SR CRA (LEVEL I)
Descrição da oferta de emprego
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.
.
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 subjects rights, well-being and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Qualifications.
Education and Experience.
Bachelor's degree in a life sciences related field or a Registered Nursing certification or 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 a clinical research monitor).
Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities.
Effective clinical monitoring skills; 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 mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manages Risk Based Monitoring concepts and processes Effective oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Effective interpersonal skills Strong attention to detail Effective organizational and time management skills Ability to remain flexibile and adaptable in a wide range of scenarios 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 Good English language and grammar skills Good presentation skills
Detalhes da oferta
- Indeterminado
- Em todo o Brasil
- Indeterminado - Indeterminado
- Indeterminado
- 16/04/2024
- 15/07/2024
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