Clinical Trial Coordinator II
On-siteBuenos Aires, Buenos Aires F.D., Argentina
Job Summary
Coordinate assigned trial activities according to task matrices, perform file reviews for departmental, internal, and investigator compliance, and document findings in appropriate systems. Process documents for electronic Trial Master File (eTMF), distribute communications, track local regulatory documents, and reconcile study metrics. Support site activation by coordinating feasibility assessments, developing site lists, and maintaining vendor trackers while ensuring accurate database status. Assist with regulatory submissions, translation QC, and meeting logistics, including taking notes at kick-off meetings and scheduling internal and client sessions. Act as a local expert to gather site knowledge bases, conduct phone interviews for trial optimization, and train new personnel on processes and systems.
Required Qualifications
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
- Ability to work in a team or independently, as required
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete the organizations clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Fluency in local language as well as a good command of the English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Basic organizational and planning skills
- Basic knowledge of local health systems
- Ability to attain and maintain a working knowledge of GCP and applicable SOPs
- Excellent customer focus
- Proven flexibility and adaptability
- Ability to work in a matrix environment
- A proven relationship builder
- An independent thinker
- Ability to manage risk and perform risk escalation appropriately
- Occasional drives to site locations
- Potential Occasional travel required
Desired Qualifications
- Bachelor's degree preferred
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