Clinical Trials Research Associate - Developmental Behavioral Pediatrics

The Research Associate will be responsible for several aspects of managing and coordinating major research studies.  This may include reviewing medical records to identify potential subjects with autism, recruiting and consenting participant families, supporting a national recruitment program and online behavioral testing, data collected through the “BabySteps” research smartphone tool, performing basic behavioral tests, arranging for blood or buccal swab collection, organizing previously acquired data, and analyzing results.  Specifically, blood and cheek cell samples will be analyzed to look for changes in epigenetic patterns over time, comparing newborn samples with those collected around the time of diagnosis.  This position offers a rewarding combination of involvement in cutting-edge research, patient communication, and genetic and epigenetic analyses.

The Research Associate will be supervised by Dr. Lane Strathearn in the Attachment and Neurodevelopment laboratory, located in the Center for Disabilities and Development. The research is part of the Hawkeye Intellectual and Developmental Disabilities Research Center (Hawk-IDDRC) and is funded by the National Institute for Child Health and Human Development (NICHD). This is a specified term position.

Duties to include:

•          Assist in the design, development, execution, administration, and maintenance of protocols and clinical studies, and oversee data management.
•          Assist in study design and protocol development and provide input into descriptions of complex research procedures.
•          Oversee CRF development. 
•          Develop complex study materials.
•          Serve as a liaison to local health care practitioners, agencies, and sponsors.
•   Screen, recruit, enroll, and obtain informed consent for clinical trials and research studies, including families with a child who is being evaluated for possible autism and healthy subjects as research participants.
•         Oversee the recruitment of subjects and scheduling of study procedures.
•          Educate study participants on the scope of the study, potential risks and benefits, possible alternatives, and study requirements for participants.
•          Relay information to the principal investigator and verify study participant eligibility.
•          Participate in the design, development and testing of clinical research trials data systems.
•  Assist families to provide questionnaire and videotaped data through a smartphone tool, from the mothers of patients and healthy participants.
•          Validate data, query resolution, and make recommendations for resolution.
•          Revise and implement change in data collection.
•          Manage and organize regulatory documentation from regulatory authorities and prepare regulatory submissions.
•          Perform on-site audits of research and clinical data. 
•   Develop procedures for on-site data audits; design and generate reports for use in data audits; summarize results of audits and write reports. Resolve all monitoring visit issues.
•          Monitor compliance with regulatory guidelines and proper maintenance of documents.
•          May recommend corrective action for reportable events.
•          May communicate with IRB staff and investigators and assist with IRB submissions.
•          May provide functional and/or administrative supervision. 
•          Mentor new staff under direction.
•          Administer and/or monitor budget for studies.
•   Assist with data analyses.
•          Manage data sets and maintain highly organized and detailed research records.
•   Help to prepare items for publication, such as figures and tables.
•   Perform general administrative tasks as assigned.

About the Department of Pediatrics:

The Stead Family Department of Pediatrics is a national leader in pediatric medicine.  The Department's mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatments and cures for

childhood illnesses and educating the next generation of pediatric health care providers.  The Department comprises the medical and research staff of UI Stead Family Children’s Hospital.  UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions, and Iowa’s only comprehensive children’s hospital.

About the Division of Developmental and Behavioral Pediatrics:

The Division of Developmental and Behavioral Pediatrics (DBP) provides compassionate and state-of-the-art clinical care for children with a variety of challenges and difficulties, including developmental delays (cognitive, language, social, behavioral, motor), intellectual disabilities, autism spectrum disorders, hearing/vision impairments, ADHD, learning disorders (such as dyslexia), disruptive behavior disorders, and cerebral palsy. The DBP Division also provides leadership for the UI Stead Family Children’s Hospital Autism Center, which is a collaborative program of the Stead Family Department of Pediatrics and the Department of Psychiatry. The Division is housed within the nationally-renowned Center for Disabilities and Development (CDD) which integrates clinical service with research (through the Hawkeye Intellectual and Developmental Disabilities Research Center, or Hawk-IDDRC), education (including the Leadership Education in Neurodevelopmental and related Disabilities, or LEND, program), and community outreach, as Iowa’s University Center for Excellence in Developmental Disabilities (UCEDD).