Clinical Research Specialist

Department

CTSI CLINICAL RESEARCH SERVICE (IN-PCIR-IUINA)

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.

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION

Required

• Bachelor's degree in science or a health-related field and 1 year of health-related or research experience. OR
• Associate's degree in an allied health profession and 3 years of health-related or research experience.

Preferred

• Research experience

LICENSE AND CERTIFICATES

Preferred

• Medical Assistant Certification

SKILLS

Required

• Proficient communication skills.
• Maintains a high degree of professionalism.
• Demonstrates time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast paced, dynamic environment.
• Highly thorough and dependable.
• Possesses a high degree of initiative.
• Ability to build strong customer relationships.

Preferred

• Software systems, such as Microsoft Word and Excel, BUY.IU, Oracle, Cerner, Teletracking, Jabber, Diagnotes.
• Must be knowledgeable about protocol and study visit requirements to ensure study visit is scheduled appropriately.
• Kowledge and ability to use Electrocardiogram, Thermometer, Dynamap, Manual Blood Pressure, Stadiometer, Scale, Computer, Copier/Printer/Scanner/Fax, Centrifuge, Pipette, Refrigerator, and Freezer (-20 and -80).

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

Indianapolis, Indiana

Work Hours

7:00 PM-7:00 AM

36 hours per week

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Job Classification

Career Level: Mastery

FLSA: Nonexempt

Job Function: Research

Job Family: Clinical Research

Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.

If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.

Contact Us

Request Support
Telephone: 812-856-1234