CLINICAL RESEARCH ADMINISTRATOR II (4)

University of Alabama at Birmingham; Birmingham (AL); Hybrid; USD 48,000 - 77,000; Part time

Job summary

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, seeks a Clinical Research Administrator II to support the O'Neal Protocol Review Monitoring System with a strong understanding of contract principles, federal regulations, laws and UAB policies.

Role involves liaising with industry engagement and sponsored programs, managing studies (industry, investigator-initiated, and cooperative group), and facilitating meetings while ensuring regulatory compliance and data

Qualifications

• Bachelor's degree in a related field and three (3) years of related experience required.
• Work experience may substitute for education requirement.
• Knowledge of clinical trial processes.
• Data collection and data entry skills.
• Knowledge of SOPs for data quality assurance.

Responsibilities

• Demonstrates comprehensive understanding of contract principles, federal regulations, laws and UAB policy and operating procedures.
• Acts as liaison to Offices of Industry Engagement and Sponsored Programs in negotiation of CDAs, contracts, and amendments.
• Identifies conflicts of interest, legal, IP and business/financial risk.
• Maintains familiarity with Good Clinical Practice (GCP) guidelines and regulations.
• Schedules meetings, creates agendas, distributes materials, and records minutes.

Skills

Clinical trial knowledge

GCP knowledge

Data entry skills

Education

Bachelor's degree in related field

Job description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Administrator II. The Clinical Research Administrator II will support the O'Neal Protocol Review Monitoring System by demonstrating a comprehensive understanding of contract principles, federal regulations, laws and UAB policy and operating procedures.

The O’Neal Comprehensive Cancer Center is one of 51 NCI-designated “comprehensive” cancer centers in the United States and is the only one in Alabama and in the Deep South region. A “comprehensive” designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival.

On campus and around Birmingham, the O’Neal Cancer Center is a significant part of our economic powerhouse. The O’Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care.

The link to our website is:

https://www.uab.edu/onealcancercenter/

General Responsibilities

• To demonstrate a comprehensive understanding of contract principles, federal regulations, laws and UAB policy and operating procedures.
• To serve as liaison to the UAB Offices of Industry Engagement and Sponsored Programs in negotiation of confidentiality agreements (CDAs), contracts, and amendments related to the conduct of clinical research activities.
• To identify conflicts of interest, legal, IP and business/financial risk.
• To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

Key Duties & Responsibilities

• Serves as liaison between the O'Neal CCC UAB Offices of Industry Engagement and Sponsored Programs (OSP) in negotiating confidentiality agreements (CDAs), contracts, and amendments related to the conduct of clinical research activities. Work with physicians/faculty, divisions, legal, and/or other departments as assigned to 3-4 working groups.
• Maintains knowledge to process studies based on study type, i.e., industry, investigator-initiated, Cooperative Group studies.
• Performs as a meeting facilitator by assisting the WG leads in scheduling the meeting, creating the agenda based on the direction from the WG lead, distributing protocols and other meeting materials, and recording minutes. Agendas and minutes will be maintained on the CCC BOX drive for documentation purposes for all groups.
• Assists in managing other working groups and studies as needed. Works with sponsors/study team to arrange required trainings and meetings. Assists in formulating and implementing the goals for the operation of the research program.
• Performs other duties as assigned.

Annual Salary Range: $47,665 - $77,455

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

• Bachelor’s degree in a science, medical, or clinical-related field preferred.
• Knowledge of clinical trial processes.
• Data collection and data entry skills.
• Knowledge of protocols and standard operating procedures (SOPs) for data quality assurance.
• Assists in managing other working groups and studies as needed.
• Works with sponsors/study team to arrange required trainings and meetings.
• Assists in formulating and implementing the goals for the operation of the research program.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.

Organization

310008400 Comprehensive Cancer Center

Employee Status

Regular

Shift

Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager)

Hybrid Eligible