Position Summary:
The Research Coordinator is responsible for coordinating multiple research protocols and serving as a liaison between investigators, sponsors, and site personnel. Under supervision, this role develops a foundational understanding of research operations, compliance standards, and human subject research regulations.
Key Responsibilities:
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Coordinate daily operational activities across multiple research studies.
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Serve as the primary contact between site research teams, sponsors, and supervisors.
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Collaborate with internal departments such as finance, administration, and the local IRB.
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Manage study timelines from feasibility submission through study closeout.
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Review study design, inclusion/exclusion criteria, and ensure accurate informed consent.
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Maintain data integrity through detailed source document review and accurate data entry.
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Create study-specific documentation tools when not provided by sponsors.
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Manage shipment tracking for drugs, devices, and study supplies.
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Document and report adverse events, deviations, and protocol violations.
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Attend investigator meetings, site visits, and clinical research coordinator (CRC) meetings.
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Review and address monitoring or audit findings in collaboration with supervisors.
Qualifications:
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Bachelor's degree in a scientific, healthcare, or related field preferred, or equivalent combination of education and experience.
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Certified Clinical Research Coordinator (CCRC) certification preferred.
Knowledge & Skills:
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Working knowledge of organizational policies and research procedures.
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Basic understanding of ICH guidelines, CFR regulations, and medical terminology.
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Strong communication, organizational, and time management skills.
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Proficiency in routine clinical trial procedures such as ECGs, phlebotomy, specimen handling, and shipping.
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Meticulous attention to detail and ability to manage multiple priorities.
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Self-motivated with strong interpersonal and problem-solving abilities.
Additional Requirements:
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Must adhere to the organization's Code of Conduct and Mission & Values.
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Completion of assigned training modules by designated deadlines.
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Demonstrate competency in required clinical tasks (e.g., ECG, specimen processing), with ongoing evaluation and training as needed.
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