Full Time, Benefit Eligible
Clinical Research Coordinator: Primary responsibility is managing elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
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Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:
• Schedules subject study visits with families and other hospital services (e.g. CRS, MRI, EEG, Speech Pathology, investigators) and ensures effective communication with all parties.
• Collects and enters research data and subject information in an electronic database as well as a paper file containing all source documentation. Collects all investigator training, CVs, and licenses for the Regulatory binder. Ensures that all items such as this that need completed per protocol are completed accurately by all study personnel.
• Collects and prepares human specimens (urine, stool, saliva per protocol) for use in laboratory studies. Such activities may be performed independently and may require evening and weekend hours.
• Creates case report forms/source documents to facilitate systematic data collection and/or aid in protocol execution and management as well as record keeping; conducts accurate and timely subject data collection,
• Responsible for working with Research IT to set up the electronic database (e.g. Open Clinica) based on data collection requirements when needed.
• Assists in the recruitment plan and implementation and in cost estimation during feasibility/eTrac entry; manages screening and recruitment logs, and completes recruitment summary at study termination.
• Secures accommodations and travel arrangements for subjects traveling from out of town (lodging, reimbursement if applicable and submitting check requests)
• Responds to patient inquiries regarding specific study criteria and questions about recruitment. Collaborates effectively with other team members when needed on this task.
• Takes photographs of gene transfer procedure and follow-up visits and documents appropriately per study protocol.
• Cleans Clinical Research Services/ exam room following each study visit
• Drop off and pick-up of prescriptions to pharmacy as needed.
• Assists PI in education of other study personnel with regards to study responsibilities and keeps written documentation of this training and training with updated protocol changes and keeps record of updated Delegation of Authority log ensuring that they are complete with all personnel on the study
• Alerts the investigator when a subject’s safety is in jeopardy and when there is potential for a protocol deviation or when one has happened already if unable to anticipate an issue.
• Completes Case Report Forms (CRFs) as required completely
• Ensures CRF’s are completed prior to monitoring visits and works with monitor and the study team to resolve queries in the database as well as outstanding regulatory issues. Works with monitor during interim monitoring visits.
• Prepares preliminary Data Safety Monitoring Board (DSMB) report data (subject summary, AEs, deviations), gathers information from laboratory personnel and schedules and facilitates DSMB meeting
• Responsible for regulatory/IRB preparation including initial submissions, amendments, continuing review, and adverse events or deviations
• Creates Manual of Operating Procedures (MOOP) when needed.
• Accountable for cross coverage for other team members when they are out of the office and have patients scheduled
• Prepare weekly updates for Gene Therapy update meeting and present study status
• Prints, files, and maintains all CRFs and source documentation in appropriate binder-Regulatory, DSMB, MOOP, and Subject binders
• Assists the principal investigator in the preparation of scientific publications and grant proposals.
• Performs other duties and maintains flexible schedule as required by a protocol or management/investigator needs.
• Obtains vital signs including blood pressure, height, weight, when needed for the study
• Assist with holding or distraction of subjects during procedures/exam visits if needed
• Accompany patients to visits and delivery specimens and paperwork throughout the hospital
• Coordinate, set up, and facilitate for group subject visits or meetings as needed.
• Keep personal calendar efficiently up to date and meet deadlines that are needed for study and team participation
• Follow SOPs of the research team
KNOWLEDGE , SKILLS AND ABILITIES REQUIRED
1. Minimum BA/BS required
2. Preferred 1 year experience in clinical research or health care field.
3. Understanding of medical terminology and clinical trials preferred.
4. CRA/CRC certification obtained within two years of hire date
5. Skills required:
• Strong knowledge of PCs and data management software
• Excellent verbal and written communication skills
• Goal-oriented; self-directed
• Initiation, motivation, creativity, flexibility
• Organizational skills and excellent interpersonal relationship building
• Ability to actively participate as a team player
• Mentoring/training of new team members
MINIMUM PHYSICAL REQUIREMENTS Talking on phone/in person; frequently (34-100%) Sitting; frequently (34-100%) Standing/Walking; frequently (34-100%) Lifts objects weighing up to 25 pounds; occasionally (20-40% Typing on keyboard; occasionally (40-60%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.