Research Specialist II
Texas A&M University - Corpus Christi
Research and Innovation
Proposed Minimum Salary
Corpus Christi, Texas
- Under general supervision, the Senior Research Specialist is
responsible for managing human subjects study performance and
assisting the Study Principal Investigator in the regulatory
management of the research study. The Senior Research Specialist
plans, coordinates, evaluates, and manages the regulatory
compliance, subject enrollment and associated research data for
- Coordinate assigned human subjects studies by a supervising
Principal Investigation (PI) in accordance with DHHS, FDA, GCP, and
- Research study setup
- Drafting initial submissions
- Ensuring research does not commence before initial
- Managing annual review deadlines and submitting annual review
- Managing changes to the study, including drafting and
submitting amendments to the research protocol
- Maintain research approvals for IRB.
- Managing continuing review deadlines
- Submitting annual reviews with sufficient time to avoid
- Submitting amendments to research regulatory committees and
ensuring changes are not implemented until approval is
- Managing research team compliance with training
- Managing studies to ensure protocol compliance,
- Subject enrollment
- Perform subject recruitment in accordance with IRB-approved
protocol under supervision of study PI.
- Collect initial subject screening and demographic information
to support inclusion/exclusion determinations.
- Review documentation to determine subject protocol eligibility
under supervision of study PI.
- Maintain timely internal source documentation, as well as
sponsored required documentation, of subject enrollment and case
- Complete verification of subjects consent prior to beginning
- Ensure a flow of communication between subject, study staff,
recruitment team, sponsor, and auditors, if applicable.
- Assisting in maintaining study audit readiness
- Managing research records (regulatory binders) of study
activity, including case report forms, research records, study
staff training compliance, and other regulatory forms
- Identify potential problems and inconsistencies in protocol
adherence and study records and take actions as
- Submitting reportable events as required.
- Working with research compliance committee in scheduling
routine study audits, including regulatory binder and informed
consent document reviews.
- Provide support to PI in preparation to maintain a state of
- Working with the IRB to complete corrective actions from study
- Bachelor's degree
- Six (6) years related experience and/or training.
- Equivalent combination of education and experience in
conducting human research studies may be used as a substitution for
the minimum requirements.
- Experience working in research in a professional setting or
working in an academic research setting.
- Basic knowledge of human research projection requirements,
Understands regulatory requirements, as well as Good Clinical
Practices (GCP) and International Conference of Harmonization (ICH)
- Knowledge of research/medical terminology and research
- Familiar with Study Regulator Binders and maintaining record
keeping for research studies.
- Ability to managing multiple concurrent studies.
- Highly organized with excellent attention to detail.
- Ability to keep concise, accurate, and neat records for
federal, state, EH&S, USDA, FDA or other entities.
- Reasoning ability:
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Ability to interpret research data from various internal and
external sources; and to visualize and synthesize
- Ability to interpret research committee requirements and needs;
and convert into actions that will be effective to meet those
- Work independently in a fast-paced, often changing
- Team oriented problem solver who takes ownership of their
- Relationship building: Ability to develop effective
relationships to liaison effectively between researchers and the
- Language skills: Ability to read and interpret documents such
as rules, operating and maintenance instructions, and procedure
manuals. Ability to write routine reports and
- Communication skills: Strong interpersonal and communication
skills (oral and written), including the ability to articulate
complex issues to diverse audiences.
- Intermediate skills with Research Compliance Administration
- Intermediate skills in Microsoft Office Suite (Word, Excel, and
- Society for Clinical Research Associates (SoCRA) or Association
of Clinical Research Professionals (ACRP) certification required
following 2 years of employment
- Conducting social behavioral research and/or qualitative
- Preferred experience working in iRIS research compliance
software program to submit research applications and manage
All positions are security-sensitive. Applicants are subject to a
criminal history investigation, and employment is contingent upon
the institution's verification of credentials and/or other
information required by the institution's procedures, including the
completion of the criminal history check.
Equal Opportunity/Affirmative Action/Veterans/Disability Employer
committed to diversity.
To apply, visit https://tamus.wd1.myworkdayjobs.com/en-US/TAMUCC_External/job/Corpus-Christi-TAMUCC/Senior-Research-Specialist_R-050617