The Clinical Studies Coordinator collaborates with the research team and principal investigator in managing research protocols, assuring protocol compliance, quality assurance and communicating with staff regarding protocol information. Key Functions Designs, implements, monitors, and reports on clinical research project status, ensuring on-time performance:
* In consultation with the physician, assesses patients for eligibility through personal interviews and medical record review and assists in obtaining consents
* Reads protocol and develops systems for screening and coordinate scheduling patients per study visits
* Responsible for accurate and successful patient recruitment to assigned protocols Develops on-study notes and other documents as needed for protocols:
* Responsible for accurate and timely dictation of study notes in the institution's patient electronic medical record, 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 scheduling labs, 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, Prometheus, GURU, Microsoft office, Excel, and others as designated.
* Consults with PI and the Research Nurse Manager regarding ongoing study assignments. Collaborates with other members of the multidisciplinary team (research nurses, lab staff, and clinic personnel) as necessary. Assists in analysis and quality assurance of clinical research information:
* Assists in coordinating 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 and sponsored studies
* Assists in providing pertinent information for quality assurance on Non Investigator Initiated Trials to ensure quality data. Provides support and leadership for research staff peers: an education and training element within the department:
* Preceptor to other research team members
* Serves as a resource for research personnel regarding protocols and compliance informational
* Communicates with the PI, protocol lead research nurse/CSC and others regarding upcoming deadlines, research and protocol meetings, and other pertinent information. Assists with Administrative Research Functions:
* Participates in the submission process of Continuing Reviews in consultation with the trial manager, and PI for 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:
* 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. EDUCATION:
Required: Bachelor's degree.
Preferred: Master'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
Additional Information
Requisition ID: 167156 Employment Status: Full-Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 55,500 Midpoint Salary: US Dollar (USD) 69,500 Maximum Salary : US Dollar (USD) 83,500 FLSA: non-exempt and eligible for overtime pay Fund Type: Soft Work Location: Hybrid Onsite/Remote Pivotal Position: No Referral Bonus Available?: No Relocation Assistance Available?: No Science Jobs: Yes #LI-Hybrid
