Senior Clinical Research Associate

2-4 years

Not Disclosed

Navi Mumbai

10 Oct. 3, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Opportunity: Senior Clinical Research Associate

Department: Delivery
Location: Navi Mumbai
Closing Date: October 21, 2024
Openings: 1
Grade: C1C
Reporting To: Program Manager

Job Responsibilities

Project and Operations Management:

Manage designated clinical trials and prepare trial-related documentation in accordance with protocols and Case Report Forms (CRFs).
Ensure the completeness and timely submission of data into data collection forms, including electronic CRFs and cancer research databases (CRDB).
Track completed CRFs and implement systems for rapid data entry into databases. Address queries generated during data cleaning in compliance with ICH-GCP guidelines.
Ensure that all trials are conducted in accordance with the approved protocol and any amendments.
Improve quality assurance and consistency in electronic data capture.
Participate in global conference calls and meetings to review the progress of ongoing clinical trials.
Maintain proficiency in protocol monitoring activities.
Verify adherence to approved protocols and GCP procedures by investigators.
Communicate any observations regarding protocol deviations, safety alerts, or quality issues to the sponsor.
Complete regulatory requirements as applicable.

Security Responsibilities:

Never share passwords or sensitive information.
Ensure all systems are locked when not in use.
Avoid using unauthorized applications.
Do not store PHI data on the Vasta domain.

Qualifications

Education: Bachelor’s or Master’s degree.
Experience: Minimum of 4 years in Clinical Trials Management or Protocols is preferred.
Knowledge: Familiarity with oncology-specific terminology and experience with EDCs such as Medidata RAVE, Oracle, or Inform is strongly preferred.
Skills:
- Hands-on computer skills.
- Strong written and verbal communication abilities.
- Ability to multitask, work under pressure, and meet deadlines.

If you are a dedicated professional with a passion for clinical research and possess the necessary skills and experience, we invite you to apply for this exciting opportunity!

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Senior Clinical Research Associate

Job Description

Job Opportunity: Senior Clinical Research Associate

Job Responsibilities

Qualifications

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