Logo of Huzzle

Home

Matches

Explore

Manage

Find 50,000+ jobs, internships & events from 6,000+ top companies on Huzzle using AI

Clinical Research Associate

image

Intuitive

3mo ago

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Freiburg im Breisgau
    Remote

AI generated summary

  • You need a relevant degree, 3+ years in clinical monitoring, project management skills, fluency in English (additional European language preferred), travel readiness, and strong IT and communication skills.
  • You will assist in study protocol development, monitor studies, conduct site visits, ensure compliance, manage documentation, and support team training and process improvements.

Requirements

  • Bachelor’s degree in science/health care field or nursing degree.
  • Experience working in medical device industry in the Clinical Affairs/research function with evidence of full monitoring responsibilities for at least three years. Experience of monitoring responsibilities for pre-CE mark European clinical studies is preferred.
  • Ability to manage multiple projects and varied tasks to meet deadlines.
  • English language required and a second European language preferred (French or German).
  • Ability and willingness to travel up to 25% of the time which may include several European countries.
  • Advanced knowledge of clinical research activities essential for both pre-CE and post-CE mark clinical studies.
  • Knowledge of applicable regulations (MDR, GCP, ISO-14155, MEDDEV guidelines, GDPR and applicable local regulations).
  • Strong analytical and problem-solving skills, and flexibility to change.
  • Strong IT skills; including use of eCRF and CTMS for monitoring, analytics, and MS Office tools.
  • Excellent written, verbal communication, and presentation skills.

Responsibilities

  • Assist Clinical Affairs Manager (CAM)/Clinical Affairs Project Manager (CAPM) in protocol development, CRF designs and study documentation preparation for both pre-market and post market clinical studies.
  • Monitoring responsibility for smaller studies.
  • Conduct of on-site initiation visits, routine monitoring visits and closeout visits for both pre- and post-CE Mark studies.
  • Remote clinical database monitoring and query follow up with the Investigational center(s) to address potential data discrepancies.
  • Maintain study documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • Evaluation of the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Trouble-shoot with alignment of the CAPM any compliance issues at sites.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment, and enrollment, CRF completion and data query generation and resolution.
  • Maintains site performance metrics and implements action plans for sites not meeting expectations.
  • Assist in preparation and submission of regulatory packages to ethics committees and/or competent authorities.
  • Support the CAM/CPAM in the management of the study such as development of monitoring tools, source document templates, CRF completion guidelines, Clinical Monitoring Plans.
  • Develop additional study tools specific to the project or sites needs as required.
  • Support EDC testing for newly implemented databases.
  • Introduce Clinical Research Associates new to the position or company.
  • Support process improvement within Clinical Affairs.

FAQs

What is the primary role of a Clinical Research Associate at Intuitive?

The primary role of a Clinical Research Associate at Intuitive is to perform remote on-site or in-house monitoring of clinical research studies, ensuring compliance with applicable regulations and standards throughout the clinical trial process.

What qualifications are required for this position?

A Bachelor's degree in a science/healthcare field or a nursing degree is required, along with at least three years of experience in the medical device industry's Clinical Affairs/research function.

Is experience in clinical monitoring necessary?

Yes, the candidate should have evidence of full monitoring responsibilities for at least three years, with preferred experience in pre-CE mark European clinical studies.

Are there language requirements for this position?

Yes, proficiency in English is required, and a second European language such as French or German is preferred.

Will travel be required in this role?

Yes, the Clinical Research Associate should be willing to travel up to 25% of the time, which may include visits to several European countries.

What type of skills are necessary for success in this role?

Strong analytical and problem-solving skills, flexibility to adapt to change, and strong IT skills, including proficiency in eCRF, CTMS, and MS Office tools, are essential for success.

What type of projects will the Clinical Research Associate work on?

The Clinical Research Associate will work on both pre-market and post-market clinical studies, assisting with protocol development, site management, and monitoring study compliance.

How does Intuitive ensure diversity and inclusion in the workplace?

Intuitive fosters an inclusive culture built around diversity of thought and mutual respect, empowering team members to bring their authentic selves to work.

What kind of support does Intuitive provide for employee growth?

Intuitive actively invests in team members to support their long-term growth, enabling them to advance in their careers and achieve their highest potential.

Are there any specific regulatory knowledge requirements for this position?

Yes, candidates should have advanced knowledge of applicable regulations, including MDR, GCP, ISO-14155, MEDDEV guidelines, GDPR, and applicable local regulations.

image

Intuitive

A global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery.

1-10
Employees
1995
Founded Year

Mission & Purpose

Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.