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Senior Coordinator, Clinical Studies - Radiation Oncology Clinical Research

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Research
💼
Radiation Oncology 115100
📅
119714 Requisition #
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The primary purpose of the Senior Coordinator, Clinical Studies position is to provide independent and advanced patient care services and operational management for clinical trials.  Impacts research protocols and the patients enrolled in designated protocols.  Ensures strict adherence to the policies and procedures of the institution.

 

The salary range is min $ 59,600 mid $ 74,500 max $ 89,400


KEY FUNCTIONS:

1. Coordination and oversight of activities related to initiation and conduct of clinical trials: 

* Work with staff in Patient Business Services / complete 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 CORE.

* Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.

* Coordinate, evaluate, and follow the patient’s participation in clinical settings.  Provide collaborative oversight for 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.

* Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA 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.

* Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.

* Cost Analysis

* Provide leadership for a multidisciplinary team to effectively meet protocol goals.


2. 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.


3. 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 CORE 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 assessing 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.

* 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.

 

4. Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators:

* Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into a computerized database or on a handwritten case report form.

* Generate PDMS data reports, protocol summary reports, and user-generated data reports as requested.

* Compile protocol and other data for manuscript submissions.

* 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 site initiation and training meetings.

* Additional projects, as assigned.


5. Training and mentoring:

* Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.

* Assist with supervisory functions such as counseling employee in regard to institutional policies and procedures.

* Provide input for performance evaluations.

* Provide training and guidance with regard to the policies and procedures that are related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.  Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.

* Plan, design, and conduct complex professional and ancillary staff education and disseminate information by means of training sessions/presentations and/or written communications.

* Conduct department training sessions to insure protocol compliance and dissemination of new information and policies.


6. To maintain a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences.

* Attend department research meetings and conferences.

* Attend approved off-site meetings and conferences.

* Supplement education as needed through use of reference materials, lectures, etc.

* Be punctual in arriving at all professional functions.

* Inform appropriate staff and arrange coverage for necessary functions when absent.

* 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.


7. 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:

Must be able to read, interpret, and process large quantities of printed information.  Must possess the 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. Must have 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. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis.  Must be able to respond and assist other employees and visitors, as required.


Ability to organize focus on task is essential.


Must be able to compare database and file material on an ongoing basis. Must be able to build and/or maintain simple Excel spreadsheets.  Must have the ability to manually record data, use a computer and typewriter keyboard.

Must have the ability to travel to and from different destinations, including inpatient and outpatient care areas.  Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, etc. 


Working Conditions

This position requires:

Working in Office Environment

 

No

 

X

Yes

Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)

 

No

 

X

Yes

Exposure to human/animal blood, body fluids, or tissues

 

No

 

X

Yes

Exposure to harmful chemicals                    

X

No

 

 

Yes

Exposure to radiation

X

No

 

 

Yes

Exposure to animals

X

No

 

 

Yes

 

 

 

 

 

 

Physical Demands

Indicate the time required to do each of the following physical demands:

 

Time Spent

Never

0%

Occasionally

1-33%

Frequently

34-66%

Continuously

67-100%

Standing

 

 

X

 

Walking

 

 

X

 

Sitting

 

 

X

 

Reaching

 

X

 

 

Lifting/Carrying

 

Up to 10 lbs

 

 

X

 

 

10lbs to 50 lbs

 

X

 

 

 

More than 50 lbs

X

 

 

 

Pushing/Pulling

 

Up to 10 lbs

 

 

X

 

 

10lbs to 50 lbs

 

X

 

 

 

More than 50 lbs

X

 

 

 

Use computer/keyboard

 

 

 

X

 

 


EDUCATION:
Required: Bachelor's degree in Public Health, Healthcare Administration or related scientific field.

EXPERIENCE: 
Required:  Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field -OR- three years of required experience and two years experience as a Coordinator, Clinical Studies at M. D. Anderson.  May substitute required education degree with additional years of equivalent experience on a one to one basis.

Preferred: Clinical research experience. 

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