Clinical Research Coordinator I - RI Behav Trials Off

Clinical Research Coordinator

The Behavioral Trials Office (BTO) works with investigators and research teams throughout the Abigail Wexner Research Institute and Nationwide Children's Hospital to support efficient coordination of diverse behaviorally-focused clinical research, including behavioral intervention trials (e.g., lifestyle, medication adherence, family communication, biofeedback, safe driving technology). Our work spans a variety of pediatric departments (e.g., psychology, developmental and behavioral pediatrics, clinical therapies) and developmental stages (e.g., infancy, adolescence).

We are seeking a Clinical Research Coordinator (CRC) to join our fast-paced and mission-focused team. The CRC performs research activities such as study start-up, day to day management, and study closure activities. The position requires an understanding of IRB, federal regulations, study protocols, and other regulatory processes and systems, as well as an understanding of the day to day clinical study process.

Why Nationwide Children's Hospital?

The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose.

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.

We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.

Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.

Nationwide Children's Hospital. A Place to Be Proud.

Principal Duties and Responsibilities

The CRC will coordinate with hospital services, the PI, and the study team and play an integral role in the regulatory/compliance processes and/or implementation activities of behaviorally focused clinical research.

• Regulatory activities may include protocol development, human subjects research submissions to the IRB, preparation of reports, creation of source documents to facilitate systematic data collection and record keeping, creating and maintaining study regulatory binders, standard operating procedure (SOP) development, and assistance with quality improvement initiatives.
• Implementation activities may include performing research activities as outlined in the protocol, such as participant screening, recruitment, consent, in-person and virtual data collection (e.g., interviews, online surveys, standardized assessments), and intervention implementation.
• 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.
• Recruits, consents, and enrolls participants according to ICH/GCP regulations, and participants' rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
• Completes screening sheets and recruitment logs.
• Ensures that the participant meets inclusion/exclusion criteria; alerts the investigator when the participant's safety is in jeopardy, there is a protocol deviation, or when the participant requests premature study termination.
• Collaborates, coordinates, and schedules participant study visits with study partners (e.g., other hospital services, the PI/sub-I, community partners, parallel studies); completes participant incentive payments.
• Collects and manages research data and participant information per the IRB approved protocol; and maintains accurate data collection of all study data. Data collected may include archival data, standardized and semi-structured assessments, observational or technology assisted data (e.g. Actigraphy), human biological specimens, and/or laboratory analytical procedures. Such activities may be performed independently and may require evening and weekend hours.
• Creates source documents and/or databases that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely participant data collection.
• Adheres to departmental quality control guidelines.
• Maintains regulatory binder and documents. Maintains recruitment/data collection records and essential documents, including assistance with IRB submissions and modifications.

Qualifications

Education:

Associates degree or equivalent work-related experience required. BA/BS preferred.

Certifications: Ability to obtain CRA/CRC certification in a timely manner.

Skills:

• Understanding of medical terminology and clinical research preferred.
• Working knowledge of PCs and word processing and data management software.
• Demonstrated analytical skills with accuracy and attention to detail.
• Excellent verbal and written communication skills.
• Goal-oriented and self-directive
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Minimum Physical Requirements

Occasionally 1-33% of time (0.5 to 2.5 hours) Squat/kneel, Reaching above shoulder, Driving, Exposed to fumes/gases/vapors, Exposed to loud noises, Exposed to cold temperatures Frequently 34-66% of time (2.6 to 5.0 hours) Bend/twist, Standing, Walking, Sitting, Lifting/carrying up to 50 lbs. may need assistance, Pushing/pulling up to 100 lbs. may need assistance, Exposed to blood and/or bodily fluids, Exposed to communicable diseases and/or pathogens, Exposed to chemicals/medications, Work with patient equipment, Exposed to biohazard waste, Work with machinery Continuously 67-100% of time (5.1 to 12 hours or greater) Flexing/extending of neck Hand use: grasping, gripping, turning, Repetitive hand/arm use, Computer skills, Audible speech, Hearing acuity, Depth perception, Peripheral vision, Seeing-far/near, Problem solving, Decision making, Interpreting data

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