Clinical Research Coordinator I

Akron Children's; Akron, Northern (OH, KY); Híbrido; USD 55 000 - 75 000; Tempo integral

Resumo da oferta

Akron Children’s is seeking a Clinical Research Coordinator I to support multiple studies under supervision. You will coordinate daily trial activities, screen and consent participants, and ensure compliance with IRB, GCP, and regulatory requirements.

The role requires a Bachelor's in a health-related field, BLS, CITI, and IATA/DG certifications within 90 days. A hybrid work setup and collaboration with the ACH Research team are expected.

Qualificações

• Bachelor's degree in health-related field required.
• BLS, CITI, IATA/Dangerous Goods certifications due within 90 days.
• Experience in healthcare preferred; clinical research experience preferred.

Responsabilidades

• Recruit, screen, enroll and obtain consent/assent from participants.
• Adhere to GCP, IRB and regulatory guidelines.
• Ensure regulatory compliance and proper data collection/documentation.
• Develop source documents and manage data entry in sponsor and ACH databases.
• Support regulatory document management and study submissions.
• Ensure credentialing and training of the research team.
• Communicate study requirements to stakeholders.
• Handle specimen processing/shipping per protocol.
• Utilize CTMS and monitor protocol budgets.
• Occasional travel for sponsor trainings.

Conhecimentos

GCP knowledge

HIPAA compliance

Data abstraction

CTMS usage

Formação académica

Bachelor's degree in health-related field

Ferramentas

EPIC

CTMS

Electronic Health Records

Microsoft Office

Descrição da oferta de emprego

Full-time, 40 hours/week

Monday-Friday 8am-4:30pm

Hybrid remote

Summary:

The Clinical Research Coordinator I (CRC I) is a specialized research professional working with and under the direction of the Clinical Research Support Team Supervisor and Clinical Principal Investigator (PI) on multiple ongoing research studies. While the PI is ultimately responsible for the clinical trial, the CRC I is responsible for the facilitation and coordination of the daily clinical trial activities in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals and Akron Children’s Hospital (ACH) policies and procedures. The CRC I plays a critical role in the conduct of the study and works collaboratively with the entire ACH Research team, sponsors, and monitors to ensure productivity and timely completion of studies.

Responsibilities:

1. Recruit, screen, enroll and obtain consent/assent from research participants.
2. Utilizing Good Clinical Practice, ensures assigned studies are conducted in accordance with IRB and regulatory agency regulations.
3. Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
4. Develops source documents, completes timely and accurate data collection, documentation, entry, and reporting in both sponsor and ACH databases.
5. Supports the regulatory document specialist in the maintenance of regulatory documents, study submissions and continuing reviews in accordance with Rebecca D. Considine Research Institute (RDCRI) SOP and policies and applicable regulations.
6. Ensures appropriate credentialing and training of the entire ACH research team.
7. Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsors, monitors, PIs, and study participants.
8. Ensures proper specimen handling, processing, and shipping according to protocol.
9. Utilizes the Clinical Trial Management System (CTMS) and adheres to protocol specific budgets.
10. Occasional travel to attend sponsor study training meetings (required).
11. Other duties as required.

Other information:

Technical Expertise:

1. Knowledge of clinical trial protocols is preferred.
2. Competency in interpreting medical charts and abstracting data is preferred.
3. Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.
4. Competency in the use of Microsoft Office, Word, and Excel, Electronic Health Systems, EPIC and databases utilized in research or have a willingness to learn and demonstrate proficiency within six months of hire.

Education and Experience:

1. Education: Bachelor's degree in health-related field is required.
2. Certification: None.
3. Years of relevant experience: None required. Prefer some previous clinical research experience.
4. Experience in healthcare is preferred.
5. Basic Life Support (BLS) – Certification is required within 90 days of employment. Akron Children’s will facilitate training.
6. CITI Certification – Certification is required within 90 days of hire.
7. International Air Transport Association (IATA)/Dangerous Goods Shipping certification is required within 90 days of hire.
8. Ability to work independently as well as in a team environment.

Full Time

FTE: 1.000000

Status: Fixed Hybrid