Coordination of study initiation and operations of clinical research protocols

Assumes responsibility for the effective operation of research protocols in collaboration with the principal investigator, study sponsor and protocol administration team.

· Collaborates with multidisciplinary team as necessary to document patient care, achieve objectives of protocols, and maintain patient safety; instruct co-workers in allied fields in procedures for recording patient information per protocol.

· Prepares orders for protocol-related tests, procedures, consults; participates in development of protocol-specific treatment plans.

· Develops research documents and tools to aid in successfully meeting clinical trial requirements.

· Notifies clinical and/or research laboratories of protocol-required laboratory tests including EKGs, PKs, PDs, urine collection, etc. Prepares and presents protocol-specific training to ancillary staff (e.g. CTRC in-service) as needed.

· Attends protocol start-up meetings. Identifies protocol design problems. Collaborates with physicians and/or protocol sponsors regarding protocol design, development (including budget concerns) implementation, and evaluation; and assists to collect and develop critical information for protocol submission and revisions.

Communicates availability of protocol treatments for accrual.

· Acts as the point of contact for all external and internal agencies. Leads patient-update calls with sponsor; if required for multi-center trials, maintains contact with other participating institutions and coordinates all data pertaining to such studies.

· Knowledge of protocol databases and electronic applications; participates in maintaining data and activities to ensure preparedness for industry, institutional, and federal clinical trial audits.

· Utilizes the OneConnect system to make sure research charges are documented appropriately and that billing to sponsored study accounts is accurate. Ensure completion of monthly departmental reconciliation process for patient care charges on time.

Direct support for patient education, management & clinical trial activities

Identifies patient and family educational needs regarding treatment management, evaluation and follow-up in clinical trials through talking with patients person-to-person or by telephone and provides appropriate education and/or educational materials.

· Acts as liaison with patients, physicians and other research staff in providing administrative and patient care services for the coordination of assigned research protocols (e.g., chemotherapy, immunotherapy, targeted and/or cell therapy trials).

· Assesses patients and verifies protocol eligibility through personal interviews and/or medical record review. Provides feedback to physicians and multidisciplinary team regarding required screening activities and scheduling time constraints. Schedules patient tests, keeps patients informed about test results and studies.

· In collaboration with the Principal Investigator (PI), responsible for ensuring the informed consent is understood, signed and processed appropriately. Addresses research participants' inquiries and concerns.

· On a real-time basis, assesses the patient's clinical status; coordinates, evaluates and follows the patient's participation in clinical trials; provides nursing assessment and assists in management of toxicities and/or adverse events that patients may experience while on department clinical trials.

· Communicates determination of dose delays and dose reductions based on protocol criteria to treatment team. Collaborates with the entire medical care team as necessary.

· Documents and oversees study-related data in the patient's medical record, protocol-specific documents, and institutional reports as required.

· Maintains expert knowledge of adverse events and policies regarding reporting; coordinates FDA documentation including collecting, de-identifying, and submitting serious adverse event documentation to protocol sponsor and oversight groups such as the Investigational New Drug Office or Clinical Research Organization.

· Monitors the retrieval of protocol-related data as documented in the medical record and ensures accurate entry into protocol-specified databases and/or case report forms. As needed, obtains patient charts and outside records required for protocol compliance.

· Prepares and reviews necessary data for monitoring visits, audits, and safety summaries; generates protocol summary reports, and user-generated data reports as requested; compiles protocol and other data for manuscript submissions, as requested.

Ensures human subjects protection in accordance with federal, state and institutional requirements.

Professionalism, training and mentoring

· Demonstrates excellent oral and written communication skills when contacting patients, physicians, other institutions 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. Responds in a timely manner to queries, data entry, database issues, protocol status, and other events.

· Understands and adheres to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at training meetings; attends appropriate departmental meetings and institutional continuing education programs.

· Proficient in the use of Microsoft office applications and departmental electronic data systems;

· Under the direction of the Research Nurse Manager and/or Supervisors, the Sr. Research Nurse will aid in mentoring, training, and development of new research team members (transfers and new hires); assess the effectiveness of training programs, identify learning needs, and propose modifications to the orientation process as needed. Counsels employees with regards to problems encountered in daily operations.

· Assists in identifying deficient areas of the program and communicates these deficiencies along with potential resolutions to the research nurse manager and/or supervisor.

· Serves as a resource to team members and guides team in the absence of the Research Nurse Manager and/or supervisor.

· Participates in professional activities beyond the departmental level.

· Proactively seeks out educational opportunities and shares knowledge learned with the research team; keeps current concerning oncology and research study management issues through reading and/or attending meetings/in-services.

· Proposes and implements new process improvement projects, SOPs or guidelines that will increase the efficiency, quality and/or patient experience for clinical research studies and operations.

· Monitors accuracy compliance by research nurses, study coordinators and data coordinators by performing quality assurance (QA) audits.

Other responsibilities as assigned.

Education

Graduation from an accredited school of professional nursing.

Experience

Two years of registered nurse experience. Current State of Texas Professional Nursing License (RN).

Certification/Licensure

Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) certification. Preferred: American Heart Association Basic Life Support (BLS), ACLS (Advanced Cardiac Life Support) or PALS (Pediatric Advanced Life Support) certification as required by patient care area.

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: 167395

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Days

• Minimum Salary: US Dollar (USD) 76,500

• Midpoint Salary: US Dollar (USD) 101,200

• Maximum Salary : US Dollar (USD) 126,000

• FLSA: exempt and not eligible for overtime pay

• Fund Type: Soft

• Work Location: Hybrid Onsite/Remote

• Pivotal Position: Yes

• Referral Bonus Available?: Yes

• Relocation Assistance Available?: Yes

• Science Jobs: No

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