Clinical Research Assistant

Who are we?

Elixia is a trusted clinical site organization, providing industry-leading patient recruitment and clinical trials management and analysis for Cardiology/Nephrology, Behavioral Health, and Infectious Disease – not just for a single trial, but across your entire therapeutic pipeline.

We are seeking a dedicated Research Assistant to join our team.

Summary: The Research Assistant must have excellent interpersonal, communication, and organizational skills. The Research Assistant must demonstrate the ability to work as part of a team and respond to multiple priorities. The Research Assistant must demonstrate proficiency using a computer and other office equipment.

Office Organization

• Complies with Company handbooks, policies, and procedures.
• Assists the Site Lead, Clinical Research Coordinators, and other Research Assistants in organizing and maintaining the site, which may involve administrative functions including but not limited to:
• entering information in EDC systems (electronic data capture)
• inventory of research and lab supplies
• answering incoming calls
• calling study subjects when necessary
• maintaining a clean office and lab environment
• maintaining and organizing study files
• requesting medical records when needed
• data entry as assigned

Clinical Research

• Inventory protocol shipments, such as drugs, labs, CRFs
• Maintain phone logs of communications with patients and trial sponsors
• Update study logs, including screening, subject identification, and enrollment logs
• Prepare research binders
• Obtain signatures from Principal Investigator(s) and Sub-Investigator(s), as needed
• Update the research CTMS as needed
• Prepare source documents, records, and algorithms
• Assist in preparing documents for submission to the sponsor and IRB
• Obtain blood and other specimens as necessary
• Process lab specimens and prepare lab shipments
• Perform vital assessments of patients and document on designated logs
• Ensure confidentiality of subjects’ health information
• Maintain confidentiality of all subject and protocol information
• Notify Manager of abnormal laboratory values or clinical observations
• Communicate with central lab regarding abnormal lab values
• Perform research study visits as assigned
• Maintain adequate documentation on patient source documents, the Company’s CTMS system, and via e-mail
• Participate in research meetings and provide input
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings
• Perform other duties as assigned by your Manager, Clinical Research Coordinators, or any other member of Management

Qualifications

• Basic knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Knowledge of medical terminology relevant to clinical trials management
• Previous experience in a clinical research settings
• Good Clinical Practice (GCP) Certification
• IATA Certification

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Medical Specialty:

• Infectious Disease
• Nephrology

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Language:

• Spanish (Preferred)

License/Certification:

• Good Clinical Practice Certificate (Required)
• IATA Certification (Required)

Ability to Commute:

• Pontiac, Michigan

Work Location:

In person

Ability to Commute:

• Saint Louis, Missouri

Work Location:

In person