Clinical Research Associate

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Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Responsibilities

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subject’s rights, well-being, and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Detailed tasks and responsibilities assigned to the role are outlined in the task matrix.
• Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Provides trial status tracking and progress update reports to the Clinical Research Manager (CRM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. eTMF).
• Participates in investigator meetings as necessary.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Responds to company and applicable regulatory requirements/audits/inspections.
• Gives to other project work and initiatives for process improvement, as required.

Qualifications

• Bachelor’s or Master’s degree in a health or life sciences-related field or an equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as an on-site clinical research monitor, especially in the IVD area).

Knowledge, Skills, Abilities

• Effective clinical monitoring skills & and ability to travel for site activities
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents
• Well-developed critical thinking skills, including but not limited to critical attitude, in-depth investigation for appropriate root cause analysis, and decision-making
• Ability to handle Risk Based Monitoring concepts and processes
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Effective social skills and Strong attention to detail
• Effective organizational and time management skills
• Ability to work in a team or independently as required
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software