Summary

We are seeking a qualified, experienced, professional who possesses advanced knowledge of clinical research practices for a full-time Research Coordinator II.  This position will function in the clinical research section of the Department of Neurology (Parkinson's Disease Clinic Center and Movement Disorders Clinic).  The Research Coordinator II will function in a capacity in which they manage, coordinate, and facilitate clinical research trials from study conception and regulatory approvals to trial execution. The Research Coordinator will facilitate IRB submissions/amendments, and FDA related communications. The Research Coordinator II will receive training, however prior experience is expected to fulfill all research aspects of this position.  The Research Coordinator II will provide professional skills involving patient related research efforts.  The Research Coordinator II is expected to perform responsibilities in a manner that promotes quality and safe patient care and customer service; adheres to the scope of practices as defined by the GCP/ICH guidelines.

The Research Coordinator III conducts multiple clinical trials, under the supervision of PI and Clinical Research Manager. This position is located at Baylor College of Medicine McNair Campus, in the Texas Medical Center. Prepare study protocols, regulatory communications and grant submissions. Facilitate study related communication across centers.

Job Duties

Serves as the primary study coordinator for assigned sponsored and/or investigator-initiated protocols. - 100%

• Prepares study protocols and coordinates study start up across collaborating centers (15%).
• Assists with the required grant submissions, FDA communications and IRB related procedures (including new protocols, amendments, renewals, and unanticipated problems) (15%).
• Maintains records and regulatory documents and records for respective research studies to ensure compliance with FDA and other regulatory entities. (10%)
• Handles interviewing, screening and recruiting patients, site initiation visits, interim monitoring visits and close-out studies, explaining processes and procedures to educate the participants regarding the respective research study. (10%)
• Schedules research participants for tests and procedures such as laboratory tests and other studies specific for the research protocol. (5%)
• Collects, processes, ship, and maintain paperwork according to procedures outlined in study protocol. (5%)
• Manages investigational drug accountability. (5%)
• Collects patient information; processes documents and enters information into a database. May obtain EKGs/ECGs and vital signs on study participants (25%).
• Maintains investigational drug dispensing accountability and shipping logs according to protocol guidelines. (5%)
• Other duties as assigned (5%)
  

Minimum Qualifications

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

Preferred Qualifications

• Master's degree in a related field.
• Knowledge and experience of regulatory aspects of clinical research is a must.
• Effective communication skills, both orally and in writing.
• Ability to understand and implement research studies and protocols.
• Interpersonal skills necessary to coordinate research studies.