Clinical Research Program Coordinator Non RN- CRO

Overview

The CONNECT Site Coordinator's primary responsibility is the overall administrative coordination and management of open clinical trials in the research portfolio for the COllaborative Network for NEurooncology Clinical Trials (CONNECT). CONNECT is a 24 site international collaborative whose mission is to expand access and develop novel, scientifically rational therapies for children with high-risk brain tumors. As primary study contact, the scope of this role spans from study startup activities, site trainings and activation, subject enrollments, tracking study data, communications with all sites, working with protocol writers to facilitate amendments and updates to study manuals, working with the IRB and general study team.

The Site Coordinator is a crucial role in our CONNECT Operations team which supports the entire collaborative of sites.

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

• Prepares and organizes all study start up and site start up documents.

• Prepares informed consent forms, participant handouts, study diaries as needed. Ensures participating sites (US and international sites) have all required documents.

• Conducts the trial coordination and regulatory requirements training for the Site Initiation Visits; facilitates site activation process.

• Facilitates trial enrollments, tracks potential enrollments and projections communicating with study team.

• Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple

• Coordinates and tracks other aspects of study operations as required.

• Schedules and prepares for study team meetings with study chairs and external parties.

• Corresponds with study chairs on study matters.

• Plays a central role in the communication between internal and external partners as necessary to keep studies on track.

• Assists with site emails in the central CONNECT email inbox.

• Attend calls with international collaborators as needed (some may be outside of 8-5 standard office hours).

• Ensures that regulatory documents are filed accurately in the Total Master File (TMF).

Qualifications

Education:

Bachelor's degree preferred or Associates degree with two years clinical research experience or project management experience.

ACRP or SOCRA certification preferred but not required.

Skills:

Two years clinical research experience or project management experience.

• Demonstrated leadership skills

• Strong organizational skills

• Exceptional interpersonal, written and verbal communication

• Ability to filter information, discern importance and initiate plan for project completion

• Self-directed, results driven with the ability to manage

• Ability to work independently and as part of a

• Strong proficiency in Microsoft Office

Minimum Physical Requirements:

• Talking on phone/in person; frequently

• Sitting frequently

• Standing/Walking; frequently

• Lifts objects weighing up to 25 pounds; occasionally

• Typing on keyboard; occasionally

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