Clinical Research Associate
- Employer
- ICON Strategic Solutions
- Location
- Italy
- Salary
- Competitive
- Start date
- 11 Aug 2022
- Closing date
- 31 Aug 2022
View more
- Discipline
- Clinical Research, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Responsibilities
The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams. Principal Responsibilities:
- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
- Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits, Interim Monitoring Visits,Close Out visits as assigned.
- Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
- Monitor site compliance with study protocol and GCP.
- Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
- Perform drug accountability and ensure adequate drug supply.
- Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
- Assist study team as necessary in resolving lab queries and other issues.
- Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
- Ensure adequacy of clinical supplies to the site.
- Collect and review site essential documents and ensure site regulatory files are complete and accurate.
- Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
- Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
- Track, report, and follow all action items to resolution.
- Maintain CTMS in a timely fashion, utilizing available reports and study tools.
- Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.
- Assist data management as required.
- Provide co-monitoring support as requested or as necessary to develop additional skills
Qualifications
You are:Dedicated, collaborative and inspire others.Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- BA/BS, or equivalent, or a minimum of 1/2 years of other relevant experience and training. Prior monitoring experience is required.
- Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred.
- Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems.
- Requires effective organizational and time management skills.
- Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail.
- Strong communication and interpersonal skills.
- Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals.
- Flexibility towards work assignments, learning, and travel.
- Responsive and proactive, a team player.
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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