Clinical Research Coordinator I or II

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon Center needs. Similarly, not all duties that have been outlined will be assigned to each position.

Study Start-Up:

Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
Assist with creation and editing of study documents, such as protocols, consent forms, and subject communications.
Study Maintenance and Regulatory Compliance:

Recruitment, enrollment, consent, and tracking of participants.
Collect and organize participant data.
Assist with preparation of annual review documents and progress reports.
Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
Verify accuracy of study forms.
Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
Documents patient visits and procedures.
Quality Assurance:

Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
Prepares data for analysis and data entry.
Administrative Support:

Performs varied administrative support duties as required.
Communicates professionally and effectively with internal and external study collaborators, including investigators, sponsors, and monitors.
Plans and coordinates trainings and/or conference calls with external collaborators.
Conducts literature searches.
Assists PI to prepare complete study reports.
Assists Investigators with the preparation of posters and analyses for publication.
Skills/Abilities/Competences:

The candidate should:

be well-organized, self-motivated, and attentive to detail;
be able to multi-task, problem-solve, function in a fast-paced environment, and manage time/work-load with minimal supervision;
have excellent interpersonal communication skills to effectively communicate with a multidisciplinary team and research participants;
have the ability to work independently, take initiative, and interact with clients and colleagues of multiple disciplines;
cultural sensitivity and humility in working with older adults and stakeholders in community settings;
be proficient in using administrative software (Excel, Word, PowerPoint), electronic healthcare records, webpage development, and electronic data capture systems (e.g. REDCap, Qualtrics);
demonstrate respect and professionalism for subjects’ rights and individual needs;
have a working knowledge of clinical research protocols;
have analytical skills and the ability to resolve technical problems;
have an ability to interpret acceptability of data results; and
have a working knowledge of data management programs (e.g. SPSS, SAS).