Clinical Research Coordinator Team Lead - Ri Biobeh Skeens

Overview:

The Team Lead’s primary responsibility is train, develop and oversee Clinical Research Coordinators through oversight and guidance in all aspects of the studies being conducted. The Team Leader also is responsible for ensuring protection of human subjects’ rights through IRB regulations. In addition to supporting other CRCs, the Team Lead will have opportunities to manage their own clinical trial in accordance with the needs of the team’s portfolio. Further responsibilities will include leading study start-up and participation in compliance and quality assurance initiatives within the team.

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.

Responsibilities:

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Provide professional support to direct reports in all elements of Clinical Research operations to ensure proper training and support, compliance with all regulatory and process expectations and to provide regular review of performance.
• Assists with quality control/quality assurance; ensuring proper study start-up, auditing consents/assents, documentation, and study protocols (as required).
• Performs research activities as outlined in the protocol; conducts subject data collection and performs study protocol procedures according to recognized skill level and certifications; collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
• Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management; documents required observations on source documents as required by the protocol.
• Verifies that the subject meets inclusion/exclusion criteria; verified that the subject and/or legal guardian have provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
• Lead study start-up activities to ensure each study is started using best practices and utilizing team and institutional resources.
• Responsible for regulatory/IRB issues after a study has been initiated by the study sponsor.
• Serve as a liaison between study sponsors and study teams through effective communication, problem solving and critical thinking. 9. Performs other duties and maintains flexible schedule as required by a protocol or management/investigator needs; provides cross coverage for other team members as needed.

Qualifications:

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• Bachelor of Science degree preferred or 3-4 years of experience in managing clinical trials required.
• Certification as a Clinical Research professional required (SOCRA or CCRP).
• Understanding of FDA regulations is required.
• Highly experienced and knowledgeable in coordinating research activities and responsibilities.
• Lab Competency for the processing of research samples
• Advanced understanding of medical terminology required.
• Excellent verbal and written communication skills. ? Demonstrates analytic skills with accuracy and attention to detail.
• Organizes, analyzes and prioritizes workflow. ? Adapts easily to stressful and urgent situations with short deadlines.
• Possesses computer and software application skills (Windows 2000, Microsoft Access, Excel and Word).
• Capable of exercising sound judgment, self discipline and problem solving abilities.
• Demonstrates diplomacy, tact and a professional demeanor.
• Works collaboratively within the health care team.
• Functions as Team Leader to promote and maintain positive relationships.
• Identifies personal strengths and weaknesses and seeks appropriate resources as needed.
• Familiar with process improvement strategies preferred.
• Works independently with minimal supervision.

 

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 (0-33%)
• Typing on keyboard; frequently (34-100%)

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