We are looking for home based CRAs/ SR CRAs in Portugal to work in one of our 3 different departments – Clinical Monitoring, Global Functional Resourcing and Real World and Late Phase Research-. Our diversity of projects will allow you to gain experience and be familiar with different therapeutic areas and protocols.
We are hiring experienced CRAs to conduct monitoring visits for assigned protocols and study sites. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
RESPONSIBILITIES
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
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Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
May provide assistance to less experienced clinical staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Good therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Good written and verbal communication skills including good command of English language
Good organizational and problem-solving skills
Effective time management skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor’s degree in a health care or other scientific discipline and 1 or more years of monitoring experience.
Fluent English and Portuguese will be required.
Availability to travel and work permit are mandatory.