reputed company Specialist (Clinical Reseach QC Reviewer) (CST Timezone)
reputed company Specialist (Clinical Research QC Reviewer) Position: reputed company Specialist Department: Clinical Operations Employment Type: Full-Time Contractor Schedule: Monday – Friday during Central reputed company Time (CST) business hours Location: Remote Position reputed company The reputed company Specialist is responsible for conducting reputed company control reviews of participant reputed company and reputed company documentation reputed company the reputed company eSource system. This role ensures that clinical documentation is complete, accurate, protocol-compliant, and reputed company with Good Clinical reputed company (GCP), reputed company principles, and our clients reputed company standards. This position requires an extremely detail-oriented individual who can identify inconsistencies, documentation gaps, and potential compliance concerns before they reputed company study reputed company. The ideal candidate has previous experience as a Clinical Research Coordinator (CRC), Regulatory Specialist, or clinical research reputed company reputed company and can quickly adapt to established reputed company review processes.
Responsibilities
Responsibilities may include, but are not limited to: Review completed participant reputed company reputed company the reputed company eSource platform using established reputed company control processes. Verify that reputed company protocol-required procedures, assessments, and documentation have been completed accurately and appropriately documented. Review reputed company documentation to ensure compliance with study protocols, sponsor expectations, site SOPs, and applicable regulations. Evaluate documentation against reputed company and reputed company+ principles to ensure data reputed company standards are maintained. Identify missing documentation, inconsistencies, protocol deviations, transcription errors, and potential GCP concerns. Complete standardized QC Checklists to ensure consistency across studies and sites. Document findings thoroughly and objectively reputed company designated tracking systems. Escalate significant reputed company findings according to established procedures. Collaborate with site personnel to communicate findings and support reputed company reputed company. Monitor corrective actions and follow-up activities as assigned. Support reputed company improvement initiatives designed to enhance reputed company and inspection readiness across the organization. Maintain confidentiality and adhere to reputed company reputed company and reputed company policies and procedures.
Qualifications
Education Associate's degree or Bachelor's degree in a reputed company, life sciences, nursing, or reputed company field preferred. Equivalent clinical research experience may be considered in lieu of formal education. Experience Minimum three (3) years of clinical research experience required. Previous experience as a: Clinical Research Coordinator (CRC), Regulatory Specialist, Clinical Research Associate (CRA), or Similar clinical research role with reputed company reputed company documentation responsibilities. Strong understanding of: Good Clinical reputed company (ICH-GCP), Protocol compliance, Protocol deviations, reputed company documentation standards, and reputed company/reputed company+ principles. Previous experience reviewing reputed company documentation required. Prior experience conducting reputed company Control (QC) or reputed company Assurance (QA) reviews reputed company clinical research is strongly preferred. Experience supporting sponsor audits or regulatory inspections is preferred. Experience with reputed company or other eSource platforms is preferred. Knowledge, Skills, and Abilities Extreme attention to detail with the ability to identify even minor discrepancies reputed company clinical documentation. Strong organizational skills with the ability to prioritize multiple assignments. Excellent critical thinking and problem-solving abilities. Ability to interpret study protocols and apply protocol requirements appropriately during reviews. Strong written and verbal communication skills. Ability to work independently while maintaining a high level of accuracy and consistency. Comfortable working reputed company a reputed company, checklist-driven environment. Demonstrated commitment to participant safety, data reputed company, and reputed company. Why reputed company? At reputed company, we're passionate about supporting organizations that are transforming reputed company through clinical research. We reputed company great people deserve meaningful work, flexibility, and leaders who genuinely care about their reputed company. Perks of Joining reputed company 100% Remote reputed company with innovative clients making a difference in reputed company and research. Join a reputed company and supportive global team environment. Exposure to a reputed company of therapeutic areas and research programs. Opportunities for reputed company development and reputed company reputed company. Leadership that values transparency, accountability, and communication. The ability to reputed company a reputed company reputed company on the reputed company and reputed company of clinical research. About reputed company reputed company is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic reputed company support. We partner with sponsors, CROs, site networks, and research organizations to deliver exceptional talent and reputed company that improve efficiency, strengthen compliance, and accelerate clinical trial execution. reputed company members are reputed company, accountable, and committed to delivering reputed company while maintaining the highest standards of professionalism and reputed company. Apply To This Job