The Sr. Clinical Research Associate will assist the Sr, Director of Clinical Operations and the clinical team in the day to day activities for managing clinical study conduct to support completion per established project team goals and objectives. The scope of this position is Phase 1 through 4 clinical studies.
+ Lead the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.
+ Conduct and/or oversee clinical monitoring (site qualification, site initiation, interim monitoring, study closeout visits) activities to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. May include monitoring visit report review and/or participating in co-monitoring visits.
+ Assist in study set-up including but not limited to eCRF design, protocol review, informed consents, investigator selection, study related operational manuals, training materials, and various study plans (e.g., visit logs, monitoring plan, etc.).
+ Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed.
+ Collaborate with cross-function study team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Aclaris SOPs.
+ Mentor lower level CRAs.
+ Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and. or submission of regulatory documents to the TMF and ongoing document reconciliation.
+ Assist in maintaining accurate and up to date study information within relevant tracking systems
+ Effectively communicate with study team members and work closely with Sr. Director of Clinical Operations to address study related challenges.
+ May participate in process improvement and quality-related initiatives associated with study execution and deliverables
+ Responsible for complying with regulations and guidelines and ensuring adherence to these during study conduct.
+ Travel Required: up to 25-50%, depending on stage of development program
+ Aclaris’ office is located in Malvern, PA. Depending on the level of experience of the candidate, this position may be filled with a qualified candidate that is not local to the Malvern PA area.
+ Minimum of 3 years of field based clinical monitoring experience
+ Ability to work independently under general direction in a fast-paced environment
+ Ability to multi-task and change direction quickly
+ Must have excellent interpersonal, written, verbal, presentation, administrative and computer skills
+ Fluent in English (oral and written)
+ 25%-50% travel required, depending on stage of development program
+ Dermatology experience
+ Science background
Street: 640 Lee Road