Clinical Research Coordinator CDH Pediatric Outpatient Part-time Days
1 day ago
We are seeking a highly motivated and organized Clinical Research Coordinator to join our team at Northwestern Memorial Healthcare. The successful candidate will be responsible for coordinating and facilitating clinical research trials in a pediatric outpatient setting.
Key Responsibilities:- Coordinate and maintain logistical aspects of assigned study protocols, ensuring compliance with Good Clinical Practice, standard operating procedures, and sponsor requirements.
- Provide direct patient care, including dispensation of investigational medications and performance of study tests, under the delegation and direction of the principal investigator or supervising physician.
- Attend investigator's meetings, coordinate and attend pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
- Arrange for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study.
- Schedule and lead in-house protocol meetings to review study-related procedures, staffing, and visit flow.
- Schedule and coordinate all medical needs and coverage for protocol-related procedures.
- Maintain and document all study-related communication, including the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s), and IRB throughout the clinical trial.
- Responsible for giving subject instructions for study participation and serving as the primary contact for subjects, handling study-specific questions, concerns, or events.
- Ensure all protocol procedures are completed per study requirements.
- Obtain and document all adverse event data on appropriate forms and report adverse event data to the appropriate parties as outlined by the study protocol, regulations, and applicable policies and procedures.
- Assure quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval.
- Ensure accurate, complete, and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval.
- Schedule, lead, and assist with all study-related visits on site and be readily available during visits for applicable corrections, questions, or other study-related or site needs.
- Supervise document retention, security, and destruction, where applicable.
- Responsible for completing all necessary training for the position, including study protocol-specific training and Health System policies and procedures.
- Train other study-specific research staff in collection and reporting of required data, where applicable.
- Maintain research files, design forms as needed, report findings as appropriate, assist in preparation or review of material for submission to an IRB, including reviewing and editing protocols and consent documents, where applicable.
- Perform all other functions as related to this job and assigned.
- Ability to travel between hospital locations where research is conducted.
- Bachelor's degree in a related field.
- Two years of experience in managing all aspects of clinical research trials with in-depth knowledge of protocol requirements and Good Clinical Practice.
- Intermediate computer and internet knowledge.
- Excellent customer service and patient care skills.
- Meticulous organizational skills.
- Excellent demonstrated written and verbal communication abilities.
- Three to five years of experience in clinical research trials.
- ACRP or SOCRA certification.
We are committed to diversity and inclusion in the workplace. We do not discriminate on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation, or any other protected status.
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