MD Anderson Cancer Center Supervisor, Clinical Studies in Houston, Texas
The primary purpose of the Supervisor, Clinical Studies Coordinator position is to provide management and oversight of departmental clinical research activities, designated protocols and staff.
JOB SPECIFIC COMPETENCIES
Supervision and Training Responsible for managing duties and tasks of assigned personnel. Responsible for completing annual performance evaluations and employee professional development for assigned personnel. Participates in training and mentoring of assigned staff. Effectively conducts assigned operations of research protocols. Coordinates, evaluates and follows patient participation in protocols. Assists in the collection and evaluation of data. Under supervision of the medical staff and research nurse staff, performs protocol-specific tasks including screening, ordering tests, collecting specimens and study documentation of patient reported responses. Assists in initiating and conducting site initiations. Participates in the development of training programs and education of minimal risk staff and facilitates educational sessions for other support staff in study coordination. Provides guidance regarding study procedures to assist in protocol compliance. Collaborates with other departments to provide training for new staff and/or provide education tools/resources to train staff within that group.
Minimal Risk Studies Management Ensures that all laboratory, minimal risk research studies and/or trials involving patient electronic applications have appropriate coverage, including cross training of members on the team. Attends departmental meetings to provide current and updated information related to study management, compliance and staff related issues. Assigns protocols to staff and monitors protocol data entry. Collaborates with the regulatory team in revising and submitting protocol amendments, as well as provide clinical research finance information for budget related purposes. Works with the department finance team to review funding for staff, patient care costs and other research related charges. Assists in the creation of the BIMS templates and IR draw sheets for research related biopsies. Educates patients in the use of electronic applications associated with minimal risk studies.
Data Quality Assurance Works in collaboration with the Principal Investigators of minimal risk and treatment protocols to ensure that co-collection lab studies are coordinated and that the blood collection limits are within institutional research blood guidelines. Engages in regular research improvement activities. Uses performance and research outcome data for continuous quality/compliance improvement. Contributes to developing structure, processes and systems to improve the research workflow. Ensure deviations, CAPAs, and regulatory commitments are met and that the level of quality is maintained. May include independent investigation to resolve quality issues including recommendations to senior management for corrective and preventative actions to address issues effectively. Attends research team meetings, departmental meetings, mandatory training, and/or other events to remain current of policies and procedures related to data and protocol management. Provides input for completion of research analysis. Assists in the preparation of information and reports for manuscript/fund raising events as required. Collaborates with database administrator and statistician to create study specific requested reports. Assists in development and maintenance of systems for protocol data as appropriate.
Patient Consent Management Reviews patient eligibility of potential study cases and assists in obtaining consents. Follows patients on studies and maintains knowledge of adverse events. Submits information on adverse events to Research Nurse, PI or Research Nurse Manager. Tracks p rotocol related labs, responses and research tests. Enters data into case report forms. Maintains necessary data for audits. Schedules patient tests, keeps patients informed about test results and studies. Collaborates with physicians, mid-level practitioners, research nurses and data managers to document patient care. Collaborates with data manager to develop protocol specific data bases.
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 to include three years of lead or supervisory experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.
Must pass pre-employment skills 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
Requisition ID: 150081
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days
Fund Type: Soft
Work Location: Onsite
Pivotal Position: No
Minimum Salary: US Dollar (USD) 71,000
Midpoint Salary: US Dollar (USD) 89,000
Maximum Salary : US Dollar (USD) 107,000
Science Jobs: No