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Key Responsibilities and Required Skills for Clinical Data Coordinator

💰 $55,000 - $80,000

Clinical ResearchData ManagementHealthcare

🎯 Role Definition

The Clinical Data Coordinator is the operational owner for day-to-day clinical trial data activities at the study and site level, ensuring completeness, accuracy and regulatory compliance of trial datasets. This role coordinates data capture in electronic data capture (EDC) systems, manages queries and source data verification (SDV), supports safety and adverse event reporting, performs routine quality control and reconciliation tasks, and liaises with clinical sites, monitors, data managers and cross-functional study teams to prepare databases for interim reviews and final database lock. The ideal candidate is proficient with common EDC platforms (Medidata Rave, REDCap, Oracle Clinical, OpenClinica, Veeva), understands ICH-GCP and regulatory expectations, and can balance rapid turnaround of queries with meticulous documentation for audit-readiness.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Assistant (CRA) or Clinical Trial Assistant (CTA)
  • Research Nurse or Study Coordinator with site experience
  • Data Entry Specialist / Data Analyst supporting clinical studies

Advancement To:

  • Senior Clinical Data Coordinator / Lead Data Coordinator
  • Clinical Data Manager / Data Management Lead
  • Clinical Project Manager or Clinical Operations Manager

Lateral Moves:

  • Clinical Research Coordinator (CRC) at investigator sites
  • Regulatory Affairs Associate
  • Safety/Pharmacovigilance Specialist

Core Responsibilities

Primary Functions

  • Serve as the primary operational contact for study-level data activities, managing timely and accurate data entry, validation and adjudication across multiple sites within the EDC (e.g., Medidata Rave, REDCap, Oracle Clinical, OpenClinica).
  • Design, test and implement eCRFs and data capture forms in collaboration with Data Management and CRAs, ensuring fields align with the protocol, source documents and data validation requirements.
  • Execute routine source data verification (SDV) and data reconciliation between source documents and the EDC to confirm data integrity and flag discrepancies according to the study monitoring plan.
  • Monitor and manage data queries from initial generation to timely resolution, communicating with site staff and monitors to obtain clarifications, corrections and supporting documentation; document all query resolutions in the study database.
  • Perform ongoing quality control (QC) and discrepancy management activities, run automated edit checks and manual reviews, triage high-priority data issues and escalate unresolved problems to Clinical Data Management.
  • Reconcile clinical trial data across systems (EDC, eCRF, IVRS/IWRS, laboratory/vendor data, ePRO and safety databases) to ensure consistency and completeness prior to interim analyses and database lock.
  • Support expedited safety reporting and adverse event documentation by ensuring timely capture of SAE/AE data, accurate MedDRA and WHO Drug coding, and coordination with Pharmacovigilance teams for follow-up and regulatory reporting.
  • Maintain an auditable trail of data changes, data queries and sign-offs; prepare and maintain study-specific data logs, reconciliation worksheets and query trackers for regulatory inspection readiness.
  • Prepare and deliver data extracts, listings and specific datasets for monthly reviews, DSMB meetings, interim analyses and sponsor requests in compliance with data transfer agreements and standards (CDISC/SDTM/ADaM where applicable).
  • Coordinate with clinical monitors, CRAs and site staff to support site initiation, training and ongoing training on EDC procedures, data entry standards, and data quality expectations.
  • Support database build verification, perform User Acceptance Testing (UAT) and document results for release to production, ensuring data fields and edit checks behave as specified in the Data Management Plan.
  • Manage study-specific documentation in electronic Trial Master File (eTMF), ensuring data-related documents (data validation plans, edit check specifications, data clarification logs) are current and filed according to sponsor and regulatory requirements.
  • Track and report data cleanliness metrics and Key Performance Indicators (KPIs) such as query aging, open query counts, SDV completion and database lock readiness to study management and stakeholders.
  • Work with external vendors (central labs, imaging, ePRO providers, IVRS/IWRS) to validate data transfers, reconcile vendor data against EDC entries, and troubleshoot interface issues or mismatches.
  • Assist in the development and maintenance of standard operating procedures (SOPs) and process documentation for data entry, query resolution and database management to drive consistency and compliance across studies.
  • Support study close-out activities including final data reconciliation, database lock activities, dataset submission preparation and archiving of data management documentation.
  • Participate in monitoring visits and audits as the data representative, answer data-related audit findings, and implement corrective and preventive actions (CAPAs) when required to address data quality issues.
  • Maintain up-to-date skills on regulatory guidance (ICH-GCP, 21 CFR Part 11 where applicable) and implement compliance measures for electronic records, signatures and data security.
  • Assist with ad-hoc data requests from clinical operations, biostatistics and medical writing teams, providing data listings, reconciliations and clarifications needed for clinical study reports and regulatory submissions.
  • Facilitate cross-functional communication between clinical teams, data management, safety, and biostatistics to ensure data requirements are understood, timelines are met, and deliverables are produced to specification.
  • Provide mentorship and training to junior data staff and contractors on data standards, query management workflows and site communication best practices to improve team performance and data quality.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis in partnership with biostatistics and clinical operations; prepare ad hoc listings and summary tables for interim review.
  • Contribute to process improvement initiatives and continuous improvement of data workflows and quality assurance approaches across the clinical data team.
  • Participate in study start-up and feasibility activities by advising on data capture feasibility, EDC configuration needs and anticipated data management workload.
  • Assist in vendor selection and oversight, providing input on data transfer specifications, validation needs and deliverable acceptance criteria.
  • Support regulatory and inspection readiness by preparing data management artifacts, responding to inspection queries and implementing CAPAs for data-related findings.
  • Maintain and update training materials and SOPs related to data entry, coding conventions (MedDRA/WHO Drug) and query resolution for distribution to sites and internal stakeholders.
  • Help manage investigator payment or milestone tracking data when required, working with clinical operations and finance teams to ensure accurate deliverables tracking.
  • Participate in cross-functional project meetings and agile/sprint planning when data deliverables are part of iterative study development cycles.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven experience with industry-standard EDC platforms: Medidata Rave, REDCap, Oracle Clinical, OpenClinica, Veeva EDC.
  • Strong knowledge of ICH-GCP, 21 CFR Part 11 requirements and clinical trial regulations affecting electronic data capture and audit trails.
  • Experience running and interpreting automated edit checks, discrepancy reports and validation scripts; ability to author and test edit checks.
  • Proficient with clinical coding dictionaries and standards: MedDRA coding for adverse events and WHO Drug or ATC coding for concomitant medications.
  • Hands-on experience with data reconciliation across multiple systems (EDC, central labs, ePRO, IVRS/IWRS) and ability to resolve mismatches.
  • Familiarity with CDISC standards (SDTM/ADaM) and working with data teams to prepare datasets for analysis and regulatory submission.
  • Practical skills in data extraction and manipulation tools: SQL, Excel (advanced: pivot tables, VLOOKUP/XLOOKUP, Power Query), and experience collaborating with SAS or R/ Python users for data deliverables.
  • Experience with eTMF management and document filing conventions related to data management artifacts.
  • Track record of performing SDV/SDR procedures or supporting monitors during data verification activities at study sites.
  • Ability to prepare data listings, reconciliation tables, and interim datasets suitable for DSMB reviews, interim analyses and clinical study reports.
  • Knowledge of safety reporting workflows and the interface between EDC and safety databases for SAE reconciliation and expedited reporting.

Soft Skills

  • Exceptional attention to detail and commitment to data accuracy; methodical approach to identifying root causes of discrepancies.
  • Strong verbal and written communication skills to interact professionally with site staff, monitors, vendors and cross-functional teams.
  • Time management and prioritization skills to handle competing deadlines across multiple studies simultaneously.
  • Problem-solving orientation with the ability to escalate appropriately and drive resolution across functional boundaries.
  • Collaborative team player who can train and mentor junior staff while coordinating activities between clinical and data teams.
  • Adaptability and continuous learning mindset to adopt new EDC tools, regulatory changes and data standards quickly.
  • Customer service focus and responsiveness when supporting investigative sites and internal stakeholders.
  • Integrity and confidentiality when handling protected health information (PHI) and trial data in compliance with HIPAA and local privacy laws.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Life Sciences, Nursing, Health Informatics, Public Health, Biostatistics, or a related field.

Preferred Education:

  • Master's degree in Clinical Research, Public Health, Health Informatics, or a related discipline.
  • Professional certifications (e.g., ACRP Clinical Research Coordinator, SoCRA, CDM certificate) are advantageous.

Relevant Fields of Study:

  • Nursing
  • Biology / Biomedical Sciences
  • Public Health / Epidemiology
  • Health Informatics / Data Science
  • Biostatistics / Clinical Research

Experience Requirements

Typical Experience Range:

  • 1–4 years of clinical research or data management experience, including hands-on EDC use and query management.

Preferred:

  • 3+ years supporting phase I–III clinical trials or multicenter studies with demonstrated experience in Medidata Rave, Oracle Clinical or REDCap, experience with SDV/SDR, and exposure to CDISC or regulatory submission datasets.
  • Prior site experience (Clinical Research Coordinator) or experience working directly with clinical monitors is a strong plus.
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