Job Summary :
The Senior Clinical Research Coordinator (CRC) is responsible for managing and overseeing the day today operations of clinical trials, recruiting and screening study participants, as well as documenting and reporting on the daily operations of assigned trials. Working in collaboration with the Principal Investigator , the Sr. CRC is responsible for the oversight, facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The Sr. CRC works collaboratively with the entire team, sponsors, and monitors to ensure productivity, quality, and timely completion of studies.
The Sr. CRC is expected to support, guide, train, demonstrate and lead clinical trial team members in the implementation of trial related activities. The Sr. CRC applies critical thinking and creative problem solving skills across a wide variety of clinical studies, and contributes to the development of new processes, procedures, tools and training to enhance clinical research activities and is accountable for adhering to quality standards.
Job Responsibilities :Manages and oversees the day-to-day operations in the administration of the clinical trial activities at the site-level (i.e., direct interactions with study participants).Regularly interfaces with current and potential clinical trial participants to determine eligibility and consent of study participants in alignment with clinical trial protocol.Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.Contributes to the training of clinical trial staff and accountable for compliance with the operational requirements of the clinical trial.Function as participants' primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events).Manage participant visit scheduling and technical troubleshooting, escalating issues to the appropriate individual(s)Solicit and record information regarding safety events and preparing safety event documentation for review by the Principal Investigator.Provides accurate and timely data collection, documentation, entry, and reporting in both Sponsor and Walgreens databases.Supports the regulatory staff in the maintenance of regulatory documents in accordance with Walgreens SOPs and applicable regulations.Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.Maintain regular contact with the Principal Investigator and team to review study details (e.g., progress, adverse events, enrollment).Maintain study supplies and issue appropriate participant stipends.Ensures appropriate credentialing and training of the study team.Facilitate meetings with the study monitors, auditors, and investigators.Ensure timely response to queries and documentation of study related issues.If applicable, disburses investigational product, manages inventory of equipment and study supplies, and provides patient education regarding administration, as necessary.Contribute to the development and implementation of tools, processes and training to enhance the administration and execution of clinical studies (for example GCP, ALCOA C)Accountable for site compliance with subject safety reporting, escalate issuesDemonstrate professionalism and apply basic leadership practices in all aspects of the roleTrain and support study team members on a range of communication and teamwork best practicesPerforms other duties related to the clinical trials as delegated by the Principal InvestigatorAbout Walgreens and WBA
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170-year heritage of caring for communities. WBA's purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation's medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide.
Basic Qualifications
High School/ GED and at least 3 years (BA is PQ only) of experience in Clinical trial coordination.Working knowledge of ICH GCP, US CFR, and HIPAA regulations.Experience working independently and making appropriate decisions to operationalize and move clinical trials forward.Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail.Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.Willing to travel up to or at least 35% of the time for business purposes (within state and out of state).
Preferred Qualifications
Proficient with phlebotomyDecentralized/hybrid clinical trials experience