CLINICAL RESEARCH COORDINATOR II (3)

University of Alabama at Birmingham; Birmingham, Northern (AL, KY); Hybrid; USD 50,000 - 81,000; Full time

Job summary

University of Alabama at Birmingham seeks a Clinical Research Coordinator II to manage study activities under the Investigator’s oversight. Responsibilities include screening, enrollment, data collection, and regulatory submissions within GCP.

The role supports budgeting, IP management, and coordination of oncology trials, working with diverse teams to ensure protocol adherence. The position requires a Bachelor's degree and three years of related experience, with clinical research experience

Qualifications

• Bachelor's degree in a related field; three (3) years of related experience required (work experience may substitute for education).
• Clinical research experience preferred.
• Ability to lead others in coordinating oncology clinical trials.
• Knowledge of regulatory/compliance affairs in clinical research.

Responsibilities

• Serve as liaison with medical staff and departments; organize patient enrollment planning and quality assurance activities.
• Assist with screening and eligibility by following protocol and GCP guidelines.
• Handle data collection, CPRF completion, AE/SAE documentation, and study documentation.
• Coordinate study budget development, IP management, and regulatory submissions (IRB/FDA) as needed.
• Support lab and fieldwork, schedule visits, and assist in protocol implementation and SOP development.

Skills

Clinical research experience

Regulatory knowledge

Team leadership

Communication skills

EMR basics

Education

Bachelor's degree in a related field

Job description

Job Description - CLINICAL RESEARCH COORDINATOR II (7) (T234611)

CLINICAL RESEARCH COORDINATOR II (7) - ( T234611 )

Description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Coordinator II.

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 serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.

To support screening and participant eligibility determination, working with more senior team members to ensure compliance.

To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).

To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

Serves as a liaison with medical staff, University Departments, ancillary departments, and/or satellite facilities. Organizes patient enrollment planning. Conducts quality assurance activities. May compile and analyze data. Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.

Participates in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines. Coordinates care and/or follow-up functions of the study, including planning and developing related activities. Arranges access to study medications, as needed, including authorization for prescriptions. Employs strategies to maintain recruitment and retention rates.

Involved in the study feasibility process and may assist in budget development and billing procedures. Prepares and submits multiple levels of research documentation (i.e., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).

May manage investigational products (IP), including it’s administration to participants. Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.

In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives. Compiles, edits, and proofs written reports for both internal and external administrative offices. Provides data for the creation of study budgets as needed.

Completes Case Report Forms (CRF) according to protocol. Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance. Assists with the development of standard operating procedures (SOPs) for data quality assurance.

Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures and assist in developing orders in the Electronic Medical Record (EMR).

Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes. Serves as a mentor and guides junior staff, including student assistants.

Maintains compliance with federal, state, and accrediting agencies (sponsors). Maintains any required documentation. Has a working knowledge of institutional and departmental policies and processes.

Processes and maintains lab specimens. Manages site supplies and performs administrative duties in support of research conduction as needed.

Attends study, departmental, and institutional trainings and meetings as required.

Performs other duties as assigned.

Annual Salary Range

$50,050 - $81,330

Qualifications

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

Preferences

Clinical research experience.

Ability to lead others in the coordination of research activities involved in conducting Oncology clinical trials.

Knowledge of clinical research regulatory/compliance affairs.

Problem-solving skills.

Working knowledge of related scientific and clinical terminology.

Prioritization skills.

Organizational skills.

Written and verbal communication skills.

Ability to work as part of a team.

Ability to walk minimally one mile a day and lift up to 15 pounds a daily.

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.

Primary Location

University

Job Category

Clinical Research

Employee Status

Regular

Shift : Day/1st Shift

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