Clinical Research Coord- Hema/Onco Job

Children's Health - Research Careers

Job Number: 43186

Location: Dallas, TX

Date Posted: 12-3-2016

Description:

Position Summary

The Clinical Research Coordinator may coordinate device and drug treatment research trials, as well as observational studies conducted at Children's Medical Center, including but not limited to study set-up, implementation, fiscal monitoring, and data collection/entry. Usually serves as the Children's employee managing the coordination of all aspects of the assigned research project(s) at Children's in support of the Principal Investigator and ensuring compliance with all Children's policies, state and federal regulations that govern clinical research.

Essential Duties and Responsibilities

  • Requires in-depth professional knowledge and practical/applied expertise in own discipline and basic knowledge of related disciplines within the broader professional field
  • Has knowledge of best practices and how own area integrates with others; demonstrates awareness of the industry, including regulatory, evolving customer demands, and the factors that differentiate the organization in the market
  • Acts as a resource for colleagues with less experience; may lead projects with manageable risks and resource requirements
  • Solves complex problems and takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
  • Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies
  • Works independently, receives minimal guidance
  • Explains difficult or sensitive information; works to build consensus
  • Evaluate patients for inclusion and exclusion criteria on multiple protocols. Consent and enroll subjects on trials as appropriate. Be familiar with treatment and visit schedules for assigned studies. Coordinate/perform scheduling of procedures and treatments and serve as an educational resource for participants regarding study requirements. Be proficient at reviewing medical records to assess patient’s disease status, treatment course, and adverse events. Complete case report forms and submit to sponsor according to deadlines. Participate in long-term follow-up efforts on research participants and submit on-going data. Communicate with pharmacy to ensure investigational drug is ordered per protocol when needed. Clinically licensed coordinators may be responsible for administering study related medications.
  • Open and maintain institutional approval for research studies including but not limited to initial UT Institutional Review Board submissions (creating consent forms, HIPAA forms, project summaries), new research questionnaires for IRB and Children's Medical Center Research Department, amendments, annual reviews and adverse event reporting. Consult with Children's Medical Center Research Department to establish study budgets and ongoing oversight of research billing to ensure compliance with laws regarding research billing. Communicate with sponsor to keep all documents updated. Communicate with physicians and clinical staff regarding patient research participation.
  • Coordinate sample procurement according to protocol and disease. Maintain samples of fluids and/or tissue in a sterile condition and promptly distribute to local and national clinical and research laboratories. Assist in labeling and storing of blood, urine and other specimens for analysis. Collect, correlate and file patient records and laboratory data for analysis. Receive reports and facilitate Principal Investigator review of results. Package and ship samples according to local and federal IATA guidelines. Reconcile shipment billing.
  • Requires occasional attendance at out of town professional meetings.
  • Participate in professional development programs such as staff, departmental, UTSW research community, and national meetings in disease specific areas.
  • Performs other position appropriate duties as required in a competent, professional, courteous manner
  • May be required to work outside normal business hours.

Qualifications

Education

  • Four-year Bachelor's degree or equivalent experience, required
  • Graduate or professional work or advanced degree; or equivalent experience, preferred
  • Bachelor's degree in related sciences or clinical license, required

Licenses & Certifications

  • CCRP/CCRC certification through SoCRA /ACRP, preferred

Experience

  • Minimum 1 year of related experience, required
  • Clinical Research experience - coordinating, monitoring or regulatory and or pediatric clinical experience, preferred

Specific knowledge, skills, and abilities

  • Clearly convey information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
  • Ensure that the customer perspective is a driving force behind business decisions and activities; craft and implement service practices that meet customers' and own organization's needs.
  • Meet patient and patient family needs; take responsibility for a patient's safety, satisfaction, and clinical outcomes; use appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence.
  • Ensure that the customer perspective is a driving force behind business decisions and activities; craft and implement service practices that meet customers' and own organization's needs.
  • Develop and use collaborative relationships to facilitate the accomplishment of work goals.
  • Identify and understand issues, problems, and opportunities; compare data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Take prompt action to accomplish objectives; take action to achieve goals beyond what is required; be proactive.
  • Deal effectively with others in an antagonistic situation; use appropriate interpersonal styles and methods to reduce tension or conflict between two or more people.
  • Effectively manage one's time and resources to ensure that work is completed efficiently.
  • Accomplish tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
  • Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks; self-impose standards of excellence rather than having standards imposed.
  • Assimilate and apply new job-related information in a timely manner.
  • Clearly convey information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.

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