Clinical Trial Associate
The Clinical Trial Associate is responsible for providing broad support for clinical trial management. S/he will assist the clinical project managers and other members of the team with day to day clinical trial execution and maintenance activities. This role will be responsible to ensure proper tracking and maintenance of clinical trial data. This role contributes to the overall compliance and completeness of clinical files. This role provides extensive clinical trial administrative support to the Clinical Operations team, to ensure efficient and effective conduct of clinical trials, in compliance with SOPs, policies and local regulatory requirements. This role is expected to take initiative and to propose solutions to problems as they arise, proactively proposes process improvement, SOPs, policies, guidelines, and focus on continuous improvement of clinical trial processes.
Clinical trial support:
· Ensure study documents are tracked, file, maintained, and archived in audit ready condition; maintain clinical trial master files and clinical trial management system (CTMS) tracking throughout the course of the study according to departmental SOPs and ICH-GCP
· Manage the collection, submission and review of important trial related documents · support translations of study related documents where applicable
· Manage user access for clinical trial related systems · maintain and disseminate study contact lists and trackers
· Assist as needed with site selection activities
· Maintain working relationship with investigators, staff, CROs and vendors
· Assist Clinical Operations team in ensuring sponsor oversight of CROs and vendors
· Assist with processing and tracking of study and vendor budgets.
· Ensure timely processing and tracking of invoices and payments and liaising with Finance when necessary
· Assist with managing queries from sites and provide site support as needed
· Prepare materials and obtain documents to assist sites with IRB/IBC submissions
· Develops and maintains study-specific forms and files; assists with clinical document generation, review and revisions
· Provide initial quality control (QC) of operational data
· Assist with clinical compliance to SOPs, procedures and regulatory requirements by actively requesting and completing required forms and documents
· Facilitate written and verbal study communication to internal program team/functions, CROS, vendors, site personnel, and consultants
· Attend study team, development/strategy team and departmental meetings; support the organization of study specific meetings
· Assist project managers/teams as needed
· Assist with quality assurance audits
· Post and maintain study-related information on external information sources (eg, websites) as necessary · assist with clinical supply documentation, ordering, management, and tracking
· Participate in departmental initiatives as requested
Bachelor’s degree in a scientific discipline or equivalent nursing degree required.
Working knowledge of the pharmaceutical industry, clinical research, and/or clinical trials is desirable.
Proficient in Microsoft Office applications is required.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.