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 assigned studies.
Coordinate assigned human subjects studies by a supervising Principal Investigation (PI) in accordance with DHHS, FDA, GCP, and protocol guidelines
Research study setup
Drafting initial submissions
Ensuring research does not commence before initial approval
Managing annual review deadlines and submitting annual review submissions
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 protocol expiration
Submitting amendments to research regulatory committees and ensuring changes are not implemented until approval is received
Managing research team compliance with training requirements
Managing studies to ensure protocol compliance,
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 report forms.
Complete verification of subjects consent prior to beginning study procedures.
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 required.
Identify potential problems and inconsistencies in protocol adherence and study records and take actions as appropriate.
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 inspection readiness.
Working with the IRB to complete corrective actions from study audits.
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) guidelines.
Knowledge of research/medical terminology and research practices.
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.
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 results.
Ability to interpret research committee requirements and needs; and convert into actions that will be effective to meet those requirements
Work independently in a fast-paced, often changing environment.
Team oriented problem solver who takes ownership of their work.
Relationship building: Ability to develop effective relationships to liaison effectively between researchers and the committee.
Language skills: Ability to read and interpret documents such as rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.
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 software.
Intermediate skills in Microsoft Office Suite (Word, Excel, and PowerPoint).
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 research methods
Preferred experience working in iRIS research compliance software program to submit research applications and manage submission approvals
Texas A&M University-Corpus Christi
6300 Ocean Dr.
Corpus Christi, TX 78412
Authorized to work in the US