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Clinical Studies Coordinator, Investigational Cancer Therapeutics

MD Anderson

Houston, TX

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JOB DETAILS
SKILLS
Accidental Death and Dismemberment (AD&D), Administrative Skills, Adverse Events, Billing, Biotech and Pharmaceutical, Business Services, Cancer, Case Report Form (CRF), Clinical Assessment, Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Conferences, Contact Management, Corporate Funding, Cross-Functional, Data Analysis, Data Collection, Data Management, Database Administration, Database Programming, Disability Insurance, English Language, Federal Government, Funding, Government, Health Plan, Healthcare Providers, Infection Control, Informed Consent, Keyboards, Laboratory Analysis, Maintain Compliance, Medical Protocols, Medical Records, Medical Treatment, Microsoft Excel, Multitasking, Nursing, Organizational Skills, Outpatient Care, Pathology, Patient Assessment, Patient Care, Patient Follow-up, Patient Safety, Phase I Clinical Trials, Pivotal CRM, Presentation/Verbal Skills, Project/Program Management, Public Health, Radiography, Record Keeping, Regulations, Regulatory Compliance, Reporting Skills, Research Nursing, Research Protocols, Research Skills, Specimen Collection, Surveillance, Time Management, Willing to Travel, Writing Skills
LOCATION
Houston, TX
POSTED
30+ days ago
The primary purpose of the Clinical Studies Coordinator is to provide clinical evaluation, coordination, implementation, and monitoring of patients enrolled in phase I research protocols. Also serves as an effective point of contact regarding status and progress of phase I trials. Impacts clinical trials patients in designated protocols. Utilizes medical or clinical knowledge for supervised non-clinical patient interaction for the purposes of research data gathering and monitoring. Requires strict adherence to the policies and procedures of the institution.

The ideal candidate supports clinical trials by coordinating patient enrollment, monitoring protocol compliance, and managing research data. This role requires strong clinical research experience, excellent organizational skills, and the ability to manage multiple projects simultaneously while ensuring patient safety and regulatory compliance.

What We Offer?
* Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
* Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
* Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
* Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

Key Functions:
Coordination of activities related to initiation and conduct of clinical trials.
* Work with staff in Patient Business Services to develop research charge tickets for protocols.
* Interact with clinic staff to make sure research charge tickets are used appropriately and that billing to sponsored study accounts is accurate.
* Timely notification of patient on study to patient access coordinator and PBS.
* Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings. Identify and meet the educational, emotional, and psychosocial needs of patient and their families while on phase I clinical trials.
* Coordinate, evaluate, and follow the patient's participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of phase I trials, and maintain patient safety.
* Instruct co-workers in allied fields in procedures for recording patient information.
* Maintain data necessary for audits.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

Coordination of regulatory correspondence on clinical research studies.
* Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
* Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

Direct support to clinical trial research protocols.
* Review protocol documents including abstracts, text and informed consent for relevant information.
* Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in PDMS per protocol. Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse.
* Schedule patient tests; keep patients informed about test results and studies.
* Assist in obtaining consent for studies.
* Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
* Complete case report forms in a timely and accurate fashion.
* Assist in the screening for adverse events.
* Assist in modifying consents; submit to IRB.
* Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.
* Provide support for labor-intensive protocols as needed.
* Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.
* Act as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records.
* Obtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

Assist the primary investigator in collection and evaluation of data.
* Retrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.
* Generate CORE data reports, protocol summary reports, and user-generated data reports as requested.
* Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
* Additional projects, as assigned.

Collect or facilitate the collection of specimens as outlined in assigned protocols upon request.
* Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.
* Develop and maintain database for tracking specimens with high level of accuracy.
* Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

Other duties as assigned.

The performance for all expected outcomes is measured by observation by supervisor, reports from physicians and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the program and take the initiative in making decisions and taking actions to further these goals.

The above functions require the following abilities and skills:
* Read, interpret, and process large quantities of printed information.
* Ability to be clearly understood by verbal communication in face-to-face encounters and by telephone, read printed and written data, assimilate pertinent information in order to compose written correspondence.
* A strong command of the English language and be able to communicate well verbally and in writing. Must be able to understand verbal and written directions.
* Engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis. Respond and assist other employees and visitors, as required.
* Ability to organize focus on task is essential.
* Compare database and file material on an ongoing basis.
* Build and/or maintain simple Excel spreadsheets. Manually record data, by use of a computer and keyboard.
* Travel to and from different destinations, including inpatient and outpatient care areas.
* Maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, etc.

EDUCATION:
Required: Bachelor's Degree
Preferred: Master's Degree Public Health or related scientific field.

EXPERIENCE:
Required: Three years Research study or direct patient care experience obtained from nursing, data gathering or other related experience. With preferred degree one year experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.
Preferred: Experience with research is a must, consenting, managing multiple projects, screening patients.

The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.

This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.

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: 177908
  • Employment Status: Full-Time
  • Employee Status: Regular
  • Work Week: Days
  • Minimum Salary: US Dollar (USD) 57,500
  • Midpoint Salary: US Dollar (USD) 72,000
  • Maximum Salary : US Dollar (USD) 86,500
  • 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

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About the Company

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MD Anderson