Clinical Research Coordinator

We are looking for a candidate who will be assisting investigators in conducting clinical trials and/or clinical research studies at the National Neuroscience Institute, in adherence to Good Clinical Practice (GCP) Guidelines, protocol requirements, and other applicable regulatory and ethical guidelines, SOPs and hospital policies.

Key Responsibilities:

• Plan, manage and conduct clinical trials from study start-up, perform study-related activities, such as screening and recruitment of study subjects; assist with obtaining informed consent; coordination of subject visits; data entry and other procedures, to study closure.
• Assist in IRB and/or regulatory application submissions.
• Collect, handle and process specimens in accordance with the protocol/lab manual.
• Take vital signs and ECG recordings.
• Maintain the Investigator Site Files and ensure all study documents are accurate, complete and up-to-date.
• Manage Investigational Products.
• Assist in adverse events reporting.
• Administer study-related questionnaires.
• Draft and manage study budgets and timelines, and prepare billing documents to sponsors.
• Conduct study monitoring visits for IITs.
• Train and mentor junior staff.
• Work closely with internal and external stakeholders to ensure all study-related activities are carried out efficiently.

Requirements:

• Bachelor’s degree in Life Sciences, Nursing, or related fields. Candidates with at least 4 years of clinical trial experience is preferred.
• Strong knowledge of GCP guidelines and regulatory requirements.
• Good written, communication and interpersonal skills. Ability to speak other languages will be an added advantage.
• Strong organisational, time management and problem-solving skills.
• Meticulous and able to work independently.
• Good team player.
• Proficient in Microsoft applications.
• Prior experience in monitoring would be most advantageous.