Sr CRA (Level I)

Job Description

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 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