CLINICAL RESEARCH COORDINATOR II (5)

University of Alabama at Birmingham; Birmingham (AL); Sur place; USD 50 050 - 81 330; Plein temps

Résumé du poste

A prominent educational institution in Birmingham, Alabama is seeking a Clinical Research Coordinator II to support cancer research efforts. The role involves coordinating studies, supporting participant eligibility, and conducting activities per protocols. A Bachelor's degree and three years of related experience are required with a salary range of $50,050 to $81,330. The position emphasizes compliance with research regulations and effective communication. Ideal candidates will demonstrate leadership and organizational skills in a clinical setting.

Qualifications

• Three (3) years of related experience required.
• Knowledge of clinical research regulatory/compliance affairs.
• Ability to walk minimally one mile a day and lift up to 15 pounds daily.

Responsabilités

• Serve as coordinator for studies and provide support to team members.
• Conduct activities in accordance with protocol and GCP.
• Assist with the study life cycle, including data collection and participant follow-up.

Connaissances

Clinical research experience

Leadership skills

Problem-solving skills

Organizational skills

Written and verbal communication skills

Ability to work as part of a team

Formation

Bachelor's degree in a related field

Description du poste

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.

Please attach a current resume with this application.

General Responsibilities

• Serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
• Support screening and participant eligibility determination, working with more senior team members to ensure compliance.
• Conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
• Assist with the study life cycle from start‑up to closure: collecting and recording data, recruiting and performing follow‑up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

• Serve as a liaison with medical staff, University Departments, ancillary departments, and/or satellite facilities. Organize patient enrollment planning. Conduct quality assurance activities. Compile and analyze data. Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
• Participate in the recruitment of participants through screening efforts, including the conduct of the consent process according to regulatory guidelines. Coordinate care and/or follow‑up functions of the study, including planning and developing related activities. Arrange access to study medications, as needed, including authorization for prescriptions. Employ strategies to maintain recruitment and retention rates.
• Involved in the study feasibility process and may assist in budget development and billing procedures. Prepare and submit multiple levels of research documentation (IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
• May manage investigational products (IP), including its administration to participants. Employ the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
• In conjunction with Investigators, plan and implement the clinical protocol's goals and objectives. Compile, edit, and proof written reports for both internal and external administrative offices. Provide data for the creation of study budgets as needed.
• Complete Case Report Forms (CRF) according to protocol. Document Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance. Assist with the development of standard operating procedures (SOPs) for data quality assurance.
• Perform 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, develop protocols, identify efficiencies, and improve processes. Serve as a mentor and guide junior staff, including student assistants.
• Maintain compliance with federal, state, and accrediting agencies (sponsors). Maintain any required documentation. Have a working knowledge of institutional and departmental policies and processes.
• Process and maintain lab specimens. Manage site supplies and perform administrative duties in support of research conduction as needed.
• Attend study, departmental, and institutional trainings and meetings as required.
• Perform other duties as assigned.

Annual Salary Range: $50,050 - $81,330

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.
• Leadership skills.
• Presentation skills.
• 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

Organization: 310008400 Comprehensive Cancer Center

Employee Status: Regular

Shift: Day/1st Shift

Work Arrangement: Onsite