SMA I

Pharmaceutical Research Associates, Inc; Madrid; Presencial; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Clinical Trial Associate where you will play a pivotal role in supporting clinical research activities. You will work closely with Clinical Research Associates to ensure compliance and effective communication with study sites. Your responsibilities will include managing study documentation, assisting with site visits, and tracking patient enrollment. This role offers the opportunity to develop your skills in a collaborative environment while contributing to the advancement of medical research. If you are passionate about clinical trials and eager to make a difference, this position is perfect for you.

Servicios

Health Insurance Options

Retirement Savings Plans

Global Employee Assistance Programme

Life Assurance

Flexible Benefits

Formación

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

Responsabilidades

• Support CRAs in managing investigational sites and ensuring compliance.
• Communicate with clinical sites for requests, updates, and documentation.

Conocimientos

Clinical Research Experience

Communication Skills

Problem-Solving Skills

Time Management

Interpersonal Skills

Educación

BA/BS in Life Sciences

RN Qualification

Herramientas

EDC Systems

IVRS

CTMS

Microsoft Office

Descripción del empleo

Overview

As a CTA / SMA, you will work closely with Clinical Research Associates (CRAs) by providing centralized support to regional team members. Your responsibilities include assisting with investigator/site communications, clinical monitoring tracking at various levels, and liaising with the study team to ensure proper communication of study information. You will perform remote site management and monitoring activities in accordance with FDA/EMA, local regulations, guidelines, and ICH GCPs. Additionally, you will review study data remotely, contact study sites for documentation, resolve issues, and follow up on outstanding information.

Responsibilities

What you will be doing:

1. Provide support to CRAs to manage investigational sites and ensure compliance.
2. Review EDC remotely.
3. Review drug accountability logs remotely.
4. Update study systems according to study conventions (e.g., CTMS).
5. Assist with contract negotiations and site documentation.
6. Perform QC of the eTMF at country/site level.
7. Assist with study start-up activities and ensure receipt of study supplies.
8. Develop training content as needed.
9. Communicate with clinical sites for requests, enrollment updates, recruitment challenges, supplies, TMF documentation, data entry timelines, and follow-up actions.
10. Track patient enrollment and support recruitment efforts.
11. Assist CRAs with site visit preparations and follow-ups, including data queries and report tracking.
12. Serve as primary CRA backup.
13. Assist with tracking training for site personnel.
14. Conduct pre-study and close-out visits, and co-monitor studies as needed.
15. Support site quality management activities, including audits and inspections.
16. Assist with review and follow-up of action items and protocol deviations.
17. Maintain FAQ lists for studies.
18. Document interactions with sites and sponsors.
19. Resolve site data queries, especially during interim activities and database lock.
20. Provide training and mentorship to monitoring team members as needed.

Qualifications

You are:

1. Possessing a BA/BS in Life Sciences or RN qualification.
2. Having 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator.
3. Well-versed in ICH guidelines, GCP, PhRMA code, FDA CFR, ethics, HIPAA, and local regulations.
4. Knowledgeable about clinical research concepts and drug development.
5. Proficient in EDC, IVRS, and CTMS systems.
6. Proficient in Microsoft Office.
7. Able to work independently across multiple studies and sites.
8. Effective in team and matrix environments.
9. Capable of understanding technical, scientific, and medical information.
10. Strong in planning, organization, communication, time management, problem-solving, and interpersonal skills.
11. Committed to high quality and compliance standards.

What ICON Can Offer You

Our success depends on our people. We prioritize building a diverse culture that rewards performance and nurtures talent. Benefits include:

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

We are committed to inclusion and providing an accessible environment for all candidates. ICON values diversity and equal opportunity. If you need accommodations during the application process, please let us know. We encourage all qualified applicants to apply, regardless of whether they meet all listed requirements.