The Sr. Clinical Studies Coordinator - Trial Oversight is responsible for the overall performance of assigned trials. The team member acts as the Primary Investigators (PI) partner on the trial, becoming their go to source for all information related to the execution and maintenance of the trial. This partnership includes the timely QA of all aspects of the trial. In addition, the team member holds pre-SIV/pre-activation meetings to ensure protocol preparedness for the study team as a whole, runs monthly PI oversight meetings and guarantees all regulatory documentation for the trial is maintained in an accurate and current state. The team member is the primary point of contact for the Sponsor of the trial and ensures that all queries, reports and data locks are met.
In addition to the above summary of duties, the Senior Clinical Studies Coordinator- Trial Oversight is responsible for ensuring that ongoing training is maintained, new processes implemented are enforced and all training is documented across team members. This role safeguards from inconsistent practice and execution of assigned duties.
As a team lead, provides mentorship and training for team members: an education and training element within the department (30%):
- 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 protocols and compliance informational
- Communicates with the PI, research nurse and others regarding upcoming deadlines, research and protocol meetings, and other pertinent information.
- Assists with the hiring, development, and evaluation process of research data management staff.
- Coordinates schedules for monitor visits and monthly PI meetings.
- Develops and maintains staff orientation and training resources.
- Completes initial and ongoing staff orientation/training and acts as lead preceptor for all research data management staff.
- Assesses the effectiveness of training programs, identifies learning needs, and modifies training processes as needed.
- Develops, implements and maintains templates for team members to increase clinical trial management effectiveness.
Designs, implements, monitors, and reports on clinical research project status, ensuring on-time performance (20%):
- Reads protocol and helps develops systems for screening and scheduling patients. Develops on-study notes and other documents as needed for protocols 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 protocol, tracing and recording.
- Responsible for tracking and recording deviations, violations, adverse events and other study related activities.
- Knowledge of protocol databases and tools: CRF, CORe, GURU, Microsoft office, Excel, and others as designated.
- Consults with PI and the Research Nurse Supervisor (RNS) regarding ongoing study assignments. Collaborates with other members of the multidisciplinary team (research nurses, lab staff, and clinic personnel) as necessary.
- Works with PI and fellow team members to develop recommendations on amendments to the protocol that will improve protocol execution.
- Ensure all required regulatory documentation for the trial is completed and stored per department policy.
Assists in analysis and quality assurance of clinical research information (20%)
Assists with Administrative Research Functions (10%):
- Coordinates routine monitoring and audits with industry sponsor pharmaceutical representative or clinical research organizations. Provides sufficient, appropriate, and timely responses to sponsor, MDACC IND and written queries.
- Assists with training staff for MDACC IND studies to consist of generating reports from databases for pertinent reports
- In conjunction with the Supervisor Clinical Studies, conducts routine monitoring per departmental quality assurance Standard Operating Procedures (SOP) for multicenter studies when GU Medical Oncology is the lead institution.
- Will perform quality assurance on Non Investigator Initiated Trials to ensure quality data.
- 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.
Communicates in a manner that fosters a positive, productive environment (20%):
- 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.
- He/she must be able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. He/she must have excellent verbal and written communication skills.
- Advocate for the clinical research process per institutional, divisional, and departmental SOPs in keeping with Good Clinical Practice for research.
- Other duties as assigned.
ADDITIONAL CLINICAL TRIAL MANAGEMENT DUTIES
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE:
- Consults with principal investigators (PI) regarding ongoing clinical trial assignments depending on protocol complexity and priority.
- Requires ability to gather relevant information and determine the appropriate information to report regardless of trial specifics.
- Depending on trial priority, communicates with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, and other events related to data.
- Schedules and participates in monthly PI meetings. Provides sufficient, appropriate, and timely responses to PI queries related to a study.
- Assist primary Trial Oversight with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.
- Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.
- Assists new/current team members in properly assimilating pertinent information in order to compose written correspondence. A skill highly regarded as the most effective and primary communication for Trial Oversight.
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
exempt and not eligible for overtime pay
US Dollar (USD) 59,600
US Dollar (USD) 74,500
Maximum Salary :
US Dollar (USD) 89,400