MD Anderson Cancer Center Coordinator, Clinical Research Program - Pre-Award/Budget in Houston, Texas
Coordinator, Clinical Research Program - Pre-Award/Budget
Location: United States, Texas, Houston, Houston (TX Med Ctr) at https://mdanderson.referrals.selectminds.com/jobs/12165/other-jobs-matching/location-only
Research at http://mdanderson.referrals.selectminds.com/landingpages/research-opportunities-at-md-anderson-cancer-center-14
Cancer Medicine 135100
Requisition #: 116189
The department of Melanoma Medical Oncology has the mission to develop better treatments for patients with melanoma by the alignment of laboratory and clinical approaches, provide outstanding care to patients with melanoma and train the next generation of clinical scientists capable of translating novel concepts from the laboratory to the clinic.
The primary purpose of the Coordinator, Clinical Research Program position is to provide administrative and patient care services for the coordination of research studies in the Department of GI Medical Oncology.
The salary range is: min-$50,800, mid-$63,500 and max-$76,200.
· Assists with strategic and long-range planning of departments’ clinical trials program. This includes coordination of weekly clinical research review meetings and also ad hoc meetings for department chair and faculty to review new protocols for potential participation.
· Collaboratively works with all department clinical faculty to provide support for clinical trials goals.
· Orients new faculty/support personnel on department’s clinical trials research infrastructure and procedures.
Administrative Management of Clinical Trials
· Manages administrative/regulatory aspects of research trials including federal and pharmaceutical funded protocols, through all components of a study.
· Work with study Principal Investigator (PI) by providing administrative support to develop, implement and complete research studies.
· Independently prepares protocol documents that comply with regulatory and institutional requirements.
· Works with study sponsors and/or Clinical Research Organizations (CROs)) to develop budget documents that conform to both MD Anderson and Sponsor requirements.
· Submits protocols to the Office of Protocol Research for Clinical Research Committee and IRB review.
· Responds on behalf of PI as appropriate to comments from protocol reviewers.
· Coordinates activities associated with site start-up and overall financial trial management.
· Assists PI as appropriate with preparation of responses to CRC and/or IRB.
· Acts as a liaison with private industry pharmaceutical companies to aid in the completion of ICD language appropriate for clinical trials.
· Ensures that all reviews are addressed to the satisfaction of the reviewers.
· Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for GIMO clinical trials. Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.
· Attends training classes concerning maintaining clinical trials documents according to departmental SOPs as well as Federal Regulations.
· Attends training classes concerning the research regulatory process and administrative management of clinical trials, including submissions to the CRC and IRB.
· Assists with creating presentations/ visual aids for adjunct staff concerning the regulatory aspect of clinical research trials administration.
· Assists with creating and presenting programs/in-services for faculty and staff related to the clinical research administrative process.
Maintenance of Integrity of Clinical Trials
· Develops and maintains a processing and tracking systems for protocol related paperwork.
· Processes budget and contract changes for protocol amendments.
Assurance of Accurate Information
· Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve these.
· Prepares and submits various reports to sponsors, investigators, regulatory authorities, and Manager, Clinical Protocol Administration and any others deemed necessary.
Compliance and Education
· Ensures compliance with Good Clinical Research Practice standards.
· Attends in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.
· Disseminates pertinent information to other team members. Participates in the development of departmental policies and procedures related to protocol research.
· Assists in the development of in-service educational events for GIMO team members.
· Maintains knowledge of clinical trials process
Required: Bachelor's degree in Nursing, Public Health, Healthcare Administration or related scientific field.
Preferred: Master's degree in Nursing, Public Health, Healthcare Administration or related scientific field.
Required: With Bachelor's degree, six years experience in area of research study obtained from nursing, data gathering or other related experience. With preferred degree, three years experience in area of research study obtained from nursing, data gathering or other related experience.
Preferred: Grants management 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