Clinical Research Associate

Opis S.r.l.; Perugia; Remoto; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

Join a leading biotech firm as a Clinical Research Associate in a remote role. You'll oversee clinical trials, ensuring compliance with regulations and managing site interactions. With a requirement of a scientific degree and at least 2 years of experience, you will play a pivotal role in our growing company, offering competitive salaries and career development opportunities.

Servizi

Competitive salary

Opportunity for professional development

Competenze

• At least 2 years of experience in managing and conducting clinical trials.
• In-depth knowledge of ICH GCP principles.
• Able to independently monitor clinical trials.

Mansioni

• Coordinate the execution of clinical trials according to protocols and regulations.
• Perform site monitoring visits (selection, initiation, monitoring, and close-out).
• Manage the progress of assigned studies, ensuring compliance with timelines.

Conoscenze

Enthusiastic

Proactive

Organizational skills

Problem-solving skills

Excellent written communication

Excellent verbal communication

Good command of English

Formazione

University degree in a scientific/life science field

Strumenti

Office Suite

Descrizione del lavoro

As a Clinical Research Associate (CRA) you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.

This is a Remote (work from home) position.

Some of what you will do :

• Identify investigator sites and participate in the feasibility process for new studies
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
• Perform visits remotely according to foreseen applicable procedures and timeframes
• Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
• Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan / projections and motivate Investigators to achieve the targets
• Check the correct submission and completion of informed consent forms
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
• Verify that serious adverse events have been reported using a SAE form, according to OPIS and / or Sponsor procedures
• Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
• 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

Requirements :

• Enthusiastic, knowledgeable and proactive
• University degree in a scientific / life science field
• At least 2 years of experience in managing and conducting clinical trials
• In depth knowledge of ICH GCP principles
• Able to carry out independently all the activities related to the monitoring of clinical trials
• Good knowledge of Office Suite (Word, Excel, PowerPoint)
• Organizational and problem-solving skills
• Excellent written and verbal communication skills including good command of English language

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

We offer a competitive salary with other benefits and opportunity to develop your professional career with an expanding and growing company.

Candidate Privacy Policy

J-18808-Ljbffr