Clinical Research Coordinator II/III - Behavioral Medicine & Clinical Psychology

JOB RESPONSIBILITIES

• Study Conduct/ Clinical Research Practice - Assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor. Assemble lab kits and/or gather supplies. Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set. Ensure specimens are properly logged, handled and stored. Follow direction of clinical research coordinator or others involved in the clinical research project work. Assist other staff members and coordinators to implement studies. Maintain inventory of supplies and equipment. Operate standard laboratory and research study equipment, if applicable. Troubleshoot and correct erroneous results or problems with equipment.

• Regulatory Compliance and Documentation - Identify regulatory activities to be completed and takes the initiative to complete. Coordinate and participate in the assembly of materials. Assist in maintaining up-to-date and accurate written and electronic records and files to support clinical research activities. Assist with audit readiness records review and preparation activities. Assist with maintaining protocol specific SOP's, IRB and regulatory correspondence. Demonstrate an awareness of federal regulations; state and local law; GCP/ICH and CCHMC policies to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Recognize the importance of reporting concerns of ethical and/or regulatory issues to supervisor in a timely manner. Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with the institution and division SOPs. Seek out research educational opportunities.

• Recruitment/Enrollment/Retention - Maintain awareness of status of all active studies. Identify potentially eligible participants. Coordinate, plan and execute study visits and provide instructions and reimbursement to participants. Approach potential participants and families in a professional manner. Conduct pre-consent screening procedures according to protocol specifications to determine eligibility. Review consent form with participant and provide time for participant to consider study participation. Execute the informed consent process according to Good Clinical Practices (GCP), CCHMC procedures and other applicable policies. Communicate with participants' clinical team regarding study participation as indicated by protocol and/or manual of operations. Document in applicable systems (tracking, electronic health, etc.) participants approached, screened and enrolled in the study. Communicate challenges with recruitment and retention to the study leadership. Provide recommendations to improve recruitment and retention to the study leadership.

• Communication - Assist with organizing and filing all correspondence. Refer questions and issues that arise during study conduct to the appropriate research team member. Maintain awareness of study related issues involving investigators, sponsors, coordinating centers, study coordinators, clinical team, managers and other institutions. Maintain relationship with participants. Dev