Clinical Research Associate 2

Jobtailor; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Jobtailor in Bengaluru, Karnataka, seeks an experienced Clinical Trial Manager to oversee on-site monitoring and site management across oncology and early-phase trials. You will coordinate investigator identification, site evaluation, regulatory packages, budgets, contracts, and TMF filing to ensure compliance with ICH-GCP and ethical guidelines.

The role requires 2–5 years of on-site monitoring experience in academic, CRO, or pharmaceutical settings, strong negotiation and problem-solving

Qualifications

• tertiary qualification in a related science or health care discipline.
• 2–5 years of on-site monitoring and site management experience in academic, CRO, or pharma.
• Experience in Oncology and/or early-phase trials is a plus.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in negotiation, critical thinking, problem-solving, decision making, and strategic thinking.
• Demonstrate ability to travel and work with a multi-disciplinary team.

Responsibilities

• Coordinate investigator and site identification, feasibility assessment, and site selection.
• Complete monitoring activities per the Monitoring Plan and prepare monitoring visit reports within the timeframe.
• Plan, organize, and conduct site evaluation visits and report findings for site selection.
• Prepare and liaise on regulatory packages, import/export requirements, and Ethics Committee updates.
• Negotiate site budgets, coordinate contract execution, track invoicing, and ensure timely payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain monitoring tools and project documents.
• Motivate and train investigators on protocol, product, and trial requirements.
• Collect and approve essential TMF documents; code for TMF filing and reconcile site files.
• Coordinate distribution and destruction of investigational product and trial supplies.
• Maintain trial information in CTMS and other tracking tools; support recruitment strategies.

Skills

Clinical Trial Management

On-Site Monitoring

ICH-GCP Knowledge

Negotiation

Site Start-Up Management

Education

Related science/healthcare degree

Tools

Clinical Trial Management System

Monitoring Tools

Project-Specific Documents

Job description

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
• Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

Requirements

• Tertiary qualifications in a related science or health care discipline.
• Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory.
• Experience in Oncology and/or early-phase clinical trials is a plus.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
• Ability and willingness to travel.

Core Competencies

Demonstrates expertise in clinical trial management, including site selection, monitoring, and compliance with ICH-GCP guidelines. Proficient in negotiation, problem-solving, and maintaining trial information using clinical trial management systems.

Highest-signal resume keywords

• Clinical Trial Management
• On-Site Monitoring Experience
• ICH-GCP Guidelines Knowledge
• Negotiation and Conflict Resolution
• Site Start-Up Management

ATS Optimization Keywords

Hard Skills

• Site Selection
• Monitoring Activities
• Regulatory Package Preparation
• Budget Negotiation
• Trial Master File Management
• Risk Management
• Quality Management
• Scientific Concepts
• Clinical Research Design
• Supply Management

Soft Skills

• Interpersonal Communication
• Presentation Skills
• Critical Thinking
• Problem-Solving
• Flexibility

Industry Keywords

• Clinical Trials
• Oncology
• Ethics Committee
• CRO
• Pharmaceutical Environment

Tools & Technologies

• Clinical Trial Management System
• Monitoring Tools
• Project-Specific Documents