Clinical Research Coordinator Ii Job University area,Florida USA,Healthcare

Position: CLINICAL RESEARCH COORDINATOR II (4)

CLINICAL RESEARCH COORDINATOR II (2) (T227690)

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

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. 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.

For more information visit https://(Use the "Apply for this Job" box below)..

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 satellite facilities. Organize patient enrollment planning. Conduct quality assurance activities. May 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 follow‑up functions of the study, arranging access to study medications and employing 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, FDA submissions, educational materials, reports, grant renewal reports, and study forms).

May manage investigational products (IP), including their administration to participants, employing the required system 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 internal and external 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. Assist with the development of 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 EMR.

Under the oversight of the investigator, develop protocols, identify efficiencies, and improve processes. Serve as a mentor and guide junior staff.

Maintain compliance with federal, state, and accrediting agencies. Maintain documentation and have working knowledge of institutional policies and processes.

Process and maintain lab specimens. Manage site supplies and perform administrative duties in support of research conduct as needed.

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

Perform 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 the 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.
Abili…


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