Clinical Research Coordinator at ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES Avondale, AZ
ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES
Behavioral Health Market Context
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Job Description
TBC
3. Job Dimensions
Supervisory/Line Management Authority
Has line authority over Clinical Research Assistant. Answers to Director of Clinical Research
Area Authority
Has limited authority over methods used in collecting data
Financial Authority
Has no financial authority
Process Authority
Has limited process authority when scheduling patients
Patient Contact
Varying amounts of patient contact
4. Organizational Position
Insert as appropriate from Org. Chart
5. Role of the Department
7. Equipment, Machinery and Systems
Abbott Architect ci4100 Chemistry/Immunoassay Analyzer
Abbott Cell-Dyn Ruby Haematology Analyzer
Alcor iSED Sedimentation Rate Analyzer
Dynex DS2 Analyzer
Mago 4S Analyzer
Barcode Reader
Lab Equipment List
IT Equipment List
Systems, Software and Programs
Laboratory Information System (LIS): Compugroup CGM LabDaq LIS
MS Office
AllScripts, Paycom
6. Key Result Areas
• Provides study information and obtains relevant information as required by the protocol, from patients who are participating in, or interested in clinical studies.
• Assists in the recruitment and screening of volunteers, schedules patient visits in EMR, provides information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person. Collects relevant medical records when needed.
• The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
• Reviews and administers the informed consent form to subjects; allowing them time to read and ask questions. Provides progress notes in EMR and source documents to describe procedures at each visit.
• Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
• Obtaining patient medical history and medication lists
• Phlebotomy and basic laboratory tests
• Patient education and training
• ECG
• Administer Questionnaires
• Vital signs
• Assist with Joint counts and other assessments
• Data Entry
• Study drug administration, including injections
• Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events. Follow-up with the subject and collateral informants as needed.
• Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
• Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process.
• Serves as a liaison to all physicians and AARA employees.
• Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.
• May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
• Provides all AARR research subjects with an excellent service experience by consistently demonstrating professional decorum
8. Assignment and Review of Work
All new AARA employees will agree initial objectives to be assessed on completion of their 90-day initial review period. Thereafter, all employees will enter the annual appraisal cycle under the AARA Talent, Performance and Career Management Policy where annual appraisals will be conducted by their Line Manager and CEO. Further information on the appraisal cycle calendar is available from the HR Manager and from the Talent, Performance and Career Management Policy on the AARA Intranet.
9. Communication and Relationships
The postholder must have strong interpersonal and relational talents. Success in this role involves building and maintaining relationships with internal and external stakeholders
Key Internal Relationships
Director of Research
Lab Technicians (Direct Reports)
Phlebotomists (Direct Reports)
Key External Relationships
Patients
Outside labs
Vendors
10. Demands of the Job
Role requires frequent light physical effort. The role requires a combination of sitting, standing and walking.
Role requires frequent, moderate mental effort. The role requires a consistent high level of concentration, attention to detail and organization.
Role requires frequent, light emotional exposure to distressing diagnoses. Occasional direct moderate emotional exposure to patients or relatives who may be ill, upset, distressed or angry.
Role requires frequent exposure to hazardous materials and contact with contained bodily fluids.
Requirements:
11. Knowledge, Skill, Training and Experience to do the Job
Essential
• BS in science related field
• Clinical Research Coordinator Certification, (CRCC
• Experience of bio-sample handling and management. Research experience preferred.
• 3 years clinical lab or acute care setting experience with minimum of 2 years clinical research experience.
Desirable
Qualifications
- •Abbott Architect ci4100 Chemistry/Immunoassay Analyzer
- •The postholder must have strong interpersonal and relational talents
- •Success in this role involves building and maintaining relationships with internal and external stakeholders
- •The role requires a consistent high level of concentration, attention to detail and organization
- •Knowledge, Skill, Training and Experience to do the Job
- •BS in science related field
- •Clinical Research Coordinator Certification, (CRCC
- •Experience of bio-sample handling and management
Benefits
Responsibilities
- •Has line authority over Clinical Research Assistant
- •Answers to Director of Clinical Research
- •Has limited authority over methods used in collecting data
- •Has limited process authority when scheduling patients
- •Patient Contact
- •Varying amounts of patient contact
- •Organizational Position
- •Equipment, Machinery and Systems
- •Dynex DS2 Analyzer
- •Barcode Reader
- •Provides study information and obtains relevant information as required by the protocol, from patients who are participating in, or interested in clinical studies
- •Assists in the recruitment and screening of volunteers, schedules patient visits in EMR, provides information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person
- •Collects relevant medical records when needed
- •The CRC is responsible for meeting recruitment goals for each study
- •The methodology of recruitment will include, but is not limited to daily chart review, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach
- •Reviews and administers the informed consent form to subjects; allowing them time to read and ask questions
- •Provides progress notes in EMR and source documents to describe procedures at each visit
- •Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
- •Obtaining patient medical history and medication lists
- •Phlebotomy and basic laboratory tests
- •Patient education and training
- •ECG
- •Administer Questionnaires
- •Vital signs
- •Assist with Joint counts and other assessments
- •Data Entry
- •Study drug administration, including injections
- •Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events
- •Follow-up with the subject and collateral informants as needed
- •Provides educational information to subjects
- •Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program
- •Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner
- •Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner
- •May participate in the annual IRB approval and update process
- •Serves as a liaison to all physicians and AARA employees
- •Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment
- •May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner
- •Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards
- •Provides all AARR research subjects with an excellent service experience by consistently demonstrating professional decorum
- •Assignment and Review of Work
- •All new AARA employees will agree initial objectives to be assessed on completion of their 90-day initial review period
- •Thereafter, all employees will enter the annual appraisal cycle under the AARA Talent, Performance and Career Management Policy where annual appraisals will be conducted by their Line Manager and CEO
- •Role requires frequent light physical effort
- •The role requires a combination of sitting, standing and walking
- •Role requires frequent, moderate mental effort
- •Role requires frequent, light emotional exposure to distressing diagnoses
- •Occasional direct moderate emotional exposure to patients or relatives who may be ill, upset, distressed or angry
- •Role requires frequent exposure to hazardous materials and contact with contained bodily fluids
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