Clinical Data Coordination
The Certificate of Completion (CCL) in Clinical Data Coordination provides students an understanding of the steps involved in clinical data management from study site planning, preparation, data extraction for analysis, reporting of clinical trials, with emphasis on tracking deadlines and milestones. Courses include competencies in design and development of databases, maintenance of required documentation, standard operating procedures (SOPs), and quality control. In addition, the Clinical Data Coordination program ensures compliance with data security and confidentiality, federal laws and regulations in the conduct of research. Students will gain substantive knowledge in how to monitor clinical trials; as well as when, why, and how to engage clinical research organizations (CROs).
Details
Permission of the Program director
Students must earn a grade of C or better in all courses within the program.
This pathway map will help you gain the expertise needed to:
- Demonstrate general understanding of the `Common Rule` and requirements for sites and sponsors participating in clinical trials.
- Describe the roles and responsibilities of the clinical investigation team as defined by Good Clinical Practice Guidelines.
- Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical trials.
- Discuss the historical events and ethical issues impacting vulnerable populations which precipitated the development of governmental regulatory processes for drugs, devices and biologicals.
- Complete sample, "Statement of Investigator Federal Form 1572" and addendums for conflict of interest for a clinical research site.
- Explain the operational and data preparations required for a regulatory site audit and its purpose.
- Identify physical and non-physical risks associated with research subjects.
- Explain the Institutional Review Board (IRB) review criteria for expedited, minimal risk, and exempt studies.
- Analyze the ethical and moral conflicts between local communities and research initiatives.
- List the documents required for a clinical research site regulatory binder.
- Compare and contrast a clinical study case report form designs and production formats.
- Describe the required protocol components documents needed for an IRB new protocol review application.
- Summarize the legislative and regulatory framework which supports the development and registration of medicines, devices and biological and ensures their safety, efficacy and quality.
Successful completion of this certificate may lead to employment in a variety of different occupations and industries. Below are examples of related occupations with associated Arizona-based wages* for this certificate. Education requirements vary for the occupations listed below, so you may need further education or degrees in order to qualify for some of these jobs and earn the related salaries. Please visit with an academic advisor and/or program director for additional information. You can click on any occupation to view the detail regarding education level, wages, and employment information.
Clinical Research Coordinators
$133,350 Show expanded career information for Clinical Research Coordinators
Course Sequence by Term
The following is the suggested course sequence by term. Please keep in mind:
- Students should meet with an academic advisor to develop an individual education plan that meets their academic and career goals. Use the Pathway Planner tool in your Student Center to manage your plan.
- The course sequence is laid out by suggested term and may be affected when students enter the program at different times of the year.
- Initial course placement is determined by current district placement measures and/or completion of 100-200 level course and/or program requirements.
- Degree and transfer seeking students may be required to successfully complete a MCCCD First Year Experience Course (FYE) within the first two semesters at a MCCCD College. Courses include FYE101 and FYE103. Course offerings will vary by college. See an academic, program, or faculty advisor for details.
Full-time Sequence
Full-time status is 12 credits to 18 credits per semester.
Term 1
Course Number | Course Name | Requisites | Notes | Area | Credits |
---|---|---|---|---|---|
CIS114DE | Excel Spreadsheet | 3 | |||
CRC101 | Introduction to Clinical Research | 4 | |||
CRC102 | Clinical Research Regulations | 4 | |||
HCC145 or HCC146 | Medical Terminology for Health Care Professionals or Common Medical Terminology for Health Care Professionals | 2–3 | |||
CRC103 | Research Design and Data Management | 4 |
Students must earn a grade of C or better in all courses within the program.
Course Sequence total credits may differ from the program information located on the MCCCD curriculum website due to program and system design.
View MCCCD’s official curriculum documentation for additional details regarding the requirements of this award (https://aztransmac2.asu.edu/cgi-bin/WebObjects/MCCCD.woa/wa/freeForm11?id=187456).
At Maricopa, we strive to provide you with accurate and current information about our degree and certificate offerings. Due to the dynamic nature of the curriculum process, course and program information is subject to change. As a result, the course list associated with this degree or certificate on this site does not represent a contract, nor does it guarantee course availability. If you are interested in pursuing this degree or certificate, we encourage you to meet with an advisor to discuss the requirements at your college for the appropriate catalog year.