CLINICAL DATA COORDINATOR JOB DESCRIPTION

A Clinical Data Coordinator ensures that case report forms, source documents, and EDC entries are complete, accurate, and audit-ready before sponsors or principal investigators review them. FDA regulatory requirements govern every data point this role touches, and a single unresolved query can stall a study's timeline by weeks. The role sits within the clinical research site team, accountable to the Research Team Leader and answerable to both internal QA and external sponsor representatives. No other contributor owns the full chain from CRF completion to archival sign-off.

As the Clinical Data Coordinator, you maintain the integrity of clinical trial data from initial entry through sponsor closeout, ensuring every case report form and subject folder meets FDA standards and study-specific protocols. The position operates within the site research team, collaborating daily with the principal investigator, project managers, CRAs, and third-party data sources to keep study milestones on track.

Career Impact: Hands-on ownership of CRF lifecycle and QA audit preparation builds the regulatory fluency that distinguishes senior clinical data professionals in a competitive research market.

Business Impact: Accurate, timely data packages directly determine whether sponsor reviews proceed on schedule and whether study findings hold up under regulatory scrutiny.

Growth Opportunity: The cross-functional exposure - spanning site operations, sponsor relations, and database validation - creates a direct path toward Clinical Research Associate or Data Management Specialist roles.

• Review protocol and case report forms to determine study-specific data requirements and flag gaps for resolution with the Team Leader.
• Complete and submit study CRFs accurately and on schedule to meet sponsor requirements and FDA documentation standards.
• Conduct data review and query generation, tracking open items through to resolution with appropriate site staff.
• Reconcile data from third-party sources, including lab feeds, with the clinical study database and escalate discrepancies promptly.
• Maintain study files, subject folders, and archival records in accordance with clinical archival process standards.
• Perform routine audits of study files and security records to verify compliance with clinical standards before QA or sponsor review.
• Generate and distribute status reports to the study team and clinical sites, following up on outstanding action items.
• Support sponsor visits by preparing sponsor rooms and ensuring all CRFs and subject folders are QA-reviewed in advance.

• High school diploma or equivalent required; bachelor's degree in a life sciences or health-related field preferred, or equivalent work experience.
• 2 or more years of clinical research, healthcare, or data management experience, with demonstrated ability to manage concurrent study responsibilities.
• Understanding of clinical research processes, FDA documentation requirements, and GCP regulatory expectations.
• Demonstrated proficiency in data entry accuracy, including ability to type 35 or more words per minute with high precision.
• Strong organizational skills with the ability to maintain multiple subject folders and study timelines simultaneously.
• Effective written and verbal communication skills, with the ability to convey data issues clearly to investigators, sponsors, and project managers.
• Ability to identify discrepancies, escalate problems proactively, and follow through on resolutions without prompting.

• Prior exposure to EDC systems or clinical database environments, with the ability to perform user acceptance testing.
• Familiarity with medical terminology sufficient to interpret protocol language and source document content accurately.
• Experience supporting on-site monitoring visits or sponsor and regulatory audits in a clinical research setting.
• Background in study archiving, CRF completion guidelines development, or cross-functional coordination with CRA teams.

• CRF completion rate, measuring the percentage of forms fully completed and submitted by sponsor deadlines.
• Query resolution cycle time, tracking average days from query generation to closure across active studies.
• Audit-readiness rate, reflecting the proportion of subject folders that pass QA review without requiring rework.
• Sponsor query volume post-study, measuring outstanding data issues remaining at study closeout.
• On-time status report distribution rate, tracking adherence to reporting schedules across assigned study sites.
• Typical tools: Electronic Data Capture platforms (commonly Oracle-based EDC); office productivity suites (commonly MS Word, Excel, PowerPoint).

• Base Salary Range: $42,000 to $62,000 annually, depending on experience and site location.
• Bonus: Typically none at this level; some sites offer modest performance bonuses.
• Equity: Not standard for this role in clinical research settings.
• Health Benefits: Medical, dental, and vision coverage standard across most research organizations.
• PTO: 10 to 15 days annually, plus standard federal holidays.
• Common Perks: Continuing education support, GCP training reimbursement, and flexible scheduling at select sites.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Background check completion, including drug screening where required by site protocol, is a condition of employment. All qualified applicants are considered without regard to race, color, religion, sex, national origin, disability, age, veteran status, or any other characteristic protected under applicable federal, state, and local law. Reasonable accommodations for individuals with disabilities are available upon request throughout the application and employment process. Candidates must hold current authorization to work in the United States without employer sponsorship.

The Clinical Data Coordinator owns the accurate completion, filing, and archival of case report forms and source documents for clinical research studies, ensuring all subject data and study files meet FDA requirements and sponsor deadlines. Reporting to the Research Team Leader and working alongside the Project Manager, principal investigator, and sponsor representatives, this role delivers the audit-ready documentation that allows studies to withstand regulatory review long after completion.

Key Responsibilities

• Work with sponsor representatives at all meetings and visits when case report form data is reviewed.
• Ensure all subject data is boxed as required for study archiving.
• Develop filing system for each study to ensure each subject folder will be accessible to others if necessary.
• Ensure each folder is eventually complete and orderly with all required forms completed and audited for accuracy.
• Flag any discrepancies in data to be resolved by appropriate staff.
• Ensure proper documentation to the study file addressing any study issues so all aspects of the study are clear even years after study is completed.
• Review protocol and case report forms to determine study specific information.
• Evaluate for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria for case report form completion.
• Ensure accurate and timely completion of study CRFs to meet sponsor requirements and deadlines.
• Inform Research Team Leader and Project Manager of any issues or problems which may cause delays.
• Ensure principal investigator signs all CRFs and is apprised of any data issues on the study.
• Ensure all study participants' paperwork is complete and adequately reflects participation in the study as per FDA requirements.
• Box completed study information in accordance with the clinical archival process.
• Resolve any sponsor queries after the study has been completed.
• Ensure all case report forms and subject folders are reviewed by QA prior to review by sponsor or signature by PI.
• Set up sponsor rooms prior to sponsor visit.

Required Qualifications

• High school diploma or equivalent and relevant formal academic or vocational qualification required.
• Bachelor's degree preferred.
• Technical positions may require a certificate.
• At least 2 years of experience providing the knowledge, skills, and abilities to perform the job, or equivalent combination of education, training, and experience.
• Basic computer skills including knowledge of Microsoft Office and ability to learn various programs and systems such as Oracle database.
• Strong auditing and documenting skills.
• Demonstrated ability to manage multiple responsibilities and complete projects in a work or school setting.
• Strong attention to detail and strong planning and organization capabilities to manage multiple tasks and study groups at one time.
• Effective time-management skills.
• Strong communication skills with ability to clearly explain information to a wide variety of individuals.
• Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings.
• Ability and willingness to learn to administer investigational drugs or test investigational devices.

Embedded within the site research team, the Clinical Data Coordinator delivers accurate, timely data entry and query resolution in support of ongoing clinical research activities, ensuring all work is performed within site and regulatory expectations. Working closely with site staff and leadership, this role builds the reliable data foundation that enables studies to proceed on schedule and in compliance with applicable standards.

Core Functions

• Complete daily project-specific data entry, query resolution, and other data management responsibilities.
• Ensure accuracy and timeliness of data entry.
• Enter applicable information into the EDC system.
• Perform job functions within site and regulatory expectations.
• Contribute to and support research activities at the site.

Skills & Qualifications

• High school diploma or equivalent required.
• Knowledge of medical terminology.
• Proficient in routine office procedures and tools including MS Office and other web-based platforms.
• Demonstrable organization skills and detail orientation.
• Ability to manage multiple priorities.
• Ability to work independently and as part of a team.
• Excellent written and verbal communication skills.

Reporting to site leadership, the Clinical Data Coordinator leads data review, query generation, and database testing activities across clinical study sites, ensuring the integrity of study records from database release through final archival. Partnering with CRAs, third-party data sources, and internal study teams, this role shapes the quality controls that keep studies compliant with Clinical Standards and on track for sponsor and regulatory review.

Primary Duties

• Generate status reports and distribute to the study team and clinical study sites as appropriate.
• Follow up with study team members and study sites on outstanding items.
• Assist with CRA preparation for on-site monitoring activities.
• Assist with the development of CRFs and CRF Completion Guidelines to serve as an aid for site personnel.
• Perform user acceptance and database testing to ensure quality and integrity of the clinical study database prior to release.
• Conduct data review and associated query generation and resolution.
• Reconcile data from third-party sources with the clinical study database and communicate discrepancies to appropriate parties.
• Maintain accurate and complete study records including filing, archiving, inventory of study documents, and shipping.
• Perform routine audits of study files and security records to ensure compliance with Clinical Standards.
• Identify problems, issues, and delays and proactively escalate as appropriate to minimize project impact.

Experience & Qualifications

• High school diploma required; undergraduate degree preferred from an accredited program.
• At least 1 year of clinical research experience, or equivalent industry experience, certification, or training.
• Understanding of clinical research process and regulatory requirements.
• Experience with MS Word, Excel, and PowerPoint.
• Able to acquire and apply new technical skills.
• Highly organized with the ability to manage multiple activities concurrently.
• Establishes rapport and collaborates with internal and external team members to build constructive and effective relationships.
• Follows through on all tasks and ensures quality results.
• Effective verbal and written communication skills.

Sitting at the intersection of data quality and regulatory compliance, the Clinical Data Coordinator delivers accurate tracking, query resolution, and audit support across active clinical trials, ensuring participant confidentiality and data milestones are consistently maintained. Operating across departmental and sponsor-facing workflows, this role supports supervisors and managers with proactive issue communication and the training compliance documentation that keeps trial operations audit-ready.

Duties

• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Maintain and advocate a high level of quality and customer service within the department.
• Update and maintain tracking tools to ensure clinical trial data milestones are met.
• Review exported and manually entered data entries for completeness.
• Record, track, and ensure the resolution of data queries.
• Review data entry guidelines for potential errors and logic discrepancies and escalate findings.
• Complete clinical trial-specific database trainings when required.
• Assist in sponsor and regulatory audits as needed.
• Proactively communicate issues and problem resolutions to departmental supervisors and managers.
• Complete and maintain training as required per job needs.
• Perform general administrative tasks when required.

Education & Experience

• High school diploma or GED required; college degree and related work experience preferred.
• Prior medical, healthcare, or research experience preferred.
• Data entry experience preferred.
• Understanding of medical terminology.
• Proficient in Microsoft Office including Excel, PowerPoint, Word, and Publisher.
• Proficient in SharePoint.
• Ability to type 35–40 words per minute.