Clinical Research Coordinator II - RI Biobeh Skeens

The Skeens Lab is seeking a Clinical Research Coordinator II to provide long-term support to our team's growing body of research projects. Our lab is devoted to investigating the psychosocial and biobehavioral outcomes of children facing cancer and undergoing hematopoietic stem cell transplants. Our mission extends beyond research; we strive to develop innovative digital health interventions, with a specific focus on underrepresented and vulnerable populations. We are committed to addressing the unique needs of diverse communities, including those who speak different languages and reside in rural and Appalachian areas. A full list of our research projects can be found at the Skeens Lab Website.

The Clinical Research Coordinator's 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. The CRC II also trains and mentors other CRCs to ensure consistency in study management activities.

Important Note: In addition to submitting an application on the NCH careers site, interested applicants must email a cover letter to Kerry.Orton@NationwideChildrens.org.

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.

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:

Screens and recruits families for research studies in clinical settings. Maintaining follow-up contact by phone and email with study participants.
• Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
• Collects and enters research data and subject information in an electronic database (REDCap, Smartsheet).
• Assists Project Manager in maintenance of lab project management software (Smartsheet)
• Maintains professional communication with support services (Information Services, etc.) to facilitate positive cross-team relationships and efficient utilization of resources.
• 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,
• Responds to patient inquiries regarding specific study criteria and questions about recruitment. Collaborates effectively with other team members when needed on this task.
• Assists Project Manager in training and education of other study personnel with regards to study responsibilities; creates and maintains manuals of procedures (MOPs) and other training documents.
• Responsible for regulatory/IRB preparation including maintaining study regulatory binders and preparing initial IRB submissions, amendments, continuing review, and adverse events or deviations.
• 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

Reports to: Project Manager and Principal Investigator

• Minimum BA/BS required
• Preferred 1 year experience in clinical research or health care field.
• Skills required:
  1. Strong knowledge of PCs and data management software
  2. Excellent verbal and written communication skills
  3. Goal-oriented; self-directed
  4. Initiation, motivation, creativity, flexibility
  5. Organizational skills and excellent interpersonal relationship building
  6. Ability to actively participate as a team player
  7. Mentoring/training of new team members

1. Fluency in Spanish is desired, but not required.

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.