Sma I

buscojobs España; Zaragoza; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in clinical research is seeking a CTA/SMA to support Clinical Research Associates. This role involves remote site management, ensuring compliance with regulations, and assisting with various clinical monitoring tasks. The ideal candidate will have a background in Life Sciences and experience in clinical research. The company offers a diverse culture, health insurance, retirement planning options, and flexible benefits.

Servicios

Health insurance options

Retirement planning options

Flexible benefits

Formación

• 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator.
• Knowledge of ICH guidelines, GCP, and local regulations.

Responsabilidades

• Provide support to CRAs for managing investigational sites.
• Remotely review EDC and drug accountability logs.
• Assist with site quality management activities, including audits.

Conocimientos

Communication

Problem Solving

Planning

Organization

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 site, regional, and global levels. You will liaise with the study team to ensure proper communication of study information to sites and CRAs. Your responsibilities include remote site management and monitoring activities in accordance with FDA/EMA, local regulations, guidelines, and ICH GCPs. You will review study data remotely, contact study sites to collect documentation, resolve issues, and request outstanding information.

Responsibilities

1. Provide support to CRAs for managing investigational sites and ensuring protocol and regulatory compliance.
2. Remotely review EDC and drug accountability logs.
3. Ensure study systems are updated per study conventions (e.g., CTMS).
4. Assist local SSU specialists with contract negotiations and site documentation.
5. Perform QC of the eTMF at country/site level.
6. Assist with study start-up activities and ensure receipt of study supplies.
7. Help develop training materials and content as needed.
8. Contact sites for specific requests, including enrollment updates, recruitment challenges, supplies, TMF documentation, data entry, and follow-up actions.
9. Track patient enrollment and support recruitment efforts.
10. Assist CRAs with site visit preparations, follow-up, and documentation.
11. Serve as primary CRA backup for sites.
12. May assist with tracking training for site personnel.
13. Conduct pre-study and close-out visits; co-monitor assigned studies.
14. Assist with site quality management activities, including audits and inspections.
15. Support CRA with action item and protocol deviation reviews.
16. Maintain FAQ lists for studies and document interactions professionally.
17. Assist with resolving site data queries, especially during interim activities and DB lock.
18. Provide study-specific training and mentoring to monitoring team members.

Qualifications

1. BA/BS in Life Sciences or RN preferred.
2. 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator.
3. Knowledge of ICH guidelines, GCP, PhRMA, FDA CFR, ethics, HIPAA, and local regulations.
4. Strong understanding of clinical research and drug development concepts.
5. Proficient in EDC, IVRS, CTMS, and Microsoft Office.
6. Ability to work independently across multiple studies and in team environments.
7. Strong planning, organizational, communication, and problem-solving skills.
8. High quality and compliance mindset.

What ICON offers:

We prioritize a diverse culture that rewards performance and nurtures talent. Benefits include:

• Various annual leave entitlements.
• Health insurance options.
• Retirement planning options.
• Global Employee Assistance Programme.
• Life assurance.
• Flexible benefits such as childcare vouchers, gym discounts, travel passes, and health assessments.

ICON is committed to an inclusive environment and equal opportunity employment. We encourage all qualified candidates to apply, regardless of background or disabilities, and will provide accommodations as needed.