Summary

The individual will coordinate day to day activities of human subject research protocols.  This will include screening, enrollment and monitoring of research subjects.  This position requires a person that can manage multiple tasks with a high attention to detail.  This position involves accurate data collection, documentation, and ensuring overall safety of human subject participants.  

This position will be working directly with physicians and investigators to treat and follow up on study patients. Must have a working knowledge of FDA Good Clinical Practices, and the ability to read, analyze, and interpret information. Position at this level operates independently, or with only minimal guidance, the significant and key aspects of a large clinical trial or all aspects of one or more smaller clinical trial or research project. This position is able to execute all the key functions of clinical research coordination job role.

Job Duties

• Facilitate multiple clinical trials according to protocols including coordination and regulatory for Clinical Research.
• Contacts patients for research studies and informs them about the research study.
• Coordinates with the research team and schedules research participants for tests and procedures such as laboratory tests, X-rays, and other studies specific for the research protocol.
• Assists with travel and lodging for research participants.
• Assists patients in getting research study procedures.
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
• Obtains medical records.
• Orders supplies and equipment.

Specific job duties

• Accurate data collection and data entry in an electronic database.
• Respond to data queries.
• Organize study visits - arrange travel through travel agency; make appointments with various departments.
• Conduct drug accountability.
• Package and ship frozen and ambient lab specimens.
• Participate in protocol specific training such as anthropometric measurements, ECGs.
• Contribute to study budget development.
• Must be experienced with computer files and spreadsheets.
• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• Oversee study-related documentation.
• Adheres to FDA Good Clinical Practices outlining the standard for safety, design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies.
• Adheres to Baylor College of Medicine, Texas Children's Hospital and Clinical Research SOPs.

Other duties for patient care

• Obtains medical records.
• Facilitates the conduct of genetic testing for patients.
• Works with the inpatient consult team to coordinate genetic testing follow up for inpatient genetics services. 
• Retrieves and submits test results to appropriate party.
• Orders supplies and equipment.
• Acts as a team member to facilitate the provision of clinical care and performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• Two years of clinical research experience.
• GCP Training certificate (CITI or Others) - CCRP or CCRC preferred.
• Ability to multi-task is critical to this role.  Working on several studies will be required.