Supports clinical operations through administrative support of functional leads to ensure successful completion of project deliverables and effective management of clinical trials. Provide leadership to junior department and project team members.
DUTIES AND RESPONSIBILITIES:
- Perform designated in-house project activities via use of knowledge regarding the application of ICH/GCP guidelines, applicable regulatory requirements, Standard Operating Procedures (SOP), and study-specific requirements for assigned projects.
- Serve as main point of contact for all study team members. Assist team members with requests for access to project-specific systems.
- Maintain contact lists and information for project team members and sites.
- Work with project teams to assist in tracking, naming and routing of essential documents to Clinical Records team for filing in the Trial Master File(TMF). Prepare weekly reports from tracking tools and other ad-hoc reports as requested.
- Assemble site-specific regulatory binder and distribute to sites.
- Maintain and ensure completeness of TMF throughout duration of study by tracking site documents for expirations as well as collecting, reviewing, naming and submitting essential documents to the Clinical Records team for filing in TMF. Complete regular quality checks on TMF files to ensure audit readiness.
- Processing, distributing and tracking of documents as required for protocol amendments and other updated study or site-specific documents.
- May perform assigned administrative tasks to support team members with clinical trial execution.
- Attend project team meetings and training sessions according to project and/or Sponsor requirements.
- Coordinate meetings (e.g. investigator, kick-off, team, etc.) and prepare meeting agendas, minutes and action items as needed.
- Monitor number of hours/tasks available for study activities per project specifications; escalated discrepancies in a timely manner.
- Assist with feasibility and site identification activities as needed.
- Assist with TMF management activities as needed.
- Assist with mentoring and training of department staff and new-hires.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- High School Diploma/Certificate or equivalent combination of education, training and experience; Bachelor’s degree or equivalence (BS/BA) preferred.
- Experience working in the pharmaceutical, biotechnology, or CRO industry and knowledge of the clinical trials process required.
- Experience in document collection and review required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Excellent interpersonal and organizational skills with strong attention to detail.
- Good customer/client relationship management and proactive problem-solving skills.
- Knowledge of the principles, methods, and procedures of clinical research.
- Good computer skills including MS Word, Excel, PowerPoint, Outlook.
- Experience with ICH/GCP documentation and process preferred.
- Ability to assess, coordinate, and organize/reorganize workload of
multiple projects in accordance with project priorities/assignments and timelines with focus on execution.
CONDITIONS OF EMPLOYMENT:
- Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
- No or very limited travel is required.
We are committed to diversity in the workplace and are an equal opportunity employer.