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Senior Coordinator, Research DataJOB SPECIFIC COMPETENCIESCoordinate protocol submission and regulatory correspondence for assigned departmental laboratory research studies under direct guidance from Regulatory Administration Supervisor.-Coordinate and prepare the regulatory flow of paperwork and associated correspondence for assigned departmental laboratory studies.-Communicate verbally and in writing, as needed or as requested by study investigator and regulatory supervisor with internal reviewers (e.g. Institutional IRB) or external agencies-Coordinate preparation and submission of annual IRB status reports for laboratory protocols in compliance with established institutional deadlines.-Meet regulatory with the Regulatory Supervisor to discuss current status of projects and to maintain a consistent dialog and united focus.-Anticipate and meet deadlines for laboratory submissions and processingAdministrative support for Thoracic/Head & Neck Medical Oncology Clinical Protocol Administration area and Regulatory Administration Supervisor.-Responsible for preparation and submission of assigned regulatory documentation (CVs, medical licenses, Form 1572, Financial Disclosures, Signature Pages, Delegation of Authority, etc.) to industry sponsors in compliance with institutional, state, and/or federal regulations for study initiation, conduct, and termination.-Assist regulatory coordinators with initial electronic protocol submission start-up procedures and ongoing compliance of the site regulatory files to ensure up-to-date information is consistently available prior to routine monitoring visits, federal and institutional audits, etc.-Physically hand carry paperwork through the institutional system for timely completion, which includes, but is not limited to, carrying protocols from one office to another to deliver, obtain signatures, etc.-Other projects as assigned.Administrative coordination of established tracking systems for Thoracic/Head & Neck Medical Oncology Clinical Protocol Administration Activities-Maintain internal tracking notification systems to clinical research team (Regulatory Administration, Research Nursing, and Data Management) to ensure timely submission and preparation of departmental clinical protocol and laboratory annual reviews in compliance with expected institutional deadlines.-Maintain tracking and internal notification schedule for institutional CVs, medical licenses, laboratory certifications, and investigator research training certifications.-Attend weekly meetings of the regulatory staff to discuss current status of projects and to maintain a consistent dialog and united focus.-Prepare and submit timely submission of Internal and External Serious Adverse Event reports as needed.-Ensure forms are completed, signed, and dated appropriately by research nurse and principal investigator.-Submit to IRB and IND Office-Maintain SAE tracking tool to assess departmental compliance with institutional submission guidelines and record all submissions to the IRB-Determines appropriate IND Safety Letter submission procedures by evaluating sponsor IND safety notifications against Departmental Guidance for Investigational Agent Risk Profiles Utilized by M.D. Anderson Institutional Review Board (under supervision of Principal Investigator)Secretarial support for Regulatory Administration Supervisor, Assoc. Director Research Planning and Development, and Department Administrator-Compose simple correspondence and route appropriately.-Correctly complete and route departmental and institutional forms.-Make photocopies as assigned.∙Schedule meetings and complete all related details, including obtaining equipment, making conference room reservations, and completing catering requests.-Provide regular progress reports of assigned projects.-Other duties as assigned.Other duties as assignedHigh school diploma or equivalent. Preferred Education: Bachelor's degree Four years of related experience. With preferred degree, no experience required. 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.htmlAdditional Information
Requisition ID: 157088
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 39,500
Midpoint Salary: US Dollar (USD) 49,500
Maximum Salary : US Dollar (USD) 59,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: No
