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Description
(Full-time, on site)
The Clinical Research Assistant: Focuses primarily on Data Entry and Patient Recruitment. The role supports clinical research studies by ensuring data quality, completeness, and compliance with study protocols and identifying and pre-screening potential participants according to study protocols and inclusion/exclusion criteria.
This position is ideal for an experienced patient recruiter or a person with great people skills who is comfortable and confident when speaking with potential trial participants over the phone. A detail-oriented individual who is interested in building a career in clinical research could be a great fit.
ObjectiveHealth is a clinical research company transforming how research is conducted at the point of care. Using our proprietary technology, we aim to:
- Increase patient access to research trials within our communities
- Provide physicians with enhanced care options for current patients
- Deliver superior clinical research enrollment metrics to Pharma sponsors
All with the ultimate goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.
Key Responsibilities:
Data Entry
- Enter clinical trial data into Electronic Data Capture (EDC) systems accurately and within required timelines.
- Review source documents and medical records to ensure complete and accurate transcription of participant data.
- Verify data for accuracy, completeness, and consistency prior to submission.
- Review, investigate, and resolve EDC data queries generated by sponsors, contract research organizations (CROs), or data management teams by comparing source documentation and collaborating with study personnel.
- Communicate with Clinical Research Coordinators, investigators, and other study staff to resolve missing, incomplete, or inconsistent data.
- Correct data discrepancies while maintaining appropriate documentation and audit trails within the EDC system.
- Ensure timely completion of data entry and query resolution to support study milestones and database lock.
- Adhere to study protocols, sponsor requirements, Good Clinical Practice (GCP), HIPAA, and applicable regulatory guidelines.
- Assist with quality control reviews and support sponsor monitoring visits, audits, and regulatory inspections as needed.
- Maintain confidentiality of participant information and research data.
Patient Recruitment
- Identify and pre-screen potential participants according to study protocols and inclusion/exclusion criteria.
- Review EMRs (including ObjectiveHealth and other systems) to identify eligible patients. Conduct chart reviews.
- Schedule and coordinate pre-screening and screening visits, maintaining organized and full site calendars.
- Collaborate with Clinical Research Coordinators, site teams, and leadership to align recruitment strategies and meet or exceed enrollment targets.
- Maintain knowledge of study protocols and regulatory requirements (HIPAA/GCP).
Requirements
- High school diploma or equivalent.
- 1+ years of data entry, administrative support, medical office, or related experience.
- Research experience or patient recruitment experience is a plus.
- Basic understanding of medical terminology
- Use of Electronic medical systems and other healthcare system experience
- Excellent attention to detail and data accuracy.
- Strong organizational and time management skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Strong written and verbal communication skills