The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
SUMMARY: The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Research Supervisor, the Principal Investigator and the Medical Director. The CRC will develop, implement, and coordinate research protocols and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgement, and high level of knowledge of the study’s specific protocols.
DUTIES AND RESPONSIBILITIES:
1. Administratively and clinically manage an average of six to eight clinical trials.
2. Assist in all aspects of study design, implementation, and administration, ensuring compliance with FDA and GCP requirements, Federal/ state regulations, and grant and/or contract parameters.
3. Plans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures. 4. Develops quality standards and programs; monitors and maintains quality of unit performance in accordance with internal policies and standards and grant and/or contract parameters.
5. Develops and/or adapts, implements and evaluates specific research data collection methodologies, protocols, systems, and techniques, as appropriate to the area of research specialty
6. Participates in trials design; may develop and/or coordinate research and computer protocols.
7. Oversees and coordinates data compilation and computation, ensuring quality control and compliance with protocol, review of results for validity and reliability, and provides initial analyses of results to researchers.
8. Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
9. Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations, funding agencies and regulating bodies.
10. Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the
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position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
11. Plans and coordinates the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
12. Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
13. Implements quality control process throughout the conduct of the trial
14. Coordinates the provision of support services to investigators and researchers.
15. Performs miscellaneous job-related duties as assigned.
Education and Experience:
Minimum two years clinical research coordinator experience
Outstanding communication skills, both verbal and written
Experience with EDC systems
Current GCP Certification
Diabetes & Glandular Disease Clinic, P.A.
Job Description
Performance Requirements:
Knowledge, Skills and Abilities Required:
1. Knowledge of the principle, methods, and procedures of basic medical and/or clinical research.
2. Skill in the use of personal computers and related software applications.
3. Ability to analyze and interpret data and prepare evaluative summary reports and correspondence.
4. Advanced knowledge of medical research coordination. Skill in organizing resources and establishing priorities
5. Ability to develop, plan and implement short and long range goals.
6. Ability to maintain quality, safety, and/or infection control standards.
7. Ability to understand and apply specified field and/or laboratory research procedures and protocols.
8. Computer data entry skills.
9. Knowledge of Good Clinical Practice (GCP) guidelines and OSHA standards.
10. Knowledge and understanding of human research policies, regulations, procedures, and standards as applied to IRB and compliance operations.
11. Ability to draw blood and process medical laboratory specimens.
12. Skill in the use of computer spreadsheet and/or database applications in the compilation of research data.
13. Ability to analyze valuates, verify, and edit research data.
14. Knowledge of related accreditation and certification requirements.
15. Ability to maintain subject confidentiality at all times a MUST.
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Work Environment:
1. Work is performed in an interior medical/clinical environment
2. Moderate physical activity. Required handling average-weight objects up to 25 pounds or standing and/or walking for more than four (4) hours per day
3. Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include the use of protective equipment
4. Will work with blood or blood-borne pathogen and will require OSHA training.
About Diabetes & Glandular Disease Clinic, P.A.: The Diabetes & Glandular Disease Clinic, P.A. (DGD) offers the best in treatment for hormonal and metabolic disorders such as type 1 and 2 diabetes, gestational diabetes, thyroid disease, osteoporosis, lipid disorders (high cholesterol), pituitary/adrenal gland problems, menstrual disorders and hirsutism. All our doctors are board-certified in Endocrinology & Metabolism, a sub-specialty of Internal Medicine. Our renowned clinic is located in the South Texas Medical Center. DGD is an Equal Opportunity Employer.