Senior Coordinator, Clinical Studies

Senior Coordinator, Clinical Studies

Responsibilities

PROFESSIONAL EXPERTISE AND MENTORING (30%)

• Participates in the mentorship and training of team members.
• Trains and/or orients Coordinators of Research Data, Sr. Research Data Coordinators, Research Data Specialist and Research Nurses to the department and to clinical research procedures/processes.
• Serves as a resource for research personnel regarding clinical trials and compliance information.
• Plans and conducts professional and ancillary education sessions to ensure dissemination of new information and policies.
• Attends research related departmental meetings and institutional continuing education programs
• 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.

CLINICAL TRIAL MANAGEMENT (40%)

• Participates in pre-activation, startup, and close out for assigned trials.
• Independently designs, implements, monitors, and reports on clinical research project status, ensuring on-time performance. Communicates upcoming deadlines, such as data locks, reports, annual reviews meetings, and other pertinent information as scheduled.
• Reviews clinical trial and helps to develop systems for screening and scheduling patients. Develops documentation study notes and other documents as needed with patient care team members.

· Responsible for accurate and timely transcription of study data to trial 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 per clinical trial, tracing and recording.

· Responsible for tracking and recording deviations, violations, adverse events and other trial related activities.

· Provides sufficient, appropriate, and timely responses to sponsors written queries.

· Knowledge of clinical trial and institutional databases or tools such as: CORe, GURU, Prometheus, ePRTCL, Microsoft office, Excel, and others as designated.

· Consults with PI and the Research Nurse Supervisor regarding ongoing study assignments. Collaborates with other members of the multidisciplinary team (research nurses, lab staff, and clinic personnel) regarding amendments or process adjustments during the life of the trial.

· Ensures regulatory documentation is completed and stored per department policy in conjunction with the regulatory coordinator. .

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ADMINISTRATIVE (30%)

• Coordinates routine monitoring and audits with industry sponsor pharmaceutical representative or clinical research organizations.
• Generates reports from databases for required reviews.
• In conjunction with the Supervisor Clinical Studies, conducts routine monitoring of data entry independently or with the Quality Assurance Specialist in order to assess regulatory compliance.

· Participates in clinical trial pre-activation, startup meetings and close-out visits in order to assess workloads with the Supervisors, Managers, and Director.

· Participates in the development of policies, procedures, and work flow processes to ensure project efficiency and effectiveness.
In conjunction with the Supervisor Clinical Studies reviews templates, reports and data for Coordinator Clinical Studies Trial Oversight team members. Provides constructive feedback in order to improve staff knowledge and regulatory compliance.
Education Required: Bachelor's degree.

Experience Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. 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.

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