Full-time, 40 Hours/Week

Monday to Friday, 8am - 4:30pm

Remote (Onsite as needed)

Summary:

Provides regulatory support to investigators conducting clinical research. Coordinates with study teams to ensure appropriate oversight and compliance with all Federal, State and Local regulatory requirements for mandated regulatory documents utilized in clinical research conducted by the RDCRI.

Responsibilities:
1.Protocol processing

2.Preparation of informed consent documents to comply with local policies

3.Preparation for IRB submission

4.Prepare and submit sponsor's essential regulatory documents

5.Process IRB submission and approvals

6.Preparation and maintenance of Regulatory Binders

7.Strategic review of the regulatory binders prior to monitoring visits

8.Other duties as required.

Other information:

Technical Expertise

1. Experience interacting with study monitors and FDA reviewers.

2. Knowledge of GCPs, SOPs, and regulatory documents required for clinical trials.

3. Demonstrates organizational and time management/prioritization skills.

4. Proficiency in MS Office [Outlook, Excel, Word] or similar software is required.

5. Proficiency in the English language with excellent use of grammar and spelling is essential.

6. Demonstrates effective communication skills for relating to and networking with all levels of personnel.

7. Demonstrates organizational and time management/prioritization skills.

8. Knowledge of medical terminology and diseases.

Education and Experience

1. Education: High school diploma and a minimum of four (4) years experience OR Associates Degree and minimum two (2) years experience OR Bachelor's Degree and minimum one (1) year experience working in a direct or related clinical trial setting.

2. Licensure: None

3. Certification: None

4. Years of relevant experience: One or more

5. Years of supervisory experience: None

Full Time

FTE: 1.000000

About Akron Children's

More Than a Job. It’s loving what you do - and why you do it. Akron Children’s Hospital is ranked among the best pediatric hospitals by U.S. News & World Report, but it’s our compassionate approach to treatment that sets us apart. It’s creating special high-fives. Thinking of new ways to spark a smile. Holding hands to offer comfort. And working to get a giggle that brightens a room. The minute you walk into Akron Children’s, you can sense that people here love what they do. From visits with the Doggie Brigade, to the balloons and smiles in the halls, the sights and sounds are all about one thing: the children. We are the largest pediatric healthcare system in Northern Ohio and one of the fastest growing in the country. Akron Children’s has two hospital campuses in Northeast Ohio: one in Akron and the other in Boardman in the Mahoning Valley. With two hospital campuses, regional health centers and more than 50 primary and specialty care locations throughout Ohio, we’re making it easier for today’s busy families - regardless of where they live - to find the high-quality care they need. No matter which of our locations you choose, you’ll see that when you give the most, you get more—...support, rewards and satisfaction. CAREER OPPORTUNITIES: It’s making the most of your days. Our passion is felt every day in the way people care at every level. Whether you are working with children face-to-face, or behind the scenes supporting the care and services we deliver, you impact futures. Visit us and see why it’s more than just a place to work. It’s a family. Apply today at careers.akronchildrens.org.

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