Key Responsibilities:

Plan and coordinate all aspects of clinical trials, including protocol development, study design, and site selection.
Identify and qualify potential study sites, and initiate and maintain relationships with investigators and site staff.
Develop and maintain study documents, including protocols, informed consent forms, case report forms, and study manuals.
Monitor study progress and ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP).
Conduct site initiation, interim, and close-out visits, and ensure timely and accurate completion of all study-related activities.
Perform source data verification and review study data for accuracy, completeness, and consistency.
Manage study budgets and ensure timely payment of study-related expenses.
Communicate study updates and issues to internal and external stakeholders, and collaborate with cross-functional teams to resolve any study-related issues.
Prepare and submit study progress reports to regulatory authorities and ethics committees.
Support the preparation of regulatory submissions and responses to regulatory queries.
Participate in the development and implementation of departmental processes and procedures.
Mentor and train junior team members, as needed.

Qualifications:

Bachelor's degree in a life science or related field.
Minimum of 2 years of experience as a Clinical Research Associate or equivalent experience in clinical research.
Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
Excellent organizational, time-management, and problem-solving skills.
Ability to work independently and in a team environment.
Strong attention to detail and ability to prioritize and manage multiple tasks simultaneously.
Excellent communication and interpersonal skills.
Proficiency in Microsoft Office Suite.

If you are looking for a challenging and rewarding career in clinical research, we invite you to apply for this exciting opportunity.

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