Clinical Research Associate - Mumbai, Maharashtra, India - Fortrea

Fortrea

Verified Company

Mumbai, Maharashtra, India

1 week ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:
Site management responsibility for clinical studies according to Fortrea's 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 Fortrea's 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.

protocol requirements are adhered to alongside applicable regulatory requirements.

Safeguards data integrity by careful source document review, source document verification,

query generation, and resolution against established data review guidelines on Fortrea 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.

Qualifications (Minimum Required):

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements

Experience (Minimum Required):

A minimum of 2 years of Clinical Monitoring experience.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea 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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