MD Anderson Cancer Center Supervisor, Clinical Studies - Melanoma Medical Oncology in Houston, Texas
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 Clinical Studies Supervisor position impacts research protocols and the patients enrolled in designated protocols.
The salary range is: min-$68,800, mid-$86,000 and max-$103,200.
•Provides overall coordination and facilitation of Melanoma Medical Oncology (MMO) Clinical Studies Coordinator management.
•Together with departmental leadership and nursing management, facilitate the development of the Clinical Studies Coordinator role for the MMO Research Program.
•Supervises the training, development and evaluation process of the Clinical Studies Coordinator staff.
•Coordinates schedules, assignments, and approves leave requests for Clinical Studies Coordinator staff.
•Assures that policies/procedures of the institution and department are communicated to staff formally and informally by written and/or verbal means.
•Develops and maintains orientation process. Conducts initial staff orientation and monitors staff development for all Clinical Studies Coordinator staff. Assesses the effectiveness of training programs, identifies learning needs, and modifies orientation process as needed.
•Creates and maintains policies relating to staff development. Monitors adherence to policies and maintains development files for Clinical Studies Coordinator staff.
•Shares information and, as requested from the Associate Director, Research Planning and Development, develops educational presentations as required or needed.
•Works collaboratively with the management team to evaluate protocols for feasibility. Participates in start-up activities to ensure timely startup of new trials.
•Assists with the development of Clinical Studies Coordinator management tools and training modules for multicenter protocols as needed when MMO is the lead institution. Participates in site initiation visits and teleconferences to enhance multicenter research activities.
•Assists in the review of amendments of protocols and facilitates operational changes together with the management team as appropriate.
•Maintains accurate protocol assignment and oversees the execution of all Clinical Studies Coordinator Group reports of accrual/protocol management activities.
•In collaboration with the clinical research group management, reviews current departmental clinical research policies and processes to ensure relevance. Modifies and/ or develops new guidelines as requested.
•Consults with Associate Director, Research Planning and Development and Research Nurse Manager regarding ongoing clinical trial assignments.
CLINICAL TRIAL MANAGEMENT
•In consultation with the physician/PI, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols.
•Reads protocol and in collaboration with the PI, develops systems for screening patients. Assists with the development of source document templates and other documents as needed for protocols.
•In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately.
•Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, database issues, protocol status, and other events
•Assists with internal quality assurance audits of clinical research group processes related to Clinical Studies Coordinator management and the adherence to relevant departmental policies.
•Works closely with PI to ensure consistency with source documentation; includes generating written queries for missing/deficient source documentation. As needed, obtains patient charts and outside documents required for protocol compliance
•Participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.
•Assists with the collection and evaluation of data, and other protocol-specific clinical tasks as needed.
REPORTING AND TEAM BUILDING
•Attendance at relevant meetings and conferences as needed. Shares information via written reports and/or presentations to research and/or other management team colleagues.
•Collection and development of criteria information for protocol submission, and creation of Standard Operating Procedures (SOPs) for protocol production as required by the department.
•Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, audits, conferences, posters, and manuscripts as required by the department.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE
•Attends appropriate departmental meetings and institutional continuing education programs
•Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.
•Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
•Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
•Other duties as assigned.
Required: Bachelor's degree.
Preferred: Master's degree.
Required: Six years experience with research studies or direct patient care obtained from nursing, data gathering or related field to include three years in a lead or supervisory capacity. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience and three years of supervisory 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
Employee Status: Regular
Minimum Salary: US Dollar (USD) 68,800
Midpoint Salary: US Dollar (USD) 86,000
Maximum Salary : US Dollar (USD) 103,200