What are the responsibilities and job description for the Clinical Research Quality Control Specialist position at SRA Trials?
Quality Control Specialist - Clinical Trials
Suncoast Research Associates is a privately owned and operated research organization established in 2018. We help volunteers get involved in clinical trials which allow patients to play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Our company works with all major pharmaceutical companies and conducts studies in a myriad of therapeutic areas. We are located in Doral, Florida and do not offer remote work.
Key Responsibilities
- Demonstrate exceptional attention to detail, organization, and accountability while managing multiple priorities in a fast-paced clinical research environment.
- Independently review and interpret study protocols, amendments, investigator brochures, and study manuals to ensure accurate application of study requirements.
- Perform quality control (QC) review of clinical data across multiple protocols and therapeutic areas, including concurrent enrolling studies.
- Conduct thorough review of medical records, source documents, and study charts in collaboration with Investigators and site staff to ensure data integrity and protocol compliance.
- Complete accurate and timely data review within electronic data capture (EDC) systems (e.g., Inform, Medidata Rave, Veeva Vault).
- Ensure adherence to sponsor and study timelines for data entry, query resolution, and database updates in accordance with SRA or sponsor expectations.
- Perform routine and targeted quality assurance checks to verify that study processes and data meet protocol, GCP, and regulatory standards.
- Identify, document, and escalate data discrepancies, deviations, and quality issues; support root cause analysis and corrective and preventive actions (CAPA).
- Analyze data trends and patterns to identify opportunities for process improvement and enhanced data quality.
- Collaborate cross-functionally with study coordinators, investigators, monitors, and sponsors to resolve data queries and quality concerns efficiently.
- Support and coordinate monitoring visits, audits, and inspections, ensuring all required documentation is accurate, complete, and audit-ready.
- Respond to and help resolve data queries generated by monitors, auditors, or other reviewers in a timely and effective manner.
- Maintain accurate and comprehensive documentation of QC activities, findings, and resolutions.
- Provide administrative and clerical support, including order entry and study-related documentation tasks as needed.
- Communicate professionally and effectively with internal teams, sponsors, CROs, and external vendors.
Required skills and abilities
- Strong organizational skills with the ability to prioritize tasks and meet deadlines.
- Proficient in data collection, analysis, and reporting using tools such as Excel and pivot tables.
- Attention to detail and a high level of accuracy in transcribing information.
- Basic math skills for performing calculations related to quality assurance.
- Excellent communication skills, both written and verbal.
- Proficient in Microsoft Office suite (Word, Excel, PowerPoint).
- Previous experience in quality assurance or related role is preferred.
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- Onsite (no remote work)