Research Coordinator - 134219

This position involves independent coordination, assistance with research trial management (including all operational components such as subject recruitment, eligibility screening, patient consenting and enrollment, scheduling visits and exams, conducting subject visits and assessments, managing electronic data and documents, and maintaining regulatory files). Coordinates and helps facilitate data entry by volunteer/other assistants, research analyses, in addition to preparation of abstracts and manuscripts.

• Independent research experience.

• Experience working with individuals affected by neurological diseases, especially Huntington's disease. Demonstrated performance in communicating effectively, and interacting sensitively and professionally with this population.

• Demonstrated ability to use findings to determine patient eligibility during recruitment and progress during study, identify potential abnormalities, and follow reporting procedures.

• Demonstrated experience working with medical charts and abstracting pertinent data from medical records throughout the community.

• Significant knowledge of FDA regulations, OPRP, HRPP, and HIPAA policies and procedures to interpret policy.

• Knowledge of the Code of Federal Regulations (CFR), Good Clinical Practice guidelines and other regulations for the conduct of clinical research.

• Good communication skills. Detail oriented.

• Experience working as a study coordinator in a clinical research environment that interacts with patients, families, physicians, and colleagues.

• Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science that is generally acquired through a Bachelor's degree.

• Knowledge of clinical trial methodologies and general clinical research data collection methods.

• Ability to work in a laboratory environment which interacts with large number of research and technical personnel and other laboratories.

• Demonstrated knowledge and experience with laboratory procedures and reported values.

• Good organizational skills and ability to prioritize work.

• Demonstrated knowledge working with clinical trials research activities, regulatory compliance, guidelines related to informed consent, ethical conduct, and protection of human subjects as well as comprehending complex research protocols.

• Demonstrated ability to work independently, make appropriate determinations, and show resourcefulness.

• Demonstrated proficiency certification for commonly used assessment tools including but not limited to the MMSE, MoCA, SDM, HVLT-r, CDR-SB, FAS.

• Knowledge of investigational drug authorization criteria. Experience working with IVRS systems to log and dispense study medication.

• Knowledge of subject compliance/adherence issues and experience solving related problems.

• Demonstrated experience preparing research studies for IRB review including new project submissions, requested revisions, amendments and project renewals.

• Demonstrated ability to work independently, make appropriate determinations, and show resourcefulness.

• Demonstrated proficiency certification for commonly used assessment tools including but not limited to the MMSE, MoCA, SDM, HVLT-r, CDR-SB, FAS.

• Knowledge of investigational drug authorization criteria. Experience working with IVRS systems to log and dispense study medication.

• Demonstrated knowledge of standard software applications, including Word, Excel, PowerPoint, Outlook, and internet browsers. Proficient in utilizing such software programs to develop reports, presentations, and documents related to various projects and tasks. Demonstrated ability to learn new software programs.

• Demonstrated experience preparing research studies for IRB review including new project submissions, requested revisions, amendments and project renewals.

• Demonstrated ability preparing financial status reports related to study activities.

• Experience creating and producing materials such as newsletters; instructional, informative, and procedural documents; and web-based publications.

• Experience handling of biological fluids and universal biohazardous materials precautions. Working knowledge of shipping of biological materials, and EH&S policies and procedures for hazardous materials and laboratory safety.

• Excellent interpersonal skills including tact, diplomacy and flexibility with the ability to work in a team framework in conjunction with principles of community and to relate professionally and collaboratively with others. Ability to maintain confidentiality, and an appropriate clinical demeanor toward a wide variety of study participants and health care professionals.

• Demonstrated high level of initiative to prioritize work to meet deadlines, and to handle problems, propose solutions, and implement them.

• Excellent writing and verbal communications skills. Demonstrated ability to communicate effectively with a variety of people from different backgrounds.

• Demonstrated knowledge of standard software applications, including Word, Excel, PowerPoint, Outlook, and internet browsers. Proficient in utilizing such software programs to develop reports, presentations, and documents related to various projects and tasks. Demonstrated ability to learn new software programs.

• Experience with general lab maintenance.

• Experience with personal computers. Ability to use database and spreadsheet software.

• Knowledge of EH&S procedures for laboratory safety.

• Blood drawing - Certification in phlebotomy and experience working with patients. Demonstrated ability to perform phlebotomy.

• Employment is subject to a criminal background check.