Clinical Study Coordinator/Clinical Research Coordinator

Job Summary:

The Clinical Study Coordinator is responsible for the overall administrative and operational management of clinical trials at the site level, working under the direct supervision of the Principal Investigator (PI). The CRC serves as the central point of contact for the research team, participants, sponsors, and other key stakeholders, ensuring the smooth and efficient conduct of the study in full compliance with the study protocol, Good Clinical Practice (GCP) guidelines, and Philippine regulatory requirements.

Key Responsibilities:

• Study Planning and Start-up:
• Assists the PI in the sponsor's site feasibility process, including finalizing arrangements for site selection visits and ensuring hat all relevant departments are informed of the sponsor/CRO visit evaluating the site's capability to conduct the trial.
• Prepares and submits all required documents to the Institutional Ethics Review Committee (IERC) and other regulatory bodies, as applicable
• Develops and maintains essential trial documents, including the Investigator Site File (ISF), to ensure readiness for study monitoring visits, audits and inspections.
• Participant Management:
• Together with the site study team, designs and implements strategies for participant recruitment and screening, ensuring the timely enrollment of eligible individuals.
• May be assigned to obtain informed consent from potential participants, ensuring they fully understand the study's purpose, risks, and benefits.
• Schedules and coordinates all study visits and procedures, including assessments, laboratory tests, and dispensing of investigational products.
• Monitors participant safety and well-being, promptly reporting any adverse events or serious adverse events to the PI and the sponsor.
• Serves as a liaison for study participants, addressing their questions and concerns throughout the trial.
• Data Management and Quality Assurance:
• Ensures accurate, complete, and timely collection of all study data in Case Report Forms (CRFs) or Electronic Data Capture (EDC) systems.
• Takes initiative to perform own source data verification, comparing data entered into CRFs with source documents (e.g., medical charts, lab reports) in preparation for monitoring visits.
• Resolves data queries and clarifies inconsistencies with the sponsor's Clinical Research Associate (CRA) or data management team.
• Maintains a system for proper storage and archiving of all study-related documents.
• Compliance and Oversight:
• Monitors adherence to the study protocol and GCP guidelines at all times.
• Prepares for and actively participates in monitoring visits, audits, and inspections by sponsors and regulatory authorities.
• Manages the investigational product (drug or device) inventory, including proper storage, accountability, and documentation.
• Manages the trial budget, ensuring all study activities are within financial constraints and expenses are properly documented.

Qualifications and Requirements

Education:

• Required:
   Bachelor's degree in a health-related field such as Nursing, Pharmacy, Medical Technology, Public Health, or a related Life Sciences.

Experience:

• Entry-Level:
   While some positions may be entry-level, a background in a healthcare or research setting (e.g., as a research assistant, nurse, or medical technologist) is highly desirable.
• Mid-Level to Senior:
   Typically requires at least 1-3 years of experience in clinical research or clinical trial management. Experience with specific therapeutic areas (e.g., oncology, cardiology, infectious diseases) is often a plus.

Knowledge and Skills:

• Regulatory Knowledge:
   In-depth knowledge of local and international regulations, including the Philippine FDA's requirements, local IRB guideleines and the ICH-GCP standards.
• Technical Skills:
   Proficiency with clinical trial management systems (CTMS), Electronic Data Capture (EDC) systems, and Microsoft Office Suite.
• Communication:
   Excellent written and verbal communication skills in both English and Filipino.
• Organizational Skills:
   Exceptional organizational and time-management abilities, with a strong attention to detail.
• Interpersonal Skills:
   The ability to build effective working relationships with investigators, participants, and sponsors.
• Problem-Solving:
   Strong critical thinking and problem-solving skills to address challenges that arise during the trial.
• Certification:
   Preferably with an active GCP certification within the last two years.