Essential Duties and Responsibilities:
- Communication - Maintains timely and effective communication among team members and investigational site staff. Act as a site manager for all assigned investigational sites. Possess the ability to anticipate/identify potential issues and develop a plan of corrective action.
- Regulatory Documentation - Assist in the collection and tracking of regulatory documents for clinical trial start-up and IRB submissions and management and completion of clinical trials; provide oversight of Contract Research Organization (CRO) managed clinical trials to ensure these activities are completed. Participate in TMF and on-site audits as requested; may require guidance to respond to findings.
- Document Preparation/Review: Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, recruitment materials and other study related tools. Review initial protocol and protocol amendments for consistency and accuracy. Assist with the management of reports that detail the clinical study information and progress such as investigator site contact information, subject screening and enrollment, data collection, documentation of adverse events, and investigator payments.
- Monitoring - Assumes responsibility for site management and site staff performance to ensure corporate timelines for enrollment and data collection are maintained. Have the ability to independently conduct site qualification visits, site initiation visits, routine monitoring visits and close out visits. Assures compliance with all protocol requirements, effective patient identification, timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations, proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials, and regularly reviews the status of the contents within the site regulatory binder. Monitors study specific vendors with regard to patient activity (e.g central laboratory data, photography data, etc.).
- Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Performs clinical data listings reviews/remote monitoring as needed.
- Reporting and Tracking - Completes and submits visit reports according to Aclaris’s SOP. Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment targets and data quality. Updates study and patient status information for Sr. Clinical Operations Director/Sr. CRA. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
- Administrative - May prepare site payment tracking for management review. Prepares for and attends Investigator meetings. Assists with the preparation of study start up materials and tools. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
- Develop and maintain current working knowledge of the disease state & product under study.
- Performs other work-related duties as assigned.
- Travel requirements: up to 50% travel.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.