Clinical Research Associate 2

Emerald Clinical

Clinical Research Associate 2 at Emerald Clinical Trials managing site operations and trial monitoring. Coordinate site evaluations, compliance, and training to ensure successful trial outcomes.

Posted 7/25/2026full-timeBangalore • 🇮🇳 IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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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 ManagementOn-Site Monitoring ExperienceICH-GCP Guidelines KnowledgeNegotiation and Conflict ResolutionSite Start-Up Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site SelectionMonitoring ActivitiesRegulatory Package PreparationBudget NegotiationTrial Master File ManagementRisk ManagementQuality ManagementScientific ConceptsClinical Research DesignSupply Management

Soft Skills

Interpersonal CommunicationPresentation SkillsCritical ThinkingProblem-SolvingFlexibility

Tools & Technologies

Clinical Trial Management SystemMonitoring ToolsProject-Specific Documents

Industry Keywords

Clinical TrialsOncologyEthics CommitteeCROPharmaceutical Environment

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience.
Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role.
Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients.