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Clinical Research Associate II/SCRA

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.  

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.  

We have nourished a true international culture here at Ergomed.  

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.  

Job Description

National Travel Required

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.

Trains investigational site staff as necessary

When applicable, supports preparation of regulatory and / or EC submissions

Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Qualifications

 

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials
  • Full working proficiency in English
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

Additional Information

Why Ergomed  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

  • Training and career development opportunities internally  

  • Strong emphasis on personal and professional growth 

  • Friendly, supportive working environment 

  • Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!  

Quality 

Integrity & Trust  

Drive & Passion  

Agility & Responsiveness  

Belonging 

Collaborative Partnerships  

We look forward to welcoming your application. 

 

Average salary estimate

$60000 / YEARLY (est.)
min
max
$50000K
$70000K

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What You Should Know About Clinical Research Associate II/SCRA, Ergomed

Are you ready to embark on a fulfilling career with Ergomed PLC as a Clinical Research Associate II/SCRA in the beautiful city of Milan, Italy? At Ergomed, we pride ourselves on being a rapidly expanding full-service mid-sized Contract Research Organization (CRO) that specializes in Oncology and Rare Diseases. Since 1997, our company has committed to growth fueled by strategic investments and acquisitions, which means we have both stability and opportunity. As a Clinical Research Associate II/SCRA, you will play a vital role in ensuring that investigational sites are well-prepared and capable of conducting high-quality clinical studies. This includes performing pre-study, initiation, interim, and close-out monitoring visits, both on-site and remotely, as well as training staff and supporting regulatory submissions when necessary. Your extensive experience in phase 2/3 trials will shine as you mentor junior staff and contribute to a culture of excellence. Ergomed champions diversity, equity, and inclusion, creating a workplace where everyone’s voice is heard and valued. With a strong emphasis on work-life balance and employee well-being, Ergomed fosters a dynamic environment where personal and professional growth is prioritized. If you’re looking for a position that not only enhances your career but also allows you to make a significant positive impact on patients’ lives, then joining our team at Ergomed as a Clinical Research Associate II/SCRA is the perfect opportunity for you!

Frequently Asked Questions (FAQs) for Clinical Research Associate II/SCRA Role at Ergomed
What qualifications do I need to apply for the Clinical Research Associate II/SCRA position at Ergomed?

To be considered for the Clinical Research Associate II/SCRA role at Ergomed, candidates should hold a college or university degree in Life Sciences or possess an equivalent combination of education, training, and experience. Additionally, extensive on-site monitoring experience, particularly in phase 2/3 trials, is crucial, as well as proficiency in English and strong communication skills.

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What does a typical day look like for a Clinical Research Associate II/SCRA at Ergomed?

As a Clinical Research Associate II/SCRA at Ergomed, your day typically involves planning and executing monitoring visits, which can occur either on-site or remotely. You will be responsible for ensuring that all facilities and staff are well-equipped to conduct clinical studies. Additionally, mentoring junior team members and collaborating on regulatory submissions are integral parts of your role.

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What kind of training opportunities does Ergomed offer for Clinical Research Associate II/SCRA?

Ergomed is committed to the professional growth of its employees, offering various training and career development opportunities. As a Clinical Research Associate II/SCRA, you will benefit from a structured orientation process, on-the-job training, and access to resources that promote continuous learning and skill enhancement.

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Is travel required for the Clinical Research Associate II/SCRA role at Ergomed?

Yes, the Clinical Research Associate II/SCRA role at Ergomed involves national travel as part of the job responsibilities. You will need to perform monitoring visits at various investigational sites, which may require you to travel regularly depending on the studies being conducted.

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How does Ergomed prioritize work-life balance for Clinical Research Associate II/SCRAs?

At Ergomed, work-life balance is a core value. The company actively promotes a healthy work environment through flexible working arrangements and encourages employees to maintain their mental health and well-being. This supportive approach nurtures job satisfaction and ensures high-quality client service.

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What is the company culture like at Ergomed for Clinical Research Associate II/SCRAs?

Ergomed embraces a diverse and inclusive company culture, fostering an environment where different perspectives are valued. As a Clinical Research Associate II/SCRA, you will experience a friendly, collaborative atmosphere that emphasizes teamwork and mutual respect, enhancing your ability to succeed in your role.

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What opportunities for career progression exist for Clinical Research Associate II/SCRAs at Ergomed?

Ergomed places a strong emphasis on personal and professional growth, providing career progression opportunities for Clinical Research Associate II/SCRAs. Through mentorship, training, and continuous performance evaluations, employees are encouraged to pursue advancement within the company based on their interests and skill sets.

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Common Interview Questions for Clinical Research Associate II/SCRA
Can you describe your experience with phase 2/3 trials relevant to the Clinical Research Associate II/SCRA position?

In your response, highlight specific projects you've worked on, detailing your role in the study design, monitoring, and outcomes. Focus on challenges you overcame and any metrics that demonstrate your effectiveness in managing clinical trials.

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How do you ensure effective communication with investigational site staff?

Discuss strategies you employ to foster open dialogue, such as regular check-ins, providing clear instructions, and being responsive to their needs. Emphasize your ability to build rapport with diverse teams to ensure smooth operations.

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What do you do if you identify compliance issues during a monitoring visit?

Describe your process for addressing compliance issues, such as documenting findings, discussing them with site staff, and developing corrective action plans. Share an example of a past experience where you effectively resolved a compliance issue.

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How do you prioritize your tasks when managing multiple studies at once?

Explain your approach to task prioritization, including tools or methods you use to manage deadlines, monitor progress, and communicate with stakeholders. Illustrate this with an example of how you successfully managed competing priorities in a previous role.

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Can you discuss your experience with regulatory submissions?

Talk about your familiarity with regulatory requirements and submission processes. Provide specific examples of submissions you've worked on, what your role involved, and how you ensured adherence to regulations.

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What techniques do you use to mentor junior staff?

Share your approach to mentorship, focusing on building trust and providing constructive feedback. Offer examples of how you've helped junior staff improve their skills and knowledge in the industry.

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How do you approach training investigational site staff?

Talk about your training methodology, highlighting the importance of tailoring your approach to the individuals involved. Discuss techniques such as hands-on demonstrations, clear documentation, and follow-up assessments.

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What do you believe are the key qualities of an effective Clinical Research Associate?

Identify essential qualities such as attention to detail, strong communication skills, problem-solving abilities, and adaptability. Provide examples of how you embody these qualities in your work.

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Describe a time you faced a significant challenge in a clinical trial and how you overcame it.

Use the STAR method (Situation, Task, Action, Result) to structure your response, providing a clear narrative of the challenge, your specific role, the steps you took to address it, and the positive outcome.

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Why are you interested in working for Ergomed as a Clinical Research Associate II/SCRA?

Discuss your alignment with Ergomed's values, such as prioritizing employee well-being, dedication to quality, and commitment to making a positive impact on patients' lives. Highlight what excites you about the company and the role.

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Founded in 1997, Erogmed is a global provider of clinical trial planning, management, and monitoring; and drug safety and medical information services. The company offers clinical development, trial management, and pharmacovigilance services for p...

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Full-time, remote
DATE POSTED
November 28, 2024

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