Description: Clinical Research Coordinator 1. Job Identification Job Title Clinical Research Coordinator Reporting to Revathi Pillai Department / CC 1400 Location Paradise Valley/Chandler Job Reference AARA/CRC No. Job Holders 5 Last Update January 2017

2. Job Purpose The Clinical Research Coordinator will support the planning, implementation, and coordination of clinical research studies within the Gastrointestinal (GI) and Endocrinology research studies. Under the supervision of senior research staff and principal investigators, this role ensures that study protocols are followed, data is collected and managed accurately, and all regulatory and ethical standards are upheld. The Coordinator will play a key role in facilitating study participant recruitment, coordinating study visits, maintaining study documentation, and supporting the overall success of GI and endocrinology research initiatives. Additional expectations for this role is travel primarily between Chandler and Paradise Valley to work on GI and Endocrinology studies.

3. Job Dimensions Supervisory/Line Management Authority Has line authority over Clinical Research Assistant. Answers to Regional Research Manager 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, Paylocity

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 GI physicians 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 AARA 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 Associates Degree, or equivalent Must have in-depth knowledge of medical procedures and clinical terminology CPR certified Possess strong organizational skills Ability to develop and maintain strong professional relationships with all providers and research subjects Maintains confidentiality of patient and study information Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations Understands and supports specific State regulations governing clinical research Excellent verbal and written communication skills Ability to lift 20 pounds Willing and able to travel for Investigator Meetings and other AARACR sites