Freelance Clinical Research Associate

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

The sponsor-dedicated division of ClinChoice, is searching for a Freelance Clinical Research Associate (CRA). The ideal candidate will have 5 plus years’ experience monitoring clinical trials. Experience monitoring medical device trials relating to cardiovascular indications is required. Work from home and monitor onsite, sites located in Nahariya, Tel Aviv and Jerusalem. Project assignment is approximately 10 months and 0.32 FTE (approximately 9 hours week).

ClinChoice is an international 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 their client counterparts.

Join our team and help us deliver clinical trials that will improve patients’ lives.

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.
• Performs training of site staff in all study procedures to ensure protocol/ICHGCP compliance.
• Conducts and reports periodic monitoring visits onsite and remote, reviews data for accuracy, legibility, completeness, and quality of Case Report Form (CRF) in compliance with the protocol, SOPs, and ICH-GCP requirements to ensure data integrity and subject safety.
• Conducts close out visits.
• Supports investigator site management and communication.
• Supports ongoing Ethics Committee and/or Regulatory Authority communication.
• Adapts and translates Patient Information Leaflets and Informed Consent Forms
• Cooperates with the site staff to ensure proper reporting from the site of the safety issues (adverse events and adverse reactions 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 the study budget after appropriate and documented training.
• May support the submission process in the project (or region)
  
  

Education and Experience:

• You have a University Degree in scientific medical or paramedical discipline.
• 5 years or more CRA experience; performing main monitoring visit types (Site Qualification, Site Initiation, Interim Monitoring + Close Out).
• Medical device monitoring is essential.
• Monitoring cardiology trials is a must.
• Excellent knowledge of clinical trial operations, ICH-GCP 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 acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step. 

If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact [email protected] for more information.

Who will you be working for?

About ClinChoice

ClinChoice is a leading full-service CRO dedicated to offering high-quality one-stop service to pharmaceutical, biotechnology, medical device, and consumer products clients. Some of these services include Clinical Operations, Project Management, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. ClinChoice has established major delivery centers across the US, Canada, China, Europe, India, Japan, and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence across Asia, North America, and Europe.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is 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 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. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Freelance, Freelancer, Contractor, Medical Device, Cardiovascular, Ethics Committee, GCP

#Freelance #Temporary