Client is searching for a resourceful, confident, professional with on-site monitoring experience for an important role as an In-House CRA working on several fast-moving studies for one of our lead programs in the CNS space. The In-house CRA will provide support to study management tasks in collaboration with the Study Manager and/or Senior Managers, with an emphasis on leading monitoring oversight activities for our clinical CROs.
Roles and Responsibilities:
Assist the Study Manager in training CRO CRAs and creating the CRA training material
Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan, or as needed
Review Monitoring Visit Reports from the CRO
Monitor studies (PSV, SIV, IMV, COV) as needed
Escalate monitoring trends or findings to the Study Manager
Track metrics related to Sponsor Oversight and the Monitoring Plan
Assist in start-up activities of clinical research studies including Investigator Meetings, enrollment planning, and Investigator selection
Collaborates closely with study management, CRO study managers, and CRO monitoring staff, reviews site/patient activity tracking, prepares study updates and proactively identifies and solves study-related issues
Regularly communicates with Investigators to identify and resolve complex clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements;
Guides investigative site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability;
Reviews and provides input to study plans and guidelines, including study monitoring plans;
Assists in development of study documents, such as informed consent forms, study logs, and study manuals
Provide overall tactical support for the study
Lead or assist with TMF processes: set-up, training, QC, management
Collaborate with CRO counterpart
Education / Requirements:
BS/BA degree or equivalent and 4+ years experience in clinical development and operations
At least 2 years experience performing on-site monitoring conducting SIVs, IMVs, and COVs for IND regulated clinical research studies.
Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
Demonstrated effectiveness in resolving site management issues of varying complexity
Co-monitoring experience required
This role will require some travel – ranging from 10% - 50% during peak study activity
Strong communication and interpersonal/team skills
Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
Excitement about the vision and mission of company.