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Clinical Research Associate

1+ years
Not Disclosed
4 Dec. 2, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Title: Clinical Data Specialist

Department: Clinical Operations

Location: [Specify Location]

Reporting To: Project Manager


Job Description

Role Overview:

The Clinical Data Specialist is responsible for managing clinical trials, ensuring compliance with protocols, and maintaining data integrity. This role involves trial documentation, data management, regulatory adherence, and active participation in global project discussions to ensure the seamless execution of clinical trials.


Key Responsibilities

Project and Operations Management

  • Manage designated clinical trials, including preparation of trial documentation such as protocols and Case Report Forms (CRFs).
  • Ensure accurate and timely data entry into data collection platforms (e.g., electronic CRFs, Cancer Research Database (CRDB), PC-based systems, remote data entry) as per protocol requirements.
  • Track and organize completed CRFs, ensuring rapid database entry and adherence to timelines.
  • Address and resolve data queries generated during cleaning while ensuring compliance with ICH-GCP guidelines.
  • Monitor trial conduct to ensure adherence to approved protocols and regulatory guidelines.
  • Enhance quality assurance and consistency in electronic data capture processes.
  • Actively participate in global meetings to review progress and provide updates on clinical trials.
  • Conduct protocol monitoring activities and verify compliance with Good Clinical Practices (GCP).
  • Communicate any deviations, violations, safety alerts, or quality issues to the sponsor promptly.
  • Fulfill all regulatory requirements relevant to the clinical trial.

Security Responsibilities

  • Never share passwords with anyone.
  • Ensure systems are locked when not in use.
  • Refrain from using unauthorized applications.
  • Avoid saving Protected Health Information (PHI) on unauthorized domains.

Education and Experience

  • Bachelor’s/Master’s degree with a minimum of 1 year of experience in Clinical Trials Management/Protocols.
  • Alternatively, 6 months of clinical trial experience with certification in Clinical Trials/Research.
  • Preferred: Knowledge of oncology-specific terminology.
  • Strongly preferred: Experience with EDC systems such as Medidata RAVE, Oracle, and Inform.
  • Hands-on experience with industrial protocols and monitoring visits is an advantage.

Skills and Competencies

  • Proficient in clinical data management and trial monitoring activities.
  • Excellent organizational and time management skills.
  • Strong written and verbal communication abilities.
  • Proficiency in computer systems and electronic data capture tools.
  • Ability to multitask, handle pressure, and meet strict deadlines.

Work Details

  • Shift: Flexible or General Shift as per project requirements.
  • Work Mode: Work From Office (WFO).

This role offers an excellent opportunity to contribute to groundbreaking clinical research while developing expertise in trial management and data integrity practices.