An Assistant Clinical Research Coordinator will join a team of experienced staff at Circle Clinical Research, whose mission is to advance health equity through clinical research. This position supports ongoing needs of trials and is responsible for the day-to-day management and execution of clinical trials, ensuring research studies run smoothly by recruiting eligible participants, collecting accurate data, monitoring participant safety, and maintaining compliance with all regulatory guidelines and ethical standards. This position requires excellent oral and written communication skills, a collaborative approach to teamwork, and an ability to work independently with close attention to detail. Competencies in the following areas are desired:
Operations – Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others. Maintains participant level documentation for all studies. Employs strategies for meeting recruitment goals and to maintain retention rates. Screen participants for studies. Assist with development of SOPs. Maintains study level documentation for all studies.
Ethics – Under supervision, identifies Adverse Events, and determines whether or not they are reportable. Collaborates with Investigators to determine AE attributes. Conducts and documents consent for participants. Assists with the development of consent plans and documents for participants. Under supervision, for non-complex studies (e.g, registries), develops and submits documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Data – Collects and enters data for research studies. May score scripted or validated tests and measures. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs. May assist with development of data entry or collection SOPs or tools. Independently uses and implements technology to enhance productivity of process. Learns and uses new technology when required.
Study and Site Management – As directed, attends or schedules site visits. Uses clinical research trial management system and its reports to manage research participants’ activities, calendars, tracking/marking financial milestones, and all aspects of study visits. May train others. Assists with ensuring that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor)
Leadership – Demonstrates resilience and is adaptive to change. Excellent problem solving skills. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
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