(Sr.) CRA

Edwards Lifesciences

Multiple Locations, Germany

CRA II or SCRA (ideally with minimum of 3 years experience of monitoring) based in Germany or other environs. Is capable of conducting SIVs, IMVs and COVs independently.

Has a solid working knowledge of the regulatory environment: ISO, MDR and GCP.

Is familiar with maintaining ISFs and the study e TMF.

Background in pharma or medical devices.

Experience in cardiology/cardiac therapy clinical trials.

Responsible for remotely supporting field clinical research associate/site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities:

Organizing and supervising clinical study:
- Assist and conduct Clinical Monitoring activities;
- Serve as key contact to assigned clinical sites throughout the study process;
- Is accountable for achieving and reporting on agreed clinical milestones;
- Supports study team in the interactions with Ethics Committees and Competent Authorities;
- Participates actively to project team meetings, as required;
- Close collaboration with internal stakeholders to ensure proper project conduct;
- Assist in Providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required;
- Reporting site enrollment progress including device accountability and protocol deviations (inclusion/exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.
Processing adverse events:
- Document procedural case observations for insights in investigating post procedural events;
- Data review, safety reporting and complaint handling;
- Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements.
Identifies and supports process improvement opportunities and implementation;
Ensures Audit readiness for internal, external and site Audits;
Other incidental duties as assigned by management.

Education and Experience:

Bachelor's Degree in in related field, 3 years experience of previous related medical device and/or clinical experience Required;
Other: Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred; and
Other: Experience in interventional cardiology or cardiothoracic surgery Preferred.

Additional Skills:

Good computer skills in MS Office Suite and ability to operate general office machinery;
Good written and verbal communication skills, presentation and interpersonal relationship skills;
Good problem-solving and critical thinking skills;
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

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