Clinical Research Specialist

Job Summary

Department Specific Responsibilities

• Serves as Office Manager.
• Primary liaison for study teams at the Goodman Hall CRC and a point-of-contact at the University Hall CRC.
• Evaluates office production, revises procedures, or devises new procedures to improve efficiency of workflow.
• Organizes office operations and procedures, such as creating Word or Excel files, bookkeeping, and preparation of billing, flow of correspondence, filing, requisition of supplies, and other office services.
• Manages patient check-in and check-out, centralized scheduling, maintenance of patient records, and compliant use of WebCamp (census/scheduling system) and REDCap (participant visit requests).
• Oversees opening, sorting, and routing of incoming mail, prepares outgoing mail.
• Purchases and maintains office supplies and equipment using BUY.IU.
• Orders and maintains clinical supplies and equipment using the IU Health system, Oracle.
• Assists with coordinating study procedures.
• Trains study team staff on completing CRC visit requests using REDCap as well as general CRC use.
• Monitors study team staff activity to ensure CRC procedures are being followed.
• Communicates with study team regarding study visit requests: approval, disapproval or if changes are required.
• Assists with developing various communications and strategies.
• Audits and reviews CRC source documents to ensure accuracy and quality.
• Assists with creation of source document tools.
• Assists with billing compliance audits.
• May work on office projects engaging others to collaborate and accountable to see through to completion.
• May allocate tasks and assignments to lower-level appointed staff (students) and monitors their performance.
• Performs various study activities based on protocols which includes obtaining vital signs, blood draws, electrocardiograms, height, and weight. Places intravenous catheters.
• Assists nurse with investigational drug infusions and infusion-related adverse drug reactions as well as other adverse events.
• Completes point-of-care testing such as urine pregnancy, urinalysis, blood glucose testing.
• Records study data, samples, and/or results in various databases; maintains databases for subjects and subject scheduling; performs data validation checks and pursues resolutions to erroneous data; produces various reports in response to requests from PI, sub-investigators, and/or other study stakeholders.
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Resolves patient care issues.
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Participates in study-specific and CRC training.
• Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed.
• May provide guidance and/or support to less experienced clinical research staff.
• Processes samples in the CRC sample processing laboratory.
• Sets priorities for sample processing.
• Maintains specimen tracking and data entry for sample processing.

General Responsibilities

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.