The primary purpose of the Clinical Research Monitor position is to conduct education, evaluation and review of clinical trial conduct to ensure research and scientific integrity relating to human subject research and compliance with institutional policies, federal regulations, and Guidelines to Good Clinical Practice for clinical research trials.

　　KEY FUNCTIONS

　　Develops and maintains highly collaborative working relationships with internal teams, investigators and study staff. Participates in the development of and/or review of study related documents (Protocol, Informed Consent, CRFs, Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).

　　For MD Anderson Sponsored trials, represents the sponsor (MD Anderson), in study initiation activities, ongoing protocol visits, and study closeout activities. Conducts site initiation visits (SIV). Oversees the management of monitoring visit schedules and ensures timely completion of monitoring activities and creates reports summarizing relevant findings from monitoring visits.

　　Assess the conduct of clinical trials by monitoring compliance with the protocol, federal regulations and ICH guidelines as applicable, and to ensure safety of human subjects, research related evaluations and tests are conducted in accordance with the protocol and regulatory requirements and compliance with regulatory agency requirements and institutional policies relating to human subject research.

　　Initiates actions necessary with principal investigators and research teams to correct potential issues identified during monitoring visit, schedule meetings with team to discuss issues concerning scientific integrity and document the findings and action plans. Escalates study issues to Senior Management and Principal Investigator in a timely manner. Notifies investigators of any safety or human subject's protection related findings in a timely manner.

　　Attends and coordinates project meetings and/or training as required. Assists in preparing sites for audits or inspections and assists with audit responses. Reports study activities to Senior Management to ensure project milestones and timelines are maintained.

　　EDUCATION

　　Required:

　　Bachelor degree in healthcare admin, nursing or related field.

　　Preferred:

　　Preferred: Bachelor of Science in Nursing.

　　EXPERIENCE

　　Required:

　　Four years clinical experience, to include two years of clinical research.

　　OTHER

　　Required:

　　Must pass pre-employment test as required and administered by Human Resources.

　　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

　　Additional Information

　　Requisition ID: 165007

　　Employment Status: Full-Time

　　Employee Status: Regular

　　Work Week: Days

　　Minimum Salary: US Dollar (USD) 86,000

　　Midpoint Salary: US Dollar (USD) 107,500

　　Maximum Salary : US Dollar (USD) 129,000

　　FLSA: exempt and not eligible for overtime pay

　　Fund Type: Hard

　　Work Location: Remote

　　Pivotal Position: No

　　Referral Bonus Available?: No

　　Relocation Assistance Available?: No

　　Science Jobs: No

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