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Key Responsibilities and Required Skills for Clinical Trials Associate

💰 $55,000 - $85,000

Clinical ResearchClinical OperationsHealthcareLife Sciences

🎯 Role Definition

The Clinical Trials Associate (CTA) supports clinical study conduct and site management across phase I–IV trials, ensuring regulatory compliance, accurate study documentation, and high-quality data capture. The CTA collaborates with Clinical Research Associates (CRAs), study teams, investigators, and vendors to execute monitoring activities, manage trial master file (TMF) documentation, and facilitate timely study milestones while maintaining ICH-GCP and sponsor SOP adherence.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator (CRC) or Research Nurse
  • Research Assistant / Laboratory Technician
  • Regulatory Affairs or Data Coordinator

Advancement To:

  • Clinical Research Associate (CRA)
  • Senior Clinical Trials Associate or Study Start‑Up Specialist
  • Clinical Project Manager / Clinical Trial Manager

Lateral Moves:

  • Clinical Data Manager
  • Regulatory Affairs Specialist
  • Study Start-up or Site Activation Coordinator

Core Responsibilities

Primary Functions

  • Conduct and document routine monitoring support activities under the direction of the Clinical Research Associate, including site communications, tracking open action items, and preparing monitoring visit materials to ensure protocol adherence and regulatory compliance.
  • Maintain and reconcile Trial Master File (TMF) and Investigator Site Files (ISF) by creating, indexing, filing, and quality-checking essential regulatory documents in accordance with sponsor SOPs and DIA/TMF reference model.
  • Prepare, review and distribute monitoring visit reports, follow-up letters, and close-out documentation, ensuring all findings are clearly captured, risk-ranked, and assigned to appropriate stakeholders for resolution.
  • Coordinate and track informed consent documentation and version control, ensuring that consent forms on file match the approved IRB/IEC materials and that consent processes are documented per GCP.
  • Execute regulatory document collection and submission activities, including site regulatory binders, CVs, medical licenses, and IRB/IEC correspondence to support study start-up and ongoing compliance.
  • Support site initiation, routine monitoring, and close-out visit logistics — scheduling, agenda preparation, source document review plans, and post-visit follow-up to maintain study timelines and budget forecasts.
  • Perform source data verification (SDV) and discrepancy management support in EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva) under supervision, identifying data queries and working with site staff and data managers to resolve issues.
  • Generate, track, and manage data queries and query resolution workflows; ensure timely responses from sites and document resolution steps in the study tracking systems.
  • Assist with serious adverse event (SAE) and safety reporting logistics: collect source documentation, verify timelines, and coordinate with pharmacovigilance teams to ensure required expedited reporting and regulatory communication.
  • Maintain study trackers and dashboards (enrollment, screening logs, lab kit shipments, investigational product accountability) to provide real-time status updates to CRAs and study managers.
  • Support investigational product (IP) accountability and shipment processes, including reconciliation of IP logs, temperature excursion reporting, and coordination of resupply requests with logistics vendors.
  • Coordinate vendor interactions and work with central laboratories, imaging vendors, and IVRS/IWRS providers to track sample shipments, lab kit inventory, and data receipt for monitoring follow-up.
  • Assist with monitoring visit preparation by compiling source documents, regulatory files, lab reports, and query logs to optimize on-site visit efficiency and reduce CRA on-site time.
  • Reconcile enrollment and eligibility checklists against protocol requirements and demographic source documentation, flagging deviations and working with sites to implement corrective actions.
  • Maintain and update study-specific documentation in CTMS (e.g., Veeva, Clintracker) to ensure visit milestones, monitoring plans, and action items are accurate and auditable.
  • Support study start-up activities such as site feasibility assessments, contract and budget tracking support, and facilitation of IRB submissions and communications.
  • Conduct quality control reviews of study binders, eCRFs, and monitoring logs to identify missing documentation or process gaps prior to monitoring visits or audits.
  • Participate in internal cross-functional meetings and status calls, presenting site readiness updates and follow-up actions to study teams and project leads.
  • Provide training and mentorship to study site staff on documentation expectations, EDC basic functions, and protocol-specific processes to improve data quality and trial conduct.
  • Assist with audit and inspection readiness by collating required documentation, responding to document requests, and helping to implement corrective and preventive actions (CAPAs).
  • Track and document protocol deviations and violations, assist with root cause analysis, and support the development and monitoring of corrective action plans to reduce recurrence.
  • Support data anonymization and transfer activities for interim analyses and submission packages, coordinating with data managers to ensure subject confidentiality and data integrity.

Secondary Functions

  • Support ad-hoc site escalations and investigational product logistics during study execution, liaising with clinical supplies, logistics, and vendor teams to maintain continuity of care.
  • Assist with continuous improvement projects for monitoring efficiency and TMF quality, including SOP updates, template enhancements, and automation opportunities.
  • Contribute end-user feedback for EDC and CTMS configuration changes, participating in UAT (user acceptance testing) and training rollouts for study teams and sites.
  • Provide operational support for patient recruitment tracking and retention initiatives, compiling enrollment metrics and flagging sites requiring intervention.
  • Help prepare materials and summaries for investigator meetings, study team training sessions, and cross-functional governance reviews.

Required Skills & Competencies

Hard Skills (Technical)

  • Thorough knowledge of ICH-GCP guidelines and experience applying GCP principles in clinical trial documentation and site interactions.
  • Proficiency with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle InForm, Veeva eTMF, or similar platforms for SDV and query management.
  • Experience using Clinical Trial Management Systems (CTMS) — e.g., Veeva, ClinTracker, or Oracle CTMS — for visit planning, TMF tracking, and milestone reporting.
  • Strong understanding of regulatory submissions, IRB/IEC processes, and essential documents required for study start-up and ongoing compliance.
  • Practical experience with source data verification (SDV), discrepancy management, and query resolution workflows.
  • Familiarity with SAE and safety reporting processes and timelines, and coordination with pharmacovigilance or safety teams.
  • Working knowledge of clinical operations workflows: site initiation, monitoring, close-out, investigational product accountability, and sample logistics.
  • Proficiency with Microsoft Office suite (Word, Excel, PowerPoint) and experience building trackers, pivot tables, and status dashboards.
  • Basic understanding of coding dictionaries and data standards (MedDRA, WHO Drug, CDASH) and how they interface with clinical data management.
  • Experience with TMF/eTMF management and the DIA reference model for essential document indexing and metadata standards.
  • Ability to read and interpret clinical protocols, informed consent forms, and investigator brochures to identify key site responsibilities.

Soft Skills

  • Excellent verbal and written communication skills suitable for interacting with site personnel, investigators, and cross-functional teams.
  • Strong attention to detail and a rigorous approach to documentation, quality control, and follow-through on action items.
  • Time management and organizational skills, with the ability to manage multiple studies or tasks concurrently in a fast-paced environment.
  • Problem-solving mindset and the ability to escalate and resolve site issues proactively with minimal supervision.
  • Team player with collaborative attitude; able to build rapport and influence site staff and internal stakeholders.
  • Adaptability to changing priorities, study demands, and regulatory requirements.
  • Professionalism and ethical judgment when handling confidential subject and trial data.
  • Customer-service orientation with a focus on supporting investigative sites to enhance compliance and performance.
  • Analytical thinking and basic data literacy to interpret enrollment metrics and monitoring KPIs.
  • Cultural sensitivity and ability to work across multi-site, multi-national teams when applicable.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in life sciences, nursing, pharmacy, public health, or related field.

Preferred Education:

  • Bachelor’s or Master’s degree in Nursing, Biology, Pharmacology, Clinical Research, or related scientific discipline.
  • Clinical certifications (e.g., ACRP, SOCRA) or GCP training certificates preferred.

Relevant Fields of Study:

  • Nursing
  • Biology / Biomedical Sciences
  • Pharmacy or Pharmacology
  • Public Health / Clinical Research

Experience Requirements

Typical Experience Range:

  • 0–3 years clinical research or healthcare experience; entry-level to early-career.

Preferred:

  • 1–2 years direct experience supporting clinical trials (site or sponsor side), experience with EDC/CTMS tools, and demonstrated knowledge of GCP and regulatory documentation processes.
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