Cra - Fsp

2+ years

Not Disclosed

Bangalore

10 March 19, 2025

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 Title: Clinical Research Associate (CRA)
Company: Parexel
Location: [Insert Location]

About Parexel:
At Parexel, as a Clinical Research Associate (CRA), you play a crucial role in advancing treatments to patients faster. Your primary responsibility is the safety and well-being of patients. By traveling to investigator sites and performing monitoring duties, you'll help ensure clinical trials are conducted efficiently and safely, building strong relationships and solving problems along the way.

Join our global team and work on a wide variety of therapeutic areas. We are seeking passionate individuals who are ready to grow personally and professionally, contributing to global projects and supporting cross-functional teams.

Success Profile:
To succeed at Parexel, you should have the following traits:

Strong communicator
Detail-oriented
Flexible and adaptable
Organized and efficient
Problem solver
Self-starter with initiative

About This Role:
As a CRA at Parexel, you will be responsible for managing clinical trial sites from initiation to close-out. Your role will involve ensuring that study protocols are followed, issues are resolved, and the site meets all regulatory and training requirements. You will collaborate with the study team, providing critical support to sites while ensuring high-quality data and regulatory compliance.

Key Responsibilities:

Site Maintenance:
- Act as the primary point of contact between Parexel and assigned sites, ensuring compliance with study protocols and regulatory requirements.
- Resolve issues at sites, including training, documentation deficiencies, and communication problems.
- Monitor site staff assignments and ensure they align with project needs, implementing corrective actions when necessary.
- Review, approve, and maintain site documentation (e.g., regulatory documents) in accordance with project requirements.
- Evaluate site recruitment plans and provide strategies for improvement.
- Conduct on-site visits (Qualification, Initiation, Follow-up) and remote visits when necessary.
Data and Documentation Management:
- Ensure timely and accurate data entry in Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and other relevant platforms.
- Maintain the Trial Master File (TMF) for all sites, ensuring it is complete and audit-ready.
- Follow up on CRF data entry, query status, and serious adverse events (SAEs).
- Oversee the management of study supplies, including accountability and return/destruction status.
Regulatory Compliance and Quality:
- Monitor and ensure adherence to ICH-GCP guidelines, applicable regulations, and Parexel SOPs.
- Assist in audit preparation and participate in internal/external audits and regulatory inspections.
- Identify and address non-compliance, delays, or issues impacting study timelines, proposing corrective strategies.
Collaboration and Teamwork:
- Work with the project team to meet study milestones and objectives, providing strategies for effective project planning.
- Mentor and guide administrative support teams and provide feedback on their performance.
- Maintain a positive, results-oriented work environment by building collaborative relationships across the team.
- Ensure that assigned sites remain compliant, on schedule, and audit-ready throughout the study lifecycle.

Skills & Qualifications:

Key Skills:
- Strong problem-solving and analytical skills
- Ability to work independently and take initiative
- Advanced presentation and communication skills
- Flexible and client-focused attitude
- Proficient in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), MS Office (Excel, Word), and other clinical trial software
- Strong interpersonal, verbal, and written communication skills
Experience:
- Site management experience or equivalent in clinical research
- Familiarity with clinical trial methodologies and terminology
Education:
- Degree in Biological Science, Pharmacy, or other health-related disciplines (preferred) or equivalent nursing qualification/experience

Physical Demands/Work Environment:

Willingness to travel extensively, depending on the phase of the study
Ability to work in a virtual team environment
Valid driver’s license may be required

Why Parexel?
Parexel is committed to fostering a diverse, inclusive work environment and offers excellent career development opportunities. We encourage all qualified candidates to apply, regardless of race, religion, gender, or other protected characteristics. At Parexel, we value teamwork, innovation, and commitment to quality, ensuring a collaborative and high-performance culture.

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Cra - Fsp

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