Clinical Research Data Coordinator
Pinnacle Clinical Research, Edinburg, TX, United States
Overview
Summary:
The Clinical Research Data Coordinator (CRDC) will abstract clinical data and research data from electronic medical records and other sources and enter this data into an electronic data capture system utilized for the clinical research protocol. The CRDC will be responsible for entering quality data for multiple clinical trials and conducting data activities in an efficient manner and in accordance with regulations. This role reports directly to the Director of Compliance and Data Management.
Responsibilities
Maintain subject and document confidentiality at all times, understanding and complying with sponsor requirements and regulations such as the Food and Drug Administration, Good Clinical Practice, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.
Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Verify all records are readable, accurate, and complete.
Manage CTMS (CRIO) and EDC data management essential for daily business operations.
Record information into various study‑specific data‑capture systems (both electronic and paper‑based). Ensure all adverse events, concomitant medications, and medical histories are transcribed accurately.
Perform daily query resolution with minimal errors.
Assist in creating data management processes for quality control and assurance.
Perform auditing and review of CTMS and EDC entries to ensure compliance standards are maintained.
Assist in preparing for regulatory agency inspections and sponsor audits.
Maintain awareness of clinical data details to identify missing or inaccurate data; track inconsistencies for the Clinical Research Operations team to review and report accordingly.
Act as primary contact with sponsor’s data management team to resolve and review any data management issues.
Exercise independent judgment on query resolutions.
Create reports to track data and quality metrics.
Collaborate with internal site staff and external personnel such as physicians, nurses, administration, sponsor representatives, central laboratory and imaging personnel to resolve queries and ensure data quality and compliance.
Coordinate multiple complex projects with competing priorities and deadlines as needed based on protocol directives and study volume.
Collaborate with study staff in the preparation of study audits, quality reviews, and monitoring visits.
Provide cross‑coverage support on study and site activities as assigned.
Create source document development per data capture requirements per protocol.
Assist with the implementation of quality assurance data management plans and other auditing processes as needed.
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Qualifications
Bachelor’s Degree in a scientific area of study or equivalent combination of education, training, and experience.
Previous experience in a clinical research environment or equivalent work environment.
1–2 years of data entry experience as a clinical research coordinator, clinical research assistant, or data entry specialist for therapeutic clinical trials.
Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) required.
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
Familiarity with clinical trial management system software, preferably Clinical Research IO.
Basic medical knowledge, including medical terminology.
Demonstrated competence in oral and written communication.
Must complete CITI and GCP training certification.
Demonstrated organizational skills and outstanding time management, with keen attention to detail.
Possess impeccable integrity and personal and professional values consistent with PCR’s high standards and mission.
Comply with company policies, code of ethics, and guiding values at all times.
Competencies
Strong analytical and problem‑solving skills.
Detail oriented with the ability to perform at a high level of accuracy.
Proactive at identifying and addressing issues in real time.
Flexible with changing priorities and able to communicate diplomatically and professionally.
Handle confidential matters and sensitive information with discretion and judgment.
Ability to manage small projects personally and work independently.
Understand and interpret clinical research protocols and other applicable sponsor documents.
Benefits
401(k)
Medical, dental, vision and more
3 weeks of paid time off
13 paid company holidays
Scrub voucher (specific positions apply)
And more!
Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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Summary:
The Clinical Research Data Coordinator (CRDC) will abstract clinical data and research data from electronic medical records and other sources and enter this data into an electronic data capture system utilized for the clinical research protocol. The CRDC will be responsible for entering quality data for multiple clinical trials and conducting data activities in an efficient manner and in accordance with regulations. This role reports directly to the Director of Compliance and Data Management.
Responsibilities
Maintain subject and document confidentiality at all times, understanding and complying with sponsor requirements and regulations such as the Food and Drug Administration, Good Clinical Practice, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.
Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Verify all records are readable, accurate, and complete.
Manage CTMS (CRIO) and EDC data management essential for daily business operations.
Record information into various study‑specific data‑capture systems (both electronic and paper‑based). Ensure all adverse events, concomitant medications, and medical histories are transcribed accurately.
Perform daily query resolution with minimal errors.
Assist in creating data management processes for quality control and assurance.
Perform auditing and review of CTMS and EDC entries to ensure compliance standards are maintained.
Assist in preparing for regulatory agency inspections and sponsor audits.
Maintain awareness of clinical data details to identify missing or inaccurate data; track inconsistencies for the Clinical Research Operations team to review and report accordingly.
Act as primary contact with sponsor’s data management team to resolve and review any data management issues.
Exercise independent judgment on query resolutions.
Create reports to track data and quality metrics.
Collaborate with internal site staff and external personnel such as physicians, nurses, administration, sponsor representatives, central laboratory and imaging personnel to resolve queries and ensure data quality and compliance.
Coordinate multiple complex projects with competing priorities and deadlines as needed based on protocol directives and study volume.
Collaborate with study staff in the preparation of study audits, quality reviews, and monitoring visits.
Provide cross‑coverage support on study and site activities as assigned.
Create source document development per data capture requirements per protocol.
Assist with the implementation of quality assurance data management plans and other auditing processes as needed.
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Qualifications
Bachelor’s Degree in a scientific area of study or equivalent combination of education, training, and experience.
Previous experience in a clinical research environment or equivalent work environment.
1–2 years of data entry experience as a clinical research coordinator, clinical research assistant, or data entry specialist for therapeutic clinical trials.
Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) required.
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
Familiarity with clinical trial management system software, preferably Clinical Research IO.
Basic medical knowledge, including medical terminology.
Demonstrated competence in oral and written communication.
Must complete CITI and GCP training certification.
Demonstrated organizational skills and outstanding time management, with keen attention to detail.
Possess impeccable integrity and personal and professional values consistent with PCR’s high standards and mission.
Comply with company policies, code of ethics, and guiding values at all times.
Competencies
Strong analytical and problem‑solving skills.
Detail oriented with the ability to perform at a high level of accuracy.
Proactive at identifying and addressing issues in real time.
Flexible with changing priorities and able to communicate diplomatically and professionally.
Handle confidential matters and sensitive information with discretion and judgment.
Ability to manage small projects personally and work independently.
Understand and interpret clinical research protocols and other applicable sponsor documents.
Benefits
401(k)
Medical, dental, vision and more
3 weeks of paid time off
13 paid company holidays
Scrub voucher (specific positions apply)
And more!
Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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