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Clinical Research Specialist

Job Description

IU Psychotic Disorders Program (IUPDP) is designed to serve Indiana as a center of clinical, research, and educational excellence in the treatment of individuals diagnosed with schizophrenia and other psychotic illnesses. The position is for a full time research specialist who will assist in the coordination of clinical trials and research studies of those diagnosed with schizophrenia. IUPDP has two clinic locations, our chronic clinic located within Larue Carter known as the Psychotic Disorders Clinic and our early intervention clinic known as the PARC clinic, which is a division of Midtown Community Mental Center and is located in Eskenazi Hospital. 

This position is for a clinical research specialist who will be housed at PARC. The duties of this position include, but are not limited to the following: recruit subjects, complete scheduled visits, coordinate study visits with doctors, nurses, and outside vendors such as Eskenazi ECG services, IU radiology clinic, CTSI blood bank, etc, schedule & coordinate study-related meetings with the team, conduct weekly staff meetings/rounds to update the staff of the progress of the trials and take meeting minutes, work with Eskenazi regulatory and research services in order to set up new studies, work with the IRB, create source documentation, create and maintain databases through REDcap, and complete data entry 

Duties and responsibilities: 

•Schedule and/or coordinate study-related meetings, training sessions and pre-study visit of sponsor/s. Develop advertising and other information materials for recruitment. 

•Compose and supervise preparation of regulatory and source documents. Assist in the consenting of subjects and ensure that Informed Consent forms are properly signed before the start of the study. Extract data from source documents to compete Case Report Forms (CRF) or database entries. Resolve sponsor queries related to CRFs and regulatory documents. 

•Assign drug and/or device supplies to research subjects. Maintain files of drug and/or device accounting, compliance, and return. Assist in ordering drug/device supplies. Oversee the proper handling of laboratory specimens including processes, shipping, storage, and documentation. 

•Contact outside health-care providers to obtain follow-up information. Communicate with subjects to obtain follow-up information. 

•Review incoming subject adverse event (SAE) information and assist PI in making submission and/determination of SAEs. Capture and record adverse events data and compose reports for oversight agencies. 

•Compose and submit continuing review/amendments/close out information. Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meeting. 

Qualifications:
Required: Bachelor’s degree from an accredited institution in Science or health-related field with at least 1 year health-related or research experience; or any Bachelor’s degree from an accredited institution or an Associate’s degree from an accredited institution in an Allied Health profession with 3 years of health-related or research experience or 2 years of experience in clinical research. 

Master's degree from an accredited institution in Psychology, Social Work, or Counseling with at least one year clinical counseling experience and license eligibility is strongly preferred. 

Clinical experience with adult psychotic disorders is preferred. Clinical Research Certification desired. 

Excellent oral and written communication skills; Experience in clinical trials with human subjects, working knowledge of psychiatric disorders; Experience with research methods; ability to problem solve and possess skills of attention to detail. 

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Care Coordinator

Eskenazi Health

Job Description

The Prevention and Recovery Center for Early Psychosis (PARC) is an outpatient clinic designed to serve Indiana as a center of clinical, research, and educational excellence in the treatment of Individuals in the early stages of schizophrenia and other psychotic illnesses. The Care Coordinator, in collaboration with the MD/CNS and treatment team, formulates, develops and revises treatment plans. The Care Coordinator prioritizes and subsequently coordinates treatment activities and inteviews patients and significant others to gather information for Biopsychosocial Updates and ANSA/CANS assessments and completes them accurately and in a timely manner. This position is affiliated with Eskenazi Health Midtown Community Mental Health and is located in the Sidney & Lois Eskenazi Hospital.

Qualifications

-Bachelor's degree in social work, substance abuse, education, counseling, psychology, sociology, criminal justice or related field 
-Minimum of one year related work experience 
-May substitute a Master's degree in social work, substance abuse, education, counseling, psychology, sociology, criminal justice or related field if no prior experience in mental health
-Valid Indiana driver's license

Employment Type

Full-time

Schedule

Flexible

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