The Behavioral Trials Office is looking for a Clinical Research Coordinator II to support our mission of providing efficient coordination of diverse behaviorally-focused clinical research, including behavioral intervention trials and observational research. Our work spans a variety of pediatric departments and developmental stages. The Clinical Research Coordinator II is responsible for managing all of the 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, data coding, analysis, report generation, and study closure activities. The CRC II also trains and mentors other clinical research staff to ensure consistency in study management and coordination activities.

When submitting application please include your Cover Letter and CV. Thank you

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Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.

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Essential Job Functions:

• Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure participant safety throughout study; adheres to good clinical practices.
• Interact with research participants, Principal Investigators, and hospital departments in-person, virtually, and over the phone.
• Recruits, consents and enrolls participants according to ICH/GCP regulations, and participant’s rights through institutional IRB, federal and state regulations; ensures the participant meets inclusion/exclusion criteria; answers questions related to the protocol procedures as applicable; acts as a patient/family advocate.
• Coordinates and schedules participant study visits with study partners (e.g., other hospital services, the PI/sub-I, community partners, parallel studies).
• Collects and manages protocol required data such as standardized and semi-structured assessments, observational or technology assisted data (e.g., Actigraphy), biological specimens, and archival data; scores data according to established procedures.
• Performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens and/or data for use in research studies per the IRB approved protocol.
• Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success.
• Assists with the study recruitment plan and manages participant incentive disbursement via established procedures; manages all screening, enrollment and study participation logs; provides recruitment summaries throughout the study.
• Creates source documents and/or databases that facilitate systematic data collection and/or aid in protocol execution, management. and record keeping; and conducts accurate and timely participant data collection.
• Assists with study database development to maintain study data in de-identified format, according to recognized skill level; accurately completes data collection forms.
• Trains, mentors, and educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
• Alerts the investigator or manager when the participant’s safety is in jeopardy, there is a protocol deviation, or when the participant requests premature study termination.
• Responsible for maintenance of IRB records and essential documents.
• Completes data coding/scoring and statistical analyses as directed by the Principal Investigator. Creates visual representations of analyzed data and collaborates on dissemination of research results. Note: Regular, reliable and consistent attendance is an essential job function. Employees are expected to perform work as scheduled. Please see the physical requirements for this position listed below.

Knowledge, Skills & Abilities:

Education Requirement:

• BA/BS preferred; Associates degree or equivalent work-related experience required. Certifications: CRA/CRC certification preferred.

Skills:

• Experience and interest in working with diverse populations.

• Understanding of medical terminology and clinical trials preferred.

• Working knowledge of PCs and word processing and data management software.

• Demonstrated analytical skills with accuracy and attention to detail.

• Goal-oriented and self-directive, ability to manage multiple complex projects independently.

• Demonstrated independence and responsibility, including effective problem solving, and demonstrated ability to effectively balance multiple priorities.

• Excellent verbal and written communication skills.

• Strong organizational and interpersonal, including the ability to engage participants effectively over the telephone and in person.

• Ability to actively participate as a team player and to work collaboratively with research participants, supervisors, and coworkers.

Experience:

• Minimum of 18 months experience in clinical research or health care field, two years preferred.

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. EOE M/F/Disability/Vet