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7330 - Clinical Research Specialist

Assist in initiation, conduct, completion, and reporting clinical studies/trials for all HANDS in Autism program research projects, primarily including the Collaborative Classrooms and the HANDS Summer Training Program. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.

Responsibilities include:

• Assist in development and implementation of teaching tools for subjects and families • Serve as an advocate for the subjects and their family • Prepare and submit Institutional Review Board (IRB) documents (i.e. Informed Consent, advertisement, protocol and protocol summary) • Prepare regulatory documents for sponsor • Assist in developing advertising and other information materials for recruitment • Identify and schedule screening procedures and review results • Design recruitment strategies • Monitor enrollment goals and modify recruitment strategy as needed • Monitor study team compliance with required study procedures and GCP standards • Compose and submit continuing review/amendments/close out information • Schedule study-related meetings and training sessions • Provide instructions to study team for specific study assignments • Educate staff regarding scientific aspects of study • Train ancillary staff regarding clinical trial • Participate in preparation and negotiation of study budget • Reconcile study budget accounts with Business Manager • Audit documents and pertinent files and prepare for storage • Archive documents for study per sponsor/government/institutional requirements • Maintain current knowledge of regulatory affairs and/or issues • Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings • Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study • Prepare and organize space for study related equipment and supplies • Record and document protocol deviations • Communicate with Principal Investigator (PI) and sub-investigators about changes in the trial • Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs • Maintain follow-up to determine resolution of adverse event • Capture and record adverse events data • Compose adverse event reports for oversight agencies.

The successful candidate will have experience working with the developmentally disabled or children with behavior disorders, a theoretical understanding and philosophical appreciation for behavioral intervention in a medical setting, the ability to work as a team player and communicate effectively with staff, parents, and clients, maintain accurate and organized records, work with some level of independence, and be proficient with Microsoft Office products.

Required: Bachelor's degree in Science or health-related field from an accredited institution with at least 1 year health-related or research experience; or any Bachelor's degree/Associate's degree in Allied Health professions with 3 years health-related or research experience or 2 years experience in clinical research. Bachelor's degree in Nursing; or Associate's degree in Nursing with three years health-related experience; or LPN/Diploma in Nursing with four years health-related experience. Appropriate licensure required. Master's degree in Science or health-related field with no experience required; or Master's degree in other fields plus 2 years health-related experience or 1 year experience in clinical research. Preferred: Clinical Research Certification.

Indiana University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, religion, age, sex, sexual orientation or identity, national origin, disability status, or protected veteran status. This institution is also a provider of ADA services.