·Study Conduct/ Clinical Research Practice
Provide technical and clerical support in the conduct of clinical studies. Assist clinical research personnel in the implementation of clinical research studies, including procedures and project work. 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 procedures (SOP) or other work instruction set. Maintain accurate and detailed records of all research and results. Comply with established standards for Good Clinical Practice (GCP). Maintain inventory of supplies and equipment. Operate standard laboratory equipment, if applicable. Align work directly with that of the clinical research team of the department/division. Increase knowledge and skills in clinical research.
·Regulatory Compliance and Documentation
Demonstrate accuracy and organizational skills; ability to follow through on requests and meet timelines. Assemble 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 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 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. Complete required training. Participate in educational opportunities.
Assist in the screening, recruitment and enrollment of study participants. Coordinate and plan study visits, travel arrangements, provide instructions and reimbursement to study participants. Maintain awareness of status of all active studies. Assist with the identification of potential eligible participants for non-complex study protocols. Assist with the conduct of pre-consent screening according to protocol specifications to determine eligibility. Participate in the review of the consent form with participants. Complete the informed consent process according to GCP, CCHMC procedures and other applicable policies for non-complex protocols. 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.
Assist with organizing and filing all correspondence. Assist in answering and directing incoming telephone calls; receive and communicate messages. 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 study participants. Develop a rapport with study participants. Participate in meetings and discussions related to the planning, implementation, and follow-up of clinical research studies.
Complete Case Report Forms (CRFs) and source documentation in compliance with all applicable guidelines for human research. Review CRFs to ensure completeness, accuracy and compliance with Good Clinical Practice. Enter data into various auditable databases or electronic data-capture systems. Maintain internal record keeping system(s) in conjunction with study team members.
Assemble training materials in preparation and conduct of clinical trials. Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team (as applicable). Complete required training. Participate in educational opportunities.
Ability to perform clerical functions with accuracy and attention to detail
Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself
·Follow Instructions - Adv
Ability to follow complex written and verbal instructions
Knowledge of scientific terminology
·Computer Proficiency - Basic
Working knowledge of basic computer applications
Pursuing work with little supervision or assistance; directing one's own efforts
Possess strong organization skills and attention to detail
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.
Ability to operate laboratory equipment (if applicable to position)