Clinical Research Associate

Location:
**MECHELEN**
**#21121**

Will you be our new ambassador?

**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to join our team.

Let's look together at your first challenge with us

**Clinical Research Associate**

**Scope of work**

**_Key Job Activities:_**
Clinical Study Site Management Tasks:

- Ensures that all work related activities, and decisions embody the Credo Values.
- Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
- Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
- Accountable for study site performance, and providing high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
- Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
- Responsible for supporting patient recruitment and retention activities.
- Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
- Assists with internal communication of important clinical data and events.
- Support organization of Investigator and other study training meetings, if required.
- Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
- Understand business value of clinical projects and balances overall business objectives and functional needs.
- May be involved in other tasks to support Clinical Operations and Operating Company as needed.
- Support the implementation of new clinical systems/processes.
- Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed. **_Administrative Tasks_**
- Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- May be asked to provide additional support to Clinical Operations staff, as needed.

**Profile**:

- A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- At least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant
experience.
- Previous clinical research experience required.
- Previous medical device monitoring or equivalent experience required.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Clinical/medical background - a plus.

**_Knowledge_**
- Requires experience and knowledge working with computer systems
(Microsoft Office - Excel, Word, and Power Point).
- Demonstrated competencies in the following areas are required:

- Leadership
- Written and verbal communications
- Presentation and influencing
- Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).
- Ability to travel up to 80% of time.
- Full driving license.
- Fluent in Dutch and English.

**What can Jefferson Wells do for you?**

As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.