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, an innovative pharmaceutical company. This will be for 0.6 FTE.

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:

Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
Local EC Submission support for Study included Patient Informed Consent (if applicable).
Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance.
Provide training on CRF/EDC as necessary to site personnel.
Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, eligibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety.
Report Study Progress verbally and in writing to Study Project Leader.
Adapts and translates Patient Information Leaflets and Informed Consent Forms.
Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues.
Escalates any issues to relevant project team members.
May assist in contract negotiation with sites on study budget after appropriate and documented training.

Education and Experience:

University Degree in scientific medical or paramedical discipline.
Prior experience as a CRA and site management.
Extensive experience monitoring studies is required.
Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement.
Fluent in English and local language.
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.

Key words: CRA, Clinical Research Associate, Clinical Research, Clinical Trials, EC submissions, ICH-GCP, Monitoring, Home based, Cardiology, Freelance, Freelancer, Contractor, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-HYBRID #PARTTIME #TEMPORARY

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