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Crc - Protocol Writing

0-2 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: M.Pharm/ Pharm.D/ PhD 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

CRC - Protocol Writing

Location: Coimbatore, Tamil Nadu, India
Employer: BDR Pharmaceuticals

Job Overview:

BDR Pharmaceuticals is seeking a CRC (Clinical Research Coordinator) to focus on protocol writing. This role will involve literature surveys, preparing biostudy protocols, coordinating with investigators, responding to sponsor queries, and ensuring regulatory compliance.

Key Responsibilities:

  • Conduct literature surveys to prepare synopsis and protocols per regulatory guidelines.
  • Draft and finalize biostudy protocols based on the synopsis.
  • Coordinate with investigators for protocol finalization.
  • Respond promptly to sponsor queries.
  • Prepare protocol amendments as needed.
  • Keep documentation updated for regulatory submissions.
  • Oversee SOP revisions and implementation in collaboration with QA.
  • Ensure smooth workflow by coordinating with other departments (clinical, bioanalytical, and QA).

Preferred Qualifications:

  • Doctorate or Master's degree in Pharmacy (M.Pharma, Ph.D., or equivalent).

Desired Skills:

  • Knowledge of Good Clinical Practice (GCP).
  • Expertise in clinical research protocol designing.

Job Type:

  • Full-Time, Permanent.

Schedule:

  • 5th February to 8th February, 2:00 PM to 5:30 PM.

Contact:

  • Prabhakaran R
  • Location: Spinos Life Science and Research Pvt Ltd, Krishna Madura Vanam, Vellakinar Pirivu, 29 A, First St, Sri Murugan Nagar, Thudiyalur, Tamil Nadu 641029.