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Clinical Research Associate Ii

3 months ago

Navi Mumbai, India Labcorp Full time

Job Summary:

- Site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
- Conducts site monitoring responsibilities for clinical trials according to Labcorp Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
- Prepares and implements project plans related to Clinical Monitoring responsibilities.
- Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Labcorp or client data management systems.
- Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
- Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
- Ensures adherence to global quality control and CRA performance metrics.
- Ensures audit readiness at site level.
- Acts in the project role of a Lead CRA as assigned.

Essential Job Duties:

- Responsible for all aspects of study site monitoring; and other duties, as assigned.
- General On-Site Monitoring Responsibilities:

- Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
- Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
- Ensure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare and submit accurate and timely trip reports.
- Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Labcorp or client data management systems, as assigned by management.
- Assist with the administration of clinical research projects, recruiting investigators (if applicable) collecting investigator documentation and site management.
- Update, navigate, and maintain Labcorp or study/Sponsor-specific trial management tools/e-Clinical systems.
- Track IP shipments and supplies, as needed.
- Track and follow-up on serious adverse events as assigned.
- Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
- Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
- Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
- Present training content for site initiation.
- Assist with training, of new employees (e.g., co-monitoring).
- Perform other duties as assigned by management.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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