SMA I

Pharmaceutical Research Associates, Inc; Logroño; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a Clinical Trial Assistant / Site Management Associate (CTA/SMA) to support Clinical Research Associates (CRAs) in managing investigational sites. The role involves ensuring protocol compliance, performing remote monitoring, and assisting with study documentation. Ideal candidates will have a background in Life Sciences or nursing, along with clinical research experience. The company offers competitive benefits and values diversity and inclusion in the workplace.

Servicios

Health Insurance

Annual Leave

Retirement Planning

Employee Assistance Programme

Life Assurance

Flexible Benefits

Formación

• 2-3 years of clinical research experience required.
• Strong knowledge of ICH guidelines and GCP.

Responsabilidades

• Provide support to CRAs for managing investigational sites.
• Perform remote site management and monitoring activities.
• Assist with site quality management activities.

Conocimientos

Clinical Research

Project Management

Communication

Educación

BA / BS in Life Sciences

RN

Herramientas

EDC

IVRS

CTMS

Microsoft Office

Descripción del empleo

As a CTA / SMA you will work closely with the Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator / site communications and clinical monitoring tracking at a site, regional and global level. In addition, the SMA will liaise with the study team to ensure study information is properly communicated to the site and CRAs. Performs remote site management and monitoring activities on assigned project(s) in accordance with FDA / EMA and / or local regulations and guidelines, ICH GCPs. Reviews study data from various sources remotely. Contacts study sites to collect study documentation, resolves issues and requests outstanding information.

Responsibilities

What you will be doing :

• Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance
• Remotely reviews EDC
• Remotely reviews drug accountability log (when possible)
• Ensures study systems are updated per agreed study conventions (e.g. CTMS)
• Assist local SSU specialist with contracts negotiations and RGL’s site documentation
• Perform QC of the eTMF (country / site level) for a certain study
• Assist investigational sites with study start-up activities to ensure study specific supplies are received
• Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.) as needed
• Contact clinical sites for specific requests between visits, including enrollment updates, challenges with recruitment, supplies, missing TMF documentation, data entry timelines, data query follow-up, and follow-up on action items from previous site visits
• Track patient enrollment and assist with recruitment efforts by maintaining regular site contact
• Assist CRAs with preparation and follow-up for all types of site visits (communicating data entry, queries, tracking reports IRT / DM / Imaging / eCOA / Labs, TMF support and maintenance, site performance, point of escalation, etc.)
• Serve as primary CRA back-up for the site
• May assist with tracking project specific training for site personnel
• Conduct Pre-Study visits and / or Close-out Visits as needed; Independently co-monitor on assigned studies as needed
• Assist with site quality management activities, including site audits and site inspections
• Assist the CRA with Action Item and Protocol Deviation review and follow-up
• Maintain FAQ list for assigned studies, as needed
• Document site and sponsor contact and study interactions in a timely and professional manner
• Assist with resolution of investigational site data queries, especially during interim activities and DB Lock
• May provide study-specific direction, training, and mentoring to the monitoring team members

Qualifications

You are :

• Position requires BA / BS preferably in the Life Sciences, or RN
• Minimum of 2-3 years of clinical research experience as Sponsor CTS / CTA or Site Coordinator
• Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
• Strong knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems
• Proficient in the use of Microsoft Office
• Ability to work highly independently across multiple studies, projects and sites
• Ability to work effectively in a team / matrix environment
• Ability to understand technical, scientific and medical information
• Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Works with a high quality and compliance mindset

What ICON can offer you : Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits focused on well-being and work-life balance opportunities for you and your family. Examples of our benefits include :

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, offering 24-hour access to a global network of over 80,000 independent specialised professionals
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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