Clinical Research Technician Underfill Assistant-Term Limited

Michigan Medicine is hiring a Clinical Research Technician, with possible underfill as a Clinical Research Assistant, to support clinical research studies. The role coordinates study activities and supports participant screening and visits, data collection, regulatory documentation, specimen management, and research administration.

Responsibilities

• Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases
• Performs simple study procedures with accuracy
• Understands protocol structure and how to interpret study requirements to ensure study compliance
• Understands proper documentation techniques as outlined in the ICH-GCP guidelines
• May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team
• Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC
• May mark visits as planned/occurred in OnCore
• May provide lab results, not interpretation, to participants
• May maintain essential regulatory documents
• May assist research coordinator in conduct of SIV; attends SIV
• May assist in and attends monitor visits and or audits
• May conduct site selection/qualification visits for potentially incoming clinical trials
• Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information)
• Enters data to complete forms (CRFs) on paper, databases, or EDCs
• Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned
• May administer minimal risk consents, surveys, and questionnaires
• Checks own work and confirms accuracy
• Demonstrates ability to perform concomitant medications abstraction
• Uses various NCI AE grading scales
• Builds patient research study charts
• Demonstrates ability to resolve simple queries
• Assists in quality control efforts (e.g., review of consents for signatures)
• May work with regulatory support to collect essential documents and maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.); Assists with AEs and SAEs, ORIOS reporting; Uses proper documentation techniques as outlined in the ICH-GCP guidelines
• Demonstrates understanding of the clinical research objectives associated with the program
• May communicate with study participants such as sending study correspondence via mail or email
• May schedule subjects for research visits and FU appointments
• May check study calendar for completion of study procedures
• May manage study supply inventory
• May utilize documents and systems to track recruitment and retention of participants
• May complete and activate postings (advertisements, flyers, etc.) independently
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.]
• Willing to learn and use available technology and systems to accomplish job requirements
• Understands the disease process per program
• Attends and participates in all training classes assigned to this level
• Demonstrates proficiency in eResearch duties as assigned
• Uses proper documentation techniques as outlined in the ICH-GCP guidelines.May gather participant approval via a simple consent
• May assess participant understanding of the research during the consent process and can therefore consent to the study
• Demonstrates ability to identify AEs and SAEs, ORIOS, and assists with reporting
• May submit continuing reviews, amendments, and post correspondence in eResearch
• Demonstrates familiarity with essential documents as described in the ICH-GCP guidelines
• Demonstrates the ability to understand the completion and submission of eResearch and OnCore applications
• Can explain the basic requirements of an Informed Consent and the importance of such a documentregarding the safety and ethical treatment of participants
• Identifies key regulations and guidelines in FDA and ICH documents that ensure ethical conduct in clinical trials
• Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
• Demonstrates professional behavior and ethical integrity through the applications
• Suggests modifications to improve efficiency of workload and/or workflow
• May assist research team in the conduct of site initiation meetings
• May conduct site selection/qualification visits for potentially incoming clinical trials
• May communicate with MCRU or other staff completing specimen management to collect data (e.g., pick up/retrieve CRFs from staff, track packages, etc.)
• Ensures integrity of specimen management (collection, processing, packaging/shipping, storing, labeling, tracking, etc.)
• Is familiar with basic clinical lab equipment such as a centrifuge, freezers (various), pipettes, and standard laboratory safety requirements and guidelines
• May prepare study procedure kits, shippers, CRFs, and requisition forms
• Perform other related duties as assigned
• Performs moderately complex study procedures with accuracy
• Triages simple subject concerns and issues appropriately
• Assesses studies for execution and troubleshoots potential implementation issues
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits
• Completes simple to moderately complex data collection during study visits
• May work with CTSUs to reconcile financial accounts for study participants
• Assists with local quality control efforts
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment
• May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov
• May obtain the CTN number for eResearch applications
• Completes simple to moderately complex CRFs
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials
• May complete new eResearch applications
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines
• May gather participant approval via informed consent
• Prepares and participates in internal and external audits
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately
• Demonstrates understanding of the clinical research objectives associated with the program
• May communicate with study participants such as sending study correspondence via mail or email
• May schedule subjects for research visits and FU appointments
• May check study calendar for completion of study procedures
• May manage study supply inventory
• May utilize documents and systems to track recruitment and retention of participants
• May complete and activate postings (advertisements, flyers, etc.) independently
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)
• All training requirements of previous level
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned
• Willing to learn and use available technology and systems to accomplish job requirements
• Understands the disease process per program
• Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others

Preferred

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable
• Associate Degree in Health Science
• Bachelor's Degree in Health Science
• Related Education
• Medical Terminology
• Complex Healthcare Setting Experience
• University Policies
• Effective Communication

Benefits

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 match on retirement savings

Company

• Academic medical center and health care system
• Ann Arbor, Michigan, USA
• http://www.uofmhealth.org/
• Founded in 1850
• 10001+ employees

Qualifications

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary (Please review SoCRA?s [Definition of a Clinical Research Professional](https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.socra.org%2Fcertification%2Fcertification-program%2Fdefinition-of-a-clinical-research-professional%2F&data=05%7C02%7Ceddimaur%40med.umich.edu%7C1b822d89a7094b16e0d508dbfccb1f05%7C1f41d613d3a14ead918d2a25b10de330%7C0%7C0%7C638381721546932550%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwIiwjJ9&reserved=0) for qualifying experience prior to applying.)
• An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD
• Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research
• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable

Required skills

• Clinical Research, Clinical Trials, Human Subjects Research

Experience

• 1-3 years