Research Specialist II

Job Title

Research Specialist II

Agency

Texas A&M University - Corpus Christi

Department

Research and Innovation

Proposed Minimum Salary

Commensurate

Job Location

Corpus Christi, Texas

Job Type

Staff

Description:

• 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.

Responsibilities:

• 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,

• 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 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.

 

Qualifications:

• 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) 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.

• 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 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).

 

Preferred Qualifications:

• 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

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