Clinical Research Associate II

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Job description

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

*Summary of the Position:*

We are looking for a Clinical Research Associate II to join our Clinical Operations department. You will be based remotely in the Netherlands.

You will have previous experience in a clinical trials environment or have readily transferable skills and is responsible for conducting site visits independently. You will m onitor the progress of clinical trials with investigators onsite or remotely to ensure clinical trials are conducted, documented and reported in accordance with the protocol, standard operating procedures (SOPs), all applicable regulatory requirements and ICH-GCP.

You will attend study meetings, perform visits (independently), acts as a site manager whilst working closely with Project Management to ensure timely delivery of key study tasks.

*Key Accountabilities:*

* Contribute to site identification and feasibility activities.
* Responsible for all aspects of study site management. (eg. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc.).
* Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File.
* Conduct pre-study visits, site initiation visits, monitoring visits and site closeout visits.
* Assesses IP accountability, dispensation, and compliance at the investigative sites.
* Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.
* Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).
* Facilitates site audits and audit finding resolutions.
* May supervise work of, or mentor, less experienced CRAs.
* Serves as an observational visit leader.

*Minimum Requirements:*

*Essential:*

* Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience
* Experience as Clinical Research Associate; or equivalent relevant experience.
* Good Communication Skills
* Proficiency in written and spoken English, fluent in host country language
* Good knowledge of European clinical research regulations & ICH-GCP

* Desirable:
*

* Advanced degree (Masters, MD, PhD)
* CRA II experience in a CRO or Pharmaceutical setting
* Strong presentation skills
* Ability to establish/maintain good working relationships with colleagues and clients
* Proven ability to gain in-depth protocol knowledge

Job Profile - Clinical Research Associate II.docx

* Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. *