Clinical Research Data Coordinator

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. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team player. This role reports directly to the Director of Compliance and Data Management.

Specifically, the Clinical Research Data Coordinator will be responsible for:

• Maintain subject and document confidentiality at all times, understand and comply with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, Good Clinical Practices, 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


• Responsible for CTMS (CRIO) and EDC data management which is essential for daily business operations


• Record information into various study-specific data-capture systems (both electronic and paper-based). Ensure that all adverse events, concomitant medications, and medical histories are transcribed accurately


• Perform daily query resolution with minimal errors


• Assist in the creation of data management process 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 details of clinical data to identify missing or inaccurate data; track data inconsistencies for 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, industry sponsor representatives, central laboratory and imaging personnel to resolve queries to ensure clinical data quality and compliance


• Coordinate multiple complex projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume


• Collaborate with study staff in the preparation of study audits, quality reviews, and monitor 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 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 previous 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, including keen attention to detail


• Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission


• Comply with the 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


• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner


• Must handle confidential matters and sensitive information with discretion and judgment


• Ability to manage small projects personally and work independently


• Ability to understand and interpret clinical research protocols and other applicable sponsor documents

 Other benefits include:

•  401k


• 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.