Clinical Research Coordinator I

Akron Children's Hospital; Akron (OH); Híbrido; USD 50 000 - 65 000; Tempo integral

Resumo da oferta

Akron Children's Hospital is seeking a Clinical Research Coordinator I to support multiple studies under supervision. You will recruit and consent participants, ensure regulatory compliance, manage data in sponsor and ACH databases, and assist with regulatory submissions.

The CRC I will work within a hybrid schedule (Mon-Fri, 8:00am-4:30pm) and may travel for sponsor trainings. A health-related bachelor's degree is required, with GCP/HIPAA knowledge and basic research experience preferred.

Qualificações

• Bachelor's degree in health-related field required.
• Knowledge of GCP, HIPAA, and regulatory standards.
• Experience with data abstraction and chart review beneficial.
• Ability to work independently and in a team.

Responsabilidades

• Recruit, screen, enroll and obtain consent/assent from research participants.
• Ensure studies are conducted in accordance with IRB and regulatory regulations (GCP).
• Ensure site compliance with protocols and regulatory requirements.
• Develop source documents and data collection, reporting in sponsor and ACH databases.
• Support regulatory document management and submissions.
• Ensure credentialing and training of the ACH research team.
• Communicate study requirements to the research team, sponsors, monitors, and participants.
• Ensure proper specimen handling, processing, and shipping per protocol.
• Utilize CTMS and adhere to protocol budgets.
• Occasional travel to sponsor study trainings.

Conhecimentos

GCP regulations

HIPAA compliance

Data abstraction

Regulatory knowledge

Team collaboration

Formação académica

Bachelor's degree in health-related field

Ferramentas

EPIC

CTMS

Microsoft Office

Excel

EHR systems

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