Senior Coordinator, Clinical Studies

Summary

The primary purpose of the Sr. Coordinator, Clinical Studies position is to provide independent and advanced patient care services and operational management for clinical trials in GI Medical Oncology. This position impacts research protocols and patients enrolled in designated protocols and ensures strict adherence to the policies and procedures of the institution.

Core Values

Caring Behaviors

  • Courtesy: Is respectful and courteous to each other at all times
  • Friendliness/Teamwork: Promotes and rewards teamwork and inclusiveness; Is sensitive to the concerns of our patients and our co-workers


Integrity Behaviors

  • Reliability: Communicates frequently, honestly and openly
  • Accountability: Holds self and others accountable for practicing our values
  • Safety: Notices a safety concern and brings it to someone's attention; Models safe behaviors (wears badge, washes hands, keeps work area clean and orderly); Mitigates risk to the institution through sound business practices


Discovery Behaviors

  • Responsiveness: By his/her actions, creates an environment of trust; Encourages learning, creativity and new ideas
  • Personal Leadership/Self-Initiative: Helps others to identify and solve problems; Seeks personal growth and enables others to do so


Key Functions - Senior clinical Studies coordinator

Responsible for the overall effective operation of designated research protocols. Performs all of the functions of a Coordinator, Clinical Studies (see below). In addition, responsible for:

  • Protocol Operations

  • overall effective operation of designated protocols to include development, design and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.

  • Training/QA/Audits

  • Trains other support staff in study coordination to include providing training and guidance with regard to the policies and procedures that are related to conduct of clinical trials; planning, designing and conducting complex professional and ancillary staff education sessions to ensure protocol compliance and dissemination of new information and policies. Coordinates FDA submissions and supervises clinical trials audits. Performs QA audits to monitor compliance and accuracy of data. Compiles protocol data for manuscript submission.

  • Team Lead

  • Assists with supervisory functions, participates in the evaluation process. Performs protocol specific activities in the enrollment, evaluation of eligibility for clinical trials, planning of treatment, adherence to protocol schedules, adverse event reporting, etc.

    Key Functions - clinical Studies coordinator
  • Coordinate for patient protocol screening and enrollment.
    • Screen patient for protocol eligibility.
    • Request insurance clearance prior to consenting patient.
    • Identify patient and coordinate scheduling follow-up appointment, labs, CT scan/MRI and other tests/procedures with data coordinators and/or PSCs at the GI Center.
    • Assist in obtaining informed consent document.
    • Pre-enroll in CORe per protocol.
    • Follow-up on screening tests/procedure for eligibility per protocol.
    • Obtain baseline data by interviewing patient/family and/or reviewing records.
    • Register and/or assign treatment in CORe.
    • Notify Patient Business Services for patient participation per protocol.
    • Complete documentation - informed consent note, eligibility note and on-study note.
    • Complete and submit research charge tickets per protocol (R0).
    • Send appointment request to CTRC and/or ATC per protocol.
    • Request outside records, tissue block/slides per protocol and maintain records.


  • Coordinate and assist patient during, after protocol treatment and off-study.
    • Coordinate protocol follow-up, labs, tests/procedures per protocol.
    • Interview patient and collect data - pill diary, toxicity, con-med and/or questionnaires.
    • Assist in assessing adverse events per CTCAE.
    • Assist in completing measurements per protocol.
    • Complete documentations - follow-up note, con-med, toxicity.
    • Maintain data in CORe/PDMS and/or complete case report forms as expected.
    • Assist in re-consenting patient as necessary.
    • Assist preparing SAE report.
    • Complete protocol deviation form as necessary.
    • Assist completing violation form and send to the Regulatory team for IRB submission.
    • Prepare for routine monitoring and/or audits.
    • Collect correlative samples per protocol and maintain records/database.
    • Complete end of study tests/procedures.
    • Complete Protocol Summary in CORe.
    • Follow patient for survival per protocol and document.
    • Assist preparing IRB Annual Continuing review, IND Annual Report, ePAAC, DSMB report per protocol.
    • Cover co-workers' patients as needed.


  • Assist the primary investigator in collection and evaluation of data.
    • Maintain screening/enrollment log.
    • Maintain informed consent binder.
    • Generate CORe/PDMS reports per request.


  • Attend meetings /conferences.
    • Attend departmental Clinical Research Review meeting including SAE review.
    • Attend departmental fellow presentation.
    • Attend bi-monthly staff meeting
    • Attend departmental quarterly meeting
    • Attend OPR presentations and classes.
    • Attend off-site conferences with approval.
    • Obtain a certification(s).


    MARGINAL OR PERIODIC FUNCTIONS:
    • Other duties as assigned.
    • This position will require a person who is motivated and willing to learn new skills.
    • Represent department in a professional and appropriate manner within the institution, as well as externally.
    • Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.
    • Requires use of typewriter and computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button, multiple line telephone set. Master new software by utilizing available resources (other department personnel, reference manual, taking classes, etc.
    • Must be able to use all office equipment as noted above. Read and understand printed and written data in English.
    • 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.

    Core Competencies

    • IC - Analytical Thinking:
      • Gather relevant information systematically;
      • Break down problems into simple components; and
      • Make sound decisions.
    • IC - Innovative Thinking:
      • Approach problems with curiosity and open-mindedness; and
      • Offers new ideas, solutions and/or options.
    • IC - Build Relationships:
      • Initiate, develop, and manage relationships and networks; and
      • Show sincere interest in others and their concerns.

    Education

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

    Preferred: Master's degree in a related field.

    License/Certification

    Required: None

    Preferred: None

    Experience

    Required: Five years of 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 of experience as a Coordinator, Clinical Studies at M.D. Anderson. May substitute required education degree with additional years of equivalent experience on a one on to one basis.

    Preferred: Research coordinator experience in oncology research.

    Working Conditions

    This position requires:

    Working in Office Environment

    ______ No

    __X__ Yes

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

    __X__ No

    ______ Yes

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

    __X__ No

    ______ 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

    xx

    Use computer/keyboard

    x

    Bachelor's degree. Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years 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: 138226
    • Employment Status: Full-Time
    • Employee Status: Regular
    • FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
    • Work Week: Days
    • Fund Type: Soft
    • Pivotal Position: No
    • Minimum Salary: US Dollar (USD) 59,600
    • Midpoint Salary: US Dollar (USD) 74,500
    • Maximum Salary : US Dollar (USD) 89,400
    • Science Jobs: No