CRA/ SSU Intern

1.    PURPOSE OF JOB :

• To assist the clinical operation  teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.
   

2.     JOB FUNCTIONS/ RESPONSIBILITIES :

• To be familiar with ICH GCP, appropriate regulations, ICON internal tracking systems.
•  To be familiar with the roles of Clinical Research Associate (CRA) / Study Start up Associate (SSUA).
•  To assist the Clinical Operations teams in completion of all required tasks to meet departmental goals.
• To support the Clinical Operations teams with ongoing conduct of studies.
• To assist Clinical Research Associates (CRAs) and Site with accurately updating and maintaining clinical study tracker.
• To assist the team with submission documentation and guidelines, as appropriate.
• To collate and verify, for completeness, submission documentation for submission to the Regulatory/ Ethical Committee (EC) and other relevant authorities.
• To co-ordinate, dispatch and Track submission to CA/EC and other relevant authorities.
• To assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• To perform assigned administrative tasks to support team members with clinical trial execution.

3.    QUALIFICATIONS/ EXPERIENCE REQUIRED :

• Pharmacy or Science Education background university student
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Attention to detail and accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers and clients