Clinical Research Coordinator II

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Job Summary

Clinical Research Coordinator II will oversee multiple clinical trials, serving as a point person for patients, their family members and the clinical study team. The position consists of working with various departments across the hospital, including forging new partnerships with departments to ensure completion of trial-related activities. The clinical research coordinator II will direct participants and study team members to adhere to the study protocol and rules and regulations as governed by regulatory bodies including Institutional Review Boards and the FDA.

Under general guidance duties include:
- oversee daily operations of clinical trials, recruitment, and clinical assessments of study subjects
- directing strict adherence to study protocols, as well as sponsor, FDA and other regulatory authority requirements.
- develop workflows for clinical trial, including reminders/updates to the clinical team
- delegate team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflow for patient care such as assigning secretaries to schedule patients, developing work flow with ancillary departments (such as radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members such as doctors to complete clinical tasks such as reviewing adverse events versus assigning non-clinical team members to complete non clinical tasks such as administering questionnaires to a patient.
- assist with training of new members of the team via multiple training routes such as didactic and shadowing
- oversee the work of less experienced clinical research staff
- execute IRB submissions, finance/budget review and participant compensation

The Clinical Research Coordinator II is expected to leverage exceptional working knowledge of good clinical practice (GCP) and ICH regulatory instructions for their trials.
The Clinical Research Coordinator II is expected to be able to manage a higher number of clinical trial projects.
The Clinical Research Coordinator II is expected to be able to manage more complex clinical trials, such as early feasibility trials.

Essential Functions

• Assist with the planning and project set up of new trials and study and financial closeout of existing trials.
• Assist with Quality Assessment across trials
• Escalates issues related to clinical trial conduct to PI and senior research staff.
• Assigns training to the PI and other research team members for protocol amendments, and any other study required training.
• Screens and consents patients and ensures the scheduling and completion of assessments for ongoing study visits as dictated by the protocol.
• Collects required data and imaging and ensures data entry into EDCs/Databases and image upload to imaging portals.
• Mentors, trains, and educates less experienced research coordinators and Research technicians regarding trial conduct.
• Investigates opportunities for Subject recruitment, screening and enrollment
• Oversees data collection, storage, and data entry of less experienced research coordinators and Research technicians for clinical research studies.
• Oversees the quality of data provided to sponsor, escalates quality issues to the site manager and assists in identifying opportunities to improve training, execution, and quality control across the clinical team.
• Maintains accurate records of study participants while safeguarding the confidentiality of subjects, as necessary.
• Maintains essential documents per FDA, Regulatory bodies, and sponsor requirements in the Regulatory Binder. This includes preparation and review of essential documents for the assigned clinical study
• Provides ready access to patient binders and regulatory binders to the PI, Sponsor and/or Regulatory Authorities for assigned clinical trials.
• Prepares and carries out monitoring visits and audits for assigned clinical trial; and assists and supervises site monitoring visit preparation by CRC I and other junior research staff.
• Collaborates with appropriate institutional review board to ensure approval of the clinical trial (initial and renewal), approval of study documents (renewal, modification, notification) and personnel.
• Assists management with collection of updated essential documents and certifications for site personnel and sends these to sponsor as requested.
• Participates in Site Initiation Visit. Assists with feasibility questionnaire and site qualification visits
• Processes, packages, stores and ships clinical specimens as required by the protocol.
• Responsible for device accountability, ordering and storage of investigational products and/or lab kits.
• Performs other duties as assigned dependent on the nature of the clinical trial.

Qualifications

• BS Required
• Experience in Clinical Trial Management Required
• 1-3 years 2 years experience Required
• CITI Good Clinical Practice Certification
• CITI Research with Biomedical Drugs and Devices Certification
• CITI Dangerous Goods and Biospecimen Handling Certification