries resolution.

 

Education and Experience:

• University Degree in scientific medical or paramedical disciplines.

• Previous proven experience as a CRA, performing on-site monitoring activities.

• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirement.

• Fluent in English

• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)

• Willingness to travel

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

 

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Keywords: Freelance Clinical Research Associate, Freelance CRA, Site Management, Monitor, Monitoring, Training, Travel, Contract Research Organisation, CRO.

 

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