Sr CRA

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 ( 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