The Center Birmingham
CLINICAL RESEARCH COORDINATOR II
The Center Birmingham, Birmingham, Alabama, United States, 35275
CLINICAL RESEARCH COORDINATOR II (T228433)
The University of Alabama at Birmingham (UAB), OB/GYN – Maternal & Fetal Medicine, is seeking a Clinical Research Coordinator II. Responsibilities include patient screening, recruiting participants for specific studies, and processing and maintaining lab specimens. The candidate must be willing to alternate between day and night shifts. 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 coordinating 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; may compile and analyze data. Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected for MFM studies. Maintain compliance with federal, state, and accrediting agencies (sponsors). Maintain any required documentation; have a working knowledge of institutional and departmental policies and processes. Participate in the recruitment of participants through screening efforts, including the conduction 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 (e.g., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms). May manage investigational products (IP), including their 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 provide guidance to junior staff, including student assistants. 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 Qualifications
Bachelor’s degree in a related field and three (3) years of related experience required.
Work experience may substitute for education requirement. Preferences
Candidate must have effective verbal and written communication. This position requires working independently as well as within a team. Shift
Rotation / Flexible Staffing / Multiple Shifts EEO Statement
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, ethnicity 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.
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The University of Alabama at Birmingham (UAB), OB/GYN – Maternal & Fetal Medicine, is seeking a Clinical Research Coordinator II. Responsibilities include patient screening, recruiting participants for specific studies, and processing and maintaining lab specimens. The candidate must be willing to alternate between day and night shifts. 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 coordinating 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; may compile and analyze data. Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected for MFM studies. Maintain compliance with federal, state, and accrediting agencies (sponsors). Maintain any required documentation; have a working knowledge of institutional and departmental policies and processes. Participate in the recruitment of participants through screening efforts, including the conduction 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 (e.g., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms). May manage investigational products (IP), including their 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 provide guidance to junior staff, including student assistants. 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 Qualifications
Bachelor’s degree in a related field and three (3) years of related experience required.
Work experience may substitute for education requirement. Preferences
Candidate must have effective verbal and written communication. This position requires working independently as well as within a team. Shift
Rotation / Flexible Staffing / Multiple Shifts EEO Statement
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, ethnicity 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.
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