HRPP/IRB Coordinator

Job Summary

To provide support to the Corporate Director of Clinical Sciences and Research Administration team, primarily upholding the integrity of the institution's Human Research Protection Program.

Provides support and administrative functions for the operations and regulatory requirements for the Institutional Review Board (IRB) and the Institutional Scientific Review Board (ISRB) for CAMC/Vandalia Health System. Administers and oversees policies and procedures that reflect changing regulatory and institutional requirements. Implements, monitors and reports processes to meet AAHRPP accreditation requirements. Serves as a front line reviewer of regulatory requirements for research protocols.

Responsibilities

• Organize office operations and procedures, control and route correspondence, maintain filing systems, review and approve supply requisitions, perform clerical functions.
• Maintain procedures for retention, protection, retrieval, transfer, and disposal of records.
• Prepare and analyze special reports, summarize information, identify trends.
• Maintain competencies required by position, identify and follow through on educational development needs including attendance at educational events and reviewing relevant publications.
• Act as front line contact for all internal and external customers, serving as help desk, conflict resolution resource, and distribution center.
• Maintain customer confidence and protect operations by keeping information confidential.
• Facilitate calendars for department and/or personnel.
• Arrange preparations for meetings, conferences, teleconferences, or other department events.
• Maintain office supply inventory by checking stock to determine inventory level, anticipate needed supplies, place and expedite orders for supplies, verify the receipt of supplies.
• Keep equipment operational by following manufacturer's instructions and established procedures.
• Complete assigned projects.
• Preserve and monitor time of departmental and/or grant personnel.
• Assist with the daily operations of the Institutional Review Board (IRB) and Institutional Scientific Review Board.
• Assist with maintaining the Association for the Accreditation of Human Research ProtectionProgram accreditation.
• Assist in daily operations of IRB and ISRB, including developing an expertise in the software used to maintain the HRPP.
• Assist in the work of the Central IRB.
• Plan and attend all IRB and ISRB meetings and secure preparation of minutes for approval.
• Responsible for input of protocol and other correspondence into research data base and responsible for maintaining all database systems for protocols as well as reporting.
• Distributes forms (e.g.s, voting ballots, meeting materials) to IRB and ISRB members. Communicate needed revisions.
• Works to ensure research process meets all federal compliance regulations to include accrediting body, corporate compliance and other regulatory and policy processes and procedures.
• Assist in developing a comprehensive human subjects research educational program to include research compliance issues and education for potential researchers, researchers, research coordinators, students, residents, staff, IRB and ISRB, etc.
• Assist in providing educational materials and educational programs for multiple users in different settings to include in-person and online training and multiple media training to focus on research review process and procedures, policy, compliance, etc.
• Assist in developing and maintaining monitoring and auditing processes as may be required by the accreditation or institutional requirements.
• Participate and assist in guiding the continuous, quality improvement activities of the department and institution.

Knowledge, Skills & Abilities

Patient Group Knowledge (Only applies to positions with direct patient contact)

The employee must possess/obtain (by the end of the orientation period) and demonstrate the knowledge and skills necessary to provide developmentally appropriate assessment, treatment or care as defined by the department's identified patient ages. Specifically the employee must be able to demonstrate competency in: 1) ability to obtain and interpret information in terms of patient needs; 2) knowledge of growth and development; and 3) understanding of the range of treatment needed by the patients.

Competency Statement

Must demonstrate competency through an initial orientation and ongoing competency validation to independently perform tasks and additional duties as specified in the job description and the unit/department specific competency checklist.

Common Duties and Responsibilities

(Essential duties common to all positions)

1. Maintain and document all applicable required education.

2. Demonstrate positive customer service and co-worker relations.

3. Comply with the company's attendance policy.

4. Participate in the continuous, quality improvement activities of the department and institution.

5. Perform work in a cost effective manner.

6. Perform work in accordance with all departmental pay practices and scheduling policies, including but not limited to, overtime, various shift work, and on-call situations.

7. Perform work in alignment with the overall mission and strategic plan of the organization.

8. Follow organizational and departmental policies and procedures, as applicable.

9. Perform related duties as assigned.

Education

• Bachelor's Degree (Required)

Substitution: May substitute Associates Degree with 2 years of related experience for Bachelor's Degree

Preference: Word, PowerPoint and Excel skills

Credentials

• No Certification, Competency or License Required

Work Schedule: Days

Status: Full Time Regular 1.0

Location: Chesterfield Bldg 4-Center for Learning & Research

Location of Job: US:WV:Charleston

Talent Acquisition Specialist: Tamara B. Young tammy.young@vandaliahealth.org