PSYCHIATRY (IN-PSYC-IUINA)
The BRANCH Lab, led by Dr. Rachel Gunn, conducts clinical research focused broadly on substance use, mental health, and behavioral outcomes. The lab has 2 ongoing clinical research studies: the National Evaluation of Substance Use in Transition to Pregnancy (NEST) study and the Longitudinal Investigation of Clinical Outcomes (LINC) study. Project NEST is a National Institute on Drug Abuse (NIDA) funded longitudinal project focused on substance use and health during the perinatal period. Project LINC, is a National Institute on Alcohol Abuse and Alcoholism (NIAAA) funded longitudinal study investigating the impact of cannabis use on alcohol treatment outcomes.
The Clinical Research Assistant contributes to the implementation of study protocols, participant-facing research procedures, data collection (both in-person and virtually), and study management. This position works closely with the Principal Investigator (PI) and under the training and supervision of the Clinical Research Coordinator, the Clinical Research Assistant assists with multiple phases of clinical research.
Department-Specific Responsibilities
- Supports 2 ongoing clinical research studies examining substance use and health outcomes
- Works flexibly between studies in the lab
- Virtually recruits and screens potential participants according to study eligibility criteria and approved recruitment procedures
- Conducts participant outreach and follow-up through phone, email, and other approved methods
- Assists with enrollment and informed consent procedures following Institutional Review Board (IRB) approved protocols
- Conducts and supports study visits, both in-person and virtually, and other participant-facing research procedures
- Administers research questionnaires, assessments, and other study measures following standardized protocols
- Maintains accurate and timely study documentation and enters research data into study databases
- Assists with participant tracking, scheduling, retention, and follow-up throughout the longitudinal study
- Monitors study materials and maintains organized research records
- Follows all study protocols, institutional policies, and human subjects' research requirements
- Communicates regularly with study team members regarding recruitment, participant follow-up, data collection, and study progress
- Assists with data quality checks, preparation of study materials, and other research-related tasks
- Contributes to the overall functioning of the lab and supports other research activities as needed
- Directs clinic recruitment, including partnering with alcohol treatment centers, conducting on-site recruitment, liaising with clinical staff, and confirming eligibility criteria
- Facilitates the collection and secure transmission of Health Insurance Portability and Accountability Act (HIPAA) forms to treatment centers to verify treatment status
- Works within a collaborative environment alongside clinical research coordinators, students, and other researchers
General Responsibilities
- Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures
- Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol; performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals; collects patient consent and authorization for treatment intervention documents and performs those interventions as needed
- Conducts routine experiments and/or coordinates research study procedures in accordance with Standard Operating Procedures (SOPs); receives, collects, and records study data in database; communicates and keeps researchers and/or PI up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures
- Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families
- Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits
- Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments
- Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription)
- Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings
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.
Required
EDUCATION / WORK EXPERIENCE
- High school diploma or equivalent (such as HSED or GED) plus 5 years patient-related or research experience that includes 2 years of experience with clinical studies; OR
- Associate's degree in allied health profession plus 1 year of patient-related or research experience; OR
- Bachelor's degree in any field or 3 years of college-level science plus 2 years of patient-related or research experience; OR
- Bachelor's degree in science or health-related field
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
Preferred
- Comfortable working with research participants and discussing substance use and mental health
- Attention to detail
- Dependable
- Ability to manage responsibilities across multiple projects
- Ability to work collaboratively and communicate effectively with participants and research team members
- Ability to work and track hours
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.
This position requires travel within 40 miles to meet participants for the drop off and pick up of study materials.
This position is ideal for a curious, motivated, and highly organized individual who is interested in gaining broad experience in clinical substance use research and is ideally suited for individuals seeking to launch or further develop a career in clinical research, including those considering graduate, medical, or other health-related professional training.
This position offers hands-on experience with clinical research across 2 complementary studies and exposure to research involving perinatal substance use, alcohol and cannabis use, and health and behavioral outcomes, providing the applicant with the opportunity to gain experience across distinct clinical research projects and populations.
Flexible hours, including weekends and evenings, as needed for study procedures
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 & 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.
Career Level: Intermediate
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research
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.
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