Supports, facilitates, and coordinates daily activities for observational clinical research studies. Reports to a leader in the Clinical Research Operations team and works closely with investigators, sponsor representatives, and other Research Institute staff. Also works with Patient Access, Central Scheduling, HIM, and IT to ensure timely and accurate scheduling of research visits and compliant notation of these visits in the medical record. Assists principal investigators in ensuring that clinical research and related activities are performed in accordance with all applicable regulations, health system policies, and sponsor requirements.
Job Specific Duties
Maintains familiarity with assigned clinical research protocols, including studies' purpose, design, eligibility criteria, schedule of events, procedures, risks, and reporting requirements.
Collaborates with study investigators to screen and recruit patients to available clinical trials.
Prepares for & assists investigators with study subject visits, including ensuring that all visit assessments are scheduled/completed & all necessary study data are gathered/recorded appropriately.
Reviews source documents and case report forms for adverse events. Reviews case report forms entries for accuracy and completeness.
Enters and updates subject study statuses in the NCHRI CTMS within 72 hours. Enters all study visits, as required in the NCHRI CTMS with 72 hours.
Assists investigators in obtaining informed consent & assent from study participants and/or their parents and guardians, including ensuring all necessary signatures and dates are obtained.
Ensures language preferences are addressed and documented and all subject or guardian questions are addressed.
Coordinates the procurement and handling of study required biospecimens including, collection, processing, packaging, and shipment.
Coordinates payments and reimbursements to study participants and works with NCHRI finance staff to ensure timely payment.
Reports all unanticipated issues, adverse events, protocol deviations & subject complaints to appropriate parties as required by regulations, IRB requirements, sponsor guidelines & NCHS policies.
Schedules, prepare for & works with sponsor representative during & after monitoring visits. Enters corrections to case report forms, timely resolves queries & ensures study documents are correct.
Reviews protocol (and other applicable study documents) and provides study feasibility input to the NCHRI leaders.
Reviews and compares protocol, consent and study budget to ensure accurate inclusion of all required study assessments and procedures.
Assists investigators with completing study start-up documentation, including documents required for institution approval, IRB approval, and sponsor requirements.
Produces quality documentation, including completion of assessments within the specified time that is consistent with policies and standards. Coordinates the development of forms/questionnaires.
Assists investigators with completing required reports for IRB continuing review and approval.
Collaborates with Quality Assurance to ensure quality standards are being met.
Ensures compliance of study activities with federal regulations, protocol requirements and NCHS policies.
Attends and participates in team huddles and meetings, including being prepared to present updates on study statuses and subject enrollment statuses.
Attends and participates in investigator meetings, pre-study visits, and study/site initiation meetings.
Serves as a liaison with Patient Access and Central Scheduling for issues related to research subjects.
Coordinates with CRC’s to schedule research patient testing and procedures, including processing research encounter forms and creating research-specific Financial Identification Numbers (FINs).
Maintains records of all research encounters & research-related FINs and coordinates with study team and NCRI Finance.
Minimum Job Requirements
AA/medical/technical school (or) 2 years of research or healthcare experience required
IATA Dangerous Goods Regs within 6 months of hire date
Prior experience with electronic medical record and/or clinical trial management software applications
Knowledge, Skills, and Abilities
Bachelor's Degree in Science preferred.
Knowledge of the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP)
Current CITI certification in Human Subjects Research and Good Clinical Practice, highly preferred.
Experience with clinical trials management systems and clinical research electronic data capture systems, highly preferred.
Proficiency in Microsoft Office, including Outlook, Word and Excel, highly preferred.
Experience in pediatric hospital setting, preferred.
Bilingual in English/Spanish, preferred.
Good communication skills.
Good organizational skills, including the ability to multi-task.
