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Population Based and Clinical Studies Coordinator

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Research
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Rad Onc Clinical Research 710593
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126295 Requisition #
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The primary purpose of this Clinical Studies Coordinator position in Radiation Oncology Research is to provide clinical evaluation, coordination, implementation, and monitoring of patients enrolled in clinical research studies, including both observational, population-based, and therapeutic studies.


This Clinical Studies Coordinator will also serve as an effective point of contact regarding status and progress of selected research trials and assists with management of protocols, including drafting protocol revisions and amendments. This position impacts patients in enrolled in designated protocols and requires strict adherence to the policies and procedures of the institution. The Clinical Studies Coordinator will utilize medical or clinical knowledge for supervised non-clinical patient interaction for the purposes of research data gathering and monitoring.


The ideal candidate will have a Master's degree or higher in Public Health, Epidemiology or related field and experience working with survey data or other large data sets. 


SUMMARY

  • Under supervision of medical staff and research nurse staff, assists the investigator in the overall conduction of the research protocols assigned.  Participates in the departmental protocol review and submission process and actively participates in protocol meetings such as investigators and initiation meetings as required.
  • Manages protocols at appropriate intervals and participates in monitoring and audit activities.  Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies.  Develops and maintains systems for the coding, editing, and computer entry of data for assigned research studies focusing on continuous patient follow-up.
  • Designs and maintains management reports on the databases for various research studies.  Provides guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards.  Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
  • Assists the investigator in data file preparation and participates in data review meetings as requires by the department.  Enters data and maintains management reports on the databases for various research purposes including, but not limited to Tissue Station.  Prepares specific protocol reports and analysis to aid decisions regarding therapeutic efficacy and to assist in manuscript preparation and grant submissions.
  • Performs protocol-specific duties under the direct supervision of the protocol PI and the research nurse manager/supervisor, clinical study supervisor or research nurse including but not limited to screening and determination of eligibility of potential new patients, assisting in the informed consent process, scheduling and tracking of protocol-specific tests in order to maintain protocol compliance, and administration of patient-reported outcome instruments.  Effectively follows patients on protocol by maintaining knowledge of adverse events and response to treatment.

KEY FUNCTIONS


Coordination of activities related to initiation and conduct of clinical trials and observational studies.

  • 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 participating in 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 all assigned trials, and maintain patient safety.
  • Conduct patient surveys and questionnaires in-person and by telephone.
  • 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 Human Subject Research Manual.
  • Provide support in providing coverage to protocols assigned to other research staff.
  • Assist with protocol drafting and amendments.

 

 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 protocol and patient information needed for protocol continuing review.
  • 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 Human Subject Research Manual.
Direct support to research protocols.
  • Review protocol documents including abstracts, text and informed consent for relevant information.
  • Register patients on research protocols as needed by verifying eligibility/exclusion criteria and entering patients in CORe per protocol.  Communicate necessary registration information to sponsor company as directed by PI, and with the assistance of the research nurse.
  • Gather relevant patient information related to adverse events through patient direct contact and or chart review.
  • 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 Human Subject Research Manual.

Assist the primary investigator in collection and evaluation of data. 
  • Administer patient-reported outcome instruments as per protocol.
  • 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 Human Subject Research Manual.
  • Additional projects, as assigned.
Collect or facilitate the collection of patient data or specimens as outlined in assigned protocols upon request.
  • Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.
  • Process patient data (manage paper, touchpad, web-based, or telephone survey data).

  • Develop and maintain database for tracking specimens/ patient data 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 Human Subject Research Manual.

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 and web-based databases (e.g. REDCap).  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 in Public Health, Healthcare Administration, or related scientific fields.

 

Preferred:   Master’s Degree in a related field; Bi-lingual; Certification in a related field or specialty.

 

 

 

Experience

 

Required:    Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience.  Additional years of related experience and/or education may be substituted on a one-for-one basis.


QUALIFICATIONS

Education
Required: Bachelor's degree.

Preferred: Master's degree or PhD in Public Health, Epidemiology, Biostatistics or related field.

Experience
Required: Three years of 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.

Preferred: Experience working with population-based studies. Research experience at MD Anderson Cancer Center. Experience using REDCap is a plus.



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

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