JOB SPECIFIC COMPETENCIES
Coordination, development, and administration of departmental investigator-initiated clinical research protocols and multidisciplinary clinical trials and assistance with other clinical research protocols. •Coordinate the submission of new protocols, the revision of existing protocols, and edit informed consent forms to be protocol-specific.
•Maintain and provide enhancements/improvements to a database of departmental clinical protocols
•Maintain and improve the protocol reference file system as an effective means of maintaining, storing, retrieving, and accessing up-to-date protocols, correspondence, etc.
•Supervise the collection of data and assist in the preparation of scheduled status reports describing interim data, using the Patient Data Management System (PDMS)
•Prepare and submit timely Serious Adverse Event reports to the IRB
•Supervise and assist with protocol annual review process and IND/IDE status reports by providing response and toxicity information on assigned protocols
•Assist clinical monitors to find study-related information
•Coordinate site initiation visits for all new industry-sponsored clinical trials
Coordination of regulatory correspondence on all departmental clinical research studies. •Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee, IRB) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration)
•Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination
•Coordinate and send outgoing material and correspondence to institutional, state, and/or federal agencies
•Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually for NCI studies)
•Inform sponsors and collaborators of regulatory status of protocols at least monthly in formal departmental protocol review meetings
Utilization of technical writing ability to compose and abstract medical and scientific information for preparation of written correspondence, reports, and protocols under the direction of study investigators. •Edit and/or write sections of protocols, grants, and reports as directed by study investigator(s) (e.g., preparing protocol abstracts, informed consent forms, and other sections as indicated).
•May be asked to review manuscripts before submission to publishing companies.
•Prepare specific protocol reports and analysis to assist in the preparation of manuscripts and grants.
•Provide summaries regarding the progress, goals, and objectives of clinical research studies for annual reports and/or final reports.
Coordination of protocol submissions to meet institutional protocol deadlines and other departmental paperwork deadlines. •Anticipate and meet deadlines for protocol processing
•Prompt staff to anticipate and meet deadlines for protocol processing
•May be required to physically hand carry paperwork through the institutional system for timely completion, which includes, but is not limited to, carrying grants and protocols from one office to another to deliver, obtain signatures, etc.
Coordination of weekly and ad hoc research meetings and research deadlines. •Coordinate research meetings under the guidance of a faculty member and coordinate with assigned secretarial support all related details, including obtaining equipment, making conference room reservations, and inviting appropriate speakers and collaborators
•Generate documents on computer, using word processing, spreadsheet, and other software to produce documents with at professional appearance and high degree of grammatical and spelling accuracy
•Coordinate and prepare a monthly protocol update for departmental review
•Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
Other duties as assigned
Bachelor's degree. Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience. 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