Research Specialist II
- Employer
- Texas A&M University Corpus Christi
- Location
- Texas, United States
- Salary
- Salary Not specified
- Date posted
- Jun 28, 2022
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Level
- Administrative
- Employment Type
- Full Time
You need to sign in or create an account to save a job.
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
Job Description
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
- Drafting initial submissions
- 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,
- Managing continuing review deadlines
- 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.
- Perform subject recruitment in accordance with IRB-approved
protocol under supervision of study PI.
- 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.
- Managing research records (regulatory binders) of study
activity, including case report forms, research records, study
staff training compliance, and other regulatory forms
required.
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.
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- 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
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
jeid-eab90c9993a54d4caa84847a11031756
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert