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Clinical Research Consent Writer - Clinical Trials Start-Up
Opportunity to join one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention.
The primary purpose of the Clinical Research Consent Writer is to edit all informed consent documents attached to clinical/PBHSR/laboratory protocols submitted by MD Anderson faculty to the Office of Human Subjects Protections to maintain compliance with federal regulations and ensure the protection of human research subjects. The Clinical Research Consent Writer is responsible for editing informed consent documents to a sixth- to eighth-grade reading level, while remaining faithful to the meaning intended by the Principal Investigator and in compliance with federal regulations. Reorganization of the variable sections of the consent document is required to improve clarity, consistency, flow, and readability.
The ideal candidate will have regulatory and editing experience, along with prior medical writing experience. Research certification preferred.
The hours for this position are Monday – Friday, 8am-5pm (Central Standard Time)
The Clinical Trials Start-up teams work with the departments to provide support for study submissions.
These teams review new protocol submissions for document verification, write or edit the informed consents, and provide ongoing support with the Protocol Navigation team through activation. In addition, these groups can perform start-up regulatory functions for clinical department and also manage submissions to Harris Health.
KEY FUNCTIONS
Informed Consent Editing (80%)
Edit of all informed consent documents attached to clinical/PBHSR/laboratory protocols submitted by MD Anderson faculty to the Human Subjects Protection using correct grammar and punctuation.
Activation Timelines (10%)
Improve study activation timelines by increasing cross training and collaboration amongst central offices and research departments to streamline processes and create efficiencies.
Data Integrity (10%)
Ensure OHSP data integrity by performing accurate and consistent data entry into the relevant databases in the electronic system based on applicable job functions.
Success will be measured through fewer than 20% of contingencies being based on missing federal data elements in informed consents submitted to the IRB.
MD Anderson offers our employees:
* Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week.
* Group Dental, Vision, Life, AD&D and Disability coverage.
* Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals.
* Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs.
* Tuition Assistance Program after six months of service.
* Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans.
* Employer paid life, AD&D and an illness-related reduced salary pay program.
* Extensive wellness, recognition, fitness, employee health programs and employee resource groups.
* Opportunities for professional growth through Career Development Center and Mentoring programs.
EDUCATION
Required:
Bachelor's degree in a related field.
EXPERIENCE
Required:
Two years of regulatory or editing experience.
Preferred:
Prior Experience in medical writing
CERTIFICATION
Preferred:
Research certification (CCRP, CCRC, RAP, CIP)
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
