Clinical Data Coordinator
$2,800 - $4,000 per monthSomewhere
Clinical Data Coordinator
Location: 100% Remote
Employment Type: Independent Contractor Agreement
Working Hours: Must be available to work during U.S. Eastern Standard Time (EST) business hours
Compensation: USD $2,800 â $4,000/month , based on experience
About the Role
We are seeking an experienced and detail-oriented Clinical Data Coordinator to join our Clinical Data Management team. Reporting to the Clinical Data Manager and/or Head of Regulatory Affairs, you will play a key role in ensuring the integrity, accuracy, and completeness of clinical trial data throughout the study lifecycle. This position is ideal for a proactive professional with strong clinical data management expertise who thrives in a collaborative, fast-paced environment.
Key Responsibilities
- Manage clinical trial data using Electronic Data Capture (EDC) systems.
- Perform ongoing data review, validation, and discrepancy resolution in collaboration with clinical study teams.
- Execute query management activities to ensure high-quality, protocol-compliant data.
- Ensure all data management activities are conducted in accordance with Data Management Plans, Data Validation Plans, Edit Check Plans, company SOPs, GCP, and applicable regulatory requirements.
- Maintain study documentation, data query logs, and ensure proper archival of Clinical Data Management documentation within the Trial Master File (TMF).
- Collaborate closely with Clinical Operations, Quality Assurance, Regulatory Affairs, and other cross-functional teams to maintain data integrity throughout the clinical trial process.
- Perform data cleaning, discrepancy management, Serious Adverse Event (SAE) reconciliation, and vendor data integration activities to support timely database lock.
- Conduct periodic data quality reviews and contribute to continuous process improvements.
- Participate in cross-functional study meetings and support project timelines and deliverables.
Qualifications
Required
- Bachelor's degree in Life Sciences, Healthcare, Information Technology, or a related field.
- 4+ years of experience in Clinical Data Management or a related clinical research role.
- Hands-on experience with Electronic Data Capture (EDC) systems; experience with Crucial Data Solutions/TrialKit is highly preferred.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Advanced proficiency in Microsoft Excel and other clinical data management tools.
- Exceptional attention to detail, organizational skills, and analytical abilities.
- Strong written and verbal communication skills with the ability to collaborate across multidisciplinary teams.
Vacancy posted 9 days ago
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