Metta Clinical Research Hiring For Clinical Research Coordinator (CRC)

A CRC coordinates administrative and clinical activities of trials, managing patient recruitment, ICF, documentation, and regulatory compliance at the site level under the direction of the Principal Investigator.

ICH-GCP is an international ethical and quality standard for designing, conducting, recording, and reporting trials involving human subjects to protect rights and ensure data credibility.

By explaining the trial in lay terms, answering all patient questions, verifying voluntary consent, obtaining signatures and dates before any trial procedure, and giving a copy to the subject.

Document the deviation immediately, notify the PI, implement corrective actions, and report it to the study sponsor and IEC as per timeline regulations to prevent recurrence.

An AE is any untoward medical occurrence. An SAE is any event that results in death, is life-threatening, requires hospitalization, results in persistent disability, or causes a congenital anomaly.

Under standard GCP and Indian regulatory norms, an SAE must be reported to the Sponsor and Ethics Committee within 24 hours of site awareness.

Keep precise logs of receipt, storage temperature, dispensation, return, and disposal, while ensuring IP is stored securely as per protocol temperature requirements.

An ISF contains all essential clinical trial documents (SOPs, protocols, approvals, CVs, logs) required to demonstrate compliance with GCP guidelines and regulatory standards.

Update all CRFs, resolve outstanding queries, organize the ISF, compile all source documents, ensure the PI is available, and prepare the IP storage area for inspection.

SDV is the process where a Monitor compares entries in the CRFs against primary source documents (medical charts, lab results) to ensure accuracy and completeness of data.

Empathize and listen to their concerns, respect their autonomy as clinical trial participation is voluntary, notify the PI, and perform appropriate safety follow-ups.

Review medical history, lab results, and diagnostics against the protocol's inclusion and exclusion criteria to confirm eligibility before enrolling.

Review source documents, correct or clarify the entry in the EDC system, provide appropriate documentation, and close the query in a timely manner.

A document signed by the PI delegating specific clinical trial duties to qualified site staff, ensuring accountability and adherence to protocol tasks.

Many investigational products and biological samples are temperature-sensitive; failing to maintain proper temperature ranges can compromise safety and efficacy data.

Prioritize based on patient visits, regulatory deadlines, and high-impact tasks. Use tracking calendars, task lists, and electronic planners.

Phase I (safety/tolerability), Phase II (efficacy/exploratory), Phase III (confirmatory/therapeutic efficacy), Phase IV (post-marketing surveillance).

To safeguard the rights, safety, and well-being of all trial subjects, review study protocols, ICFs, investigator qualifications, and monitor trial progress.

Follow specific protocol instructions for processing (e.g., centrifugation), store at the designated temperature, use appropriate biohazard packaging, and coordinate courier pickup.

A framework for data integrity: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.

Contact the patient to ascertain the reason, reschedule within the allowed protocol window, document the missed visit, and notify the PI.

Background, objectives, design, inclusion/exclusion criteria, treatment plan, assessment of safety/efficacy, statistical methods, and administrative details.

Use subject identification codes instead of names on all CRF entries, store physical files in locked cabinets, and use password-protected databases.

Establish a positive relationship, explain the value of their contribution, minimize wait times, provide clear schedules, and offer consistent follow-up support.

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