Senior Clinical Research Associate

Arbor Research serves as the data coordinating center for the NIH-funded Childhood Liver Disease Research Network (ChiLDReN) and the privately-funded WIND-PSC study. This role will support both of these multi-site research studies. Characteristic Duties and Responsibilities Monitors study sites' protocol compliance, maintenance of regulatory documents, and quality, timeliness, and accuracy of data. Looks for and proactively identifies and addresses patterns that lead to loss of data integrity. Independently performs remote and onsite monitoring, possibly requiring overnight travel and possibly internationally. Independently performs site initiation visits (virtual training of study site coordinators on the study protocol and data management system) and site close-out visits. Independently prepares reports that detail monitoring activities and issues addressed at site visits. Works with vendors handling samples and supplies and the analytic team to reconcile discrepancies in sample marking. Serves as liaison to study coordinators and responds to questions regarding protocol and case report form (CRF) interpretation. Support may be required outside of normal working hours due to study site physical location or time-sensitive situations. Leads the development and revision of study Manual of Operations and Standard Operating Procedures, Protocols and Consent forms, testing process of electronic data entry interfaces, and development of electronic data entry user manual. Collects and reviews regulatory documents from clinical sites. Independently works with external sites to meet regulatory requirements and obtain IRB/REB/Ethics Committee approval. Effectively communicates queries to study sites and communicates sites' responses to the sponsor(s) with minimal oversight. Oversees and approves study registrations at ClinicalTrials.gov. Independently works with protocol committees to develop and update protocols. Drafts agendas, facilitates meetings, and manages action items for standing calls with study sites. Leads network-wide all-coordinator calls, including drafting agendas and presentation materials. Oversees first-line support for queries/issues received from study sites regarding the data management system and works with the Arbor Research Information Services team on expected support workflow. Oversees/supervises the implementation of the clinical monitoring aspects related to 21 CFR Part 11 requirements. Provides recommendations in response to protocol questions and/or data management system issues received from sites that may need discussion and further attention from internal staff to resolve and/or make updates. Assists with proposal development and/or grant writing. Core Values Our core values define who we are as an organization and serve as the foundation of our code of ethics. Arbor Research expects all employees to embody these and demonstrate them in our day-to-day work. Collaborative Spirit . We expect each staff member to learn from and teach one another and ask each to exhibit a curiosity and respect for the contributions of others. Creativity . We strive to cultivate a challenging, stimulating, and supportive environment where our employees are expected to be inquisitive, take initiative, and demonstrate ingenuity. Credibility . Our employees are smart, thoughtful, and objective in their work. We expect them to be technically solid in their area of expertise, and for those conducting research to demonstrate scientific rigor. Dedication . Our team achieves success because of our dedication to carrying out high quality work and delivering trusted results. Supervision Received General administrative supervision is received from a Research Scientist or Senior Research Scientist. Close collaboration is expected with clinical monitors and other project team members. Supervision Exercised None at this time. Future direct reports may include Clinical Research Associates (level I, II, and Senior). Required Qualifications Bachelor's degree plus 8 or more years of experience as a research study coordinator or clinical monitor CCRC (Certified Clinical Research Coordinator) Certification Thorough knowledge of HIPAA and GCPs (Good Clinical Practice) Excellent customer service and organizational skills Excellent written and verbal communication skills Proficient in Microsoft Word, Excel, PowerPoint, and SharePoint Demonstrated ability to utilize available resources and work independently with little to no direction Clinical research, epidemiology, or laboratory background Desirable Qualifications Experience working in a data coordinating center overseeing multi-site research studies Clinical background (e.g., RN) Experience working in liver diseases Experience with pediatric studies Experience with FDA Investigational New Drug (IND) applications Master's degree in public health or similar discipline Clinical trial experience Annual Salary Range $79,200 - 127,400 (US National Average) Base Compensation Determination Base Compensation is determined by market range and geographic location pay zones. Base Compensation also includes various individual factors unique to each candidate such as job level, prior experience, skill set, certification and educational which may impact the compensation structure. This position is classified as exempt according to FLSA guidelines Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.