MAIN PURPOSE OF THE ROLE
Individual contributor that works under limited supervision.
Applies subject matter knowledge.
Requires capacity to understand specific needs or requirements to apply
skills/knowledge.
MAIN RESPONSIBILITIES
• Plans, directs, creates and communicates clinical study time-lines.
• Gathers input from cross-functional teams and creates plans that help the team
produce deliverables on schedule.
• Ensures consistency of clinical study and processes across clinical trials.
• Oversees and resolves operational aspects of clinical trials in conjunction
with project teams and in accordance with standard
operating procedures (SOP), good clinical practice (GCP) and specific country
regulations such as site and vendor selection, preparing clinical trial budgets.
• Ensures study is conducted within clinical trial protocols.
• Monitors progress and follows up with team members and line managers when
issues develop.
Qualifications: Required:
* A Bachelor’s degree from an accredited university or college with an academic
focus in medicine,
pre-medicine, nursing, life science, bioengineering, or a
related academic field.
* Minimum two years of clinical research experience.
* Understanding of medical terminology.
* Solid written and verbal communication, interpersonal, presentation and
organizational skills. Has the ability to interpret basic safety data to meet
deadlines as well as the ability to communicate effectively with all levels
of employees.
* The ability to generally work independently but seek guidance when necessary.
* The ability to exchange straightforward information, ask questions and check
for understanding.
* The ability to achieve thoroughness and consideration when accomplishing a
task.
* Must be proficient in Microsoft Office Suite and relevant clinical
applications.
Qualifications: Desired:
* A general familiarity with clinical trials research processes.
* Previous related experience in research within a clinical or