Clinical Research Associate Jobs – Biological E

Biological E is hiring a Clinical Research Associate (CRA) for its Clinical Development team in Hyderabad.
The position is open to professionals with 4+ years of total experience, including experience as both a Clinical Research Coordinator and Clinical Research Associate/Monitor.
Candidates with B.Pharm, M.Pharm or a Master’s degree in Life Sciences can apply.
The role involves clinical trial site management, monitoring, regulatory compliance, investigator training and 50–60% travel.

Clinical Research Associate – Clinical Development

Job Details

• Company: Biological E
• Position: Clinical Research Associate
• Department: Clinical Development
• Location: Hyderabad, Jubilee Hills
• Openings: 1
• Experience: 4+ years total
• Employment Type: Full-time, Permanent
• Industry: Pharmaceutical & Life Sciences
• Role Category: Pharmaceutical & Biotechnology

Eligibility & Qualifications

Educational Qualification

• B.Pharm
• M.Pharm
• Master’s in Life Sciences

Experience

The source specifically requires:

• 4+ years of total experience
• Minimum 2+ years of experience as a full-time Clinical Research Coordinator
• Minimum 2+ years of experience as a Clinical Research Associate / Monitor

Clinical Research Associate – Key Responsibilities

Clinical Trial Site Management

• Act as a communication link between the Sponsor and the site.
• Support the design of study tools, essential clinical documents and processes.
• Perform Site Identification and conduct feasibility studies.
• Conduct Site Selection Visits and Site Initiation Visits according to the protocol and applicable regulatory guidelines.
• Conduct Site Monitoring Visits and Site Close-Out Visits according to the protocol and applicable regulatory guidelines.
• Send follow-up letters to sites and submit visit reports to the Clinical Team Leader / Project Manager as required.

Subject Recruitment & Site Coordination

• Maintain close association with clinical trial sites for:

  • Subject recruitment
  • Subject follow-up
  • Protocol-related activities

• Maintain accurate and timely sponsor/site correspondence and communication.
• Update the reporting authority regarding study status.

Investigator Training & Study Meetings

• Prepare training materials.
• Coordinate with study sites for the successful conduct of Investigator Meetings.
• Train investigators on the protocol and applicable regulatory guidelines.

Regulatory & Ethics Committee Activities

• Provide facilitation and documentation support for Ethics Committee submissions.
• Assist the clinical team in preparing the Regulatory Binder.
• Ensure compliance with applicable clinical research regulatory requirements, including ICH-GCP and CDSCO guidelines.

Clinical Documentation & Trial Master File

• Maintain updated Site Files.
• Collect essential documents and project-related documents during site visits.
• Support maintenance of the Trial Master File (TMF).
• Perform eCRF verification according to project instructions.
• Coordinate and distribute Clinical Study Material to study sites.
• Archive study documents appropriately.

Required Skills

• Strong knowledge of applicable clinical research regulatory requirements.
• Knowledge of ICH-GCP and CDSCO guidelines.
• Strong clinical research and site monitoring skills.
• Proficiency in:

  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint

• Strong written and verbal communication skills.
• Good command of the English language.
• Strong organizational and problem-solving skills.
• Effective time management skills.
• Willingness to travel extensively.

Travel Requirement

The position involves approximately 50–60% travel.

Eligible Qualification Courses

B.Pharm | M.Pharm | Master’s in Life Sciences

Location & Work Details

Location: Jubilee Hills, Hyderabad
Department: Clinical Development
Employment: Full-time, Permanent
Openings: 1
Experience: 4+ Years
Travel: 50–60%

How to Apply

Interested and eligible candidates can apply through the job posting.

Apply for Clinical Research Associate – Biological E

Job Summary