Clinical Trial Assistant

Career opportunity at Igenomix: Clinical Trial Assistant

Exciting opportunity within Igenomix - Pioneers in advanced reproductive genetic testing.

At IGENOMIX we provide advanced services in reproductive genetics. Our broad experience and qualifications make us the global leader in this field. The constant efforts we make in R&D, enable us to create and develop specific tools to support professionals in the reproductive medicine area.

Igenomix is part of Vitrolife Group, Vitrolife is an international medical device and genetic services Group. Vitrolife develops, produces and markets products for reproductive health together with services that provide personalised genetic information to improve clinical practices in infertility, women’s health and rare diseases. Headquartered in Gothenburg, Sweden, the Group currently employs approximately 1,200 people worldwide. Its products, services and solutions are available in more than 110 markets through a network of subsidiaries and distributors. The Group has wide-ranging experience in the fertility field with an advanced research capacity. The Vitrolife share is listed on NASDAQ Stockholm.

We are offering one outstanding opportunity to join our R&D Department as a Clinical Trial Assistant, based in Paterna (Valencia), Spain.

What are you accountable for achieving?
- Obtain and manage the required authorizations from the regulatory authorities. Regulatory start up and management activities.
- Ensure the accuracy and quality standards of the different clinical studies and project documents.
- Provide support managing clinical, regulatory and study-related documents (e.g. informed consent, study protocols, reports, SOPs, etc).
- Provide ongoing administrative support to other members of the clinical study team, supporting other clinical colleagues in tracking study progress.
- Document management, tracking, electronic filing and review.
- Public clinical trials websites registration
- Study Data Base debugging and accuracy
- Participate in investigators meeting
- Contracts management and payments with the participant centers.
- To act as link with researchers and other study personnel.
- General communications to researchers, sites and internal team members via electronic mail or courier or telephone.
- Follow-up reports with regulatory authorities.
- Ensure GCP-ICH, essential documents and regulatory compliance.
- SOPs writing and implementation.
- Perform other administrative duties as assigned by the clinical studies manager, medical director and/or R&D director.

What will you need as a successful applicant?
- Life Science Bachelor’s degree (Biology, Pharmacy, Veterinary, etc).
- Clinical Trials Assistant Master's degree or equivalent (Regulatory Affairs certificate, Clinical Trials Monitoring, etc).
- +2 years of previous demonstrated experience in the field as CTA and/or similar positions (start-up specialist, regulatory ).
- Advanced English level (B2 or higher).
- A thorough knowledge of ICH-GCP and an awareness of local and international regulatory authorities regulations.
- Dynamic, organized, results-oriented, good team player.

Desirable requirements:

- National and international regulatory knowledge (AEMPS, EMA, FDA, etc).
- Previous experience in Gynaecology and Reproductive Medicine.
- Study documents writing and review (Protocols, Consent Forms, SOPs, etc)
- Other languages knowledge.

We offer an attractive compensation package at a very dynamic and innovative company; as well as a unique career opportunity with potential for growth within our organization.