Coordinator, Clinical Studies

Coordinator, Clinical Studies

Job Responsibilities

Clinical Trial Management

• Reads protocol and develop systems for screening and scheduling patients. Develops documentation templates and other tools as needed for clinical trial management.
• Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires ability to gather relevant information and determine the appropriate information to report.
• Responsible for tracking return visit time points including deviations, violations, and or adverse eventsper protocol and recording.
• Knowledge of protocol databases and tools: internal databases such as CORe, ePRTCL, or Prometheus. External databases per sponsor such as RAVE. General computer skills such as Microsoft office and others as designated.
• Collaborates with other members of the multidisciplinary team (research nurses, lab staff, and clinic personnel) as necessary.
• Coordinates routine monitoring with sponsors representative or clinical research organizations. Provides sufficient, appropriate, and timely responses to sponsors and or PI.
• Conducts routine monitoring per departmental quality assurance Standard Operating Procedures (SOP) for assigned clinical trials.
• Ongoing assessment of quality assurance for assigned clinical trials to ensure quality data.
• Communicates with the PI, research nurse and other trial team members regarding upcoming deadlines, research and protocol meetings, and other pertinent information.

Administrative Research Functions:

• In consultation with the research nurse and PI, completes and submits Continuing Reviews, Investigational New Drug (IND) reports, sponsor and other required reports in a timely manner.
• Participates in protocol start up meetings and close-out visits.
• Participates in the development of policies, procedures, and work flow processes to ensure project efficiency and effectiveness.
• Responsible for generating reports from databases for pertinent other reports.
• Advocate for the clinical research process per departmental, local and federal regulations in keeping with Code of Federal Regulations and Good Clinical Practice.

Routine Administrative Functions:

• Demonstrates proactive and effective 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.
• Must be able to independently initiate weekly assignments without supervision. Able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. Have excellent verbal and written communication skills.
• Other duties as assigned

Education Required: Bachelor's degree.

Experience Required: 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