The Clinical Trial Associate supports the clinical operations project team to ensure the smooth execution of clinical trial processes in compliance with regulatory guidelines and ICH / GCP standards.
This role involves managing trial documents, coordinating project activities, and assisting with compliance and audit preparation.
Key Responsibilities :
- Document Management : Manage trial documents within the Veeva Vault Trial Master File (TMF), including user access, training, and quality checks for completeness and compliance.
- Quality Control : Perform quality checks on TMF documents and resolve discrepancies, ensuring team adherence to document requirements.
- Project Coordination : Coordinate cross-functional project meetings with the Clinical Project Manager (CPM), prepare agendas and minutes, and track action items.
- Study Materials : Assist in creating study materials, including documents, presentations, and reports.
- Tracking and Metrics : Support the CPM in maintaining tools for tracking metrics such as site activation, patient enrollment, and site contacts.
- Essential Documents : Review and collect essential documents for compliance with SOPs, protocols, and regulations.
- Investigational Medicinal Product (IMP) Packet : Create and review IMP release packets and conduct background checks for potential new sites.
- Audit and Inspection Preparation : Assist study teams and sites in audit and inspection preparation.
- Process Improvement : Participate in workgroups to enhance internal processes and procedures.
- Training and Vendor Management : Assist in training CRO teams, investigators, and study members; serve as the point of contact for vendors and oversee selected vendor activities.
- Clintrials.gov Management : Update Clintrials.gov as required.
- Administrative Support : Provide general administrative support for clinical trial execution.
Requirements :
- Bachelor’s degree or nursing degree required; scientific or healthcare field preferred.
- 2-4 years of experience in clinical research or a related field, such as at a clinical site, CRO, sponsor, or clinical trial vendor.
- Good Clinical Practice (GCP) training and knowledge of clinical research guidelines.
- Experience with Veeva TMF and proficiency in MS Word, Excel, PowerPoint, and Outlook.
- Strong attention to detail, ability to prioritize tasks, and meet deadlines.
- Professional communication skills for interactions across all levels of the organization.
- Ability to manage multiple competing tasks in a fast-paced environment.
- Effective in cross-functional team settings.
Department : Direct Clients
This is a full-time position.
J-18808-Ljbffr
Clinical Psychologist - Boston, MA
We perform essential, yet non-billable clinical and administrative functions that comprise the infrastructure needed to maintain a successful, busy practice so that you can focus on your clinical work. Arlington, Auburn, Boston, Brookline, Cambridge, Canton, Chelmsford, Concord, Danvers, Easton, Fr...
Travel CT Tech - $2,378 to $3,178 per week in Boston, MA
Perform routine maintenance and warm-up procedures on CT scanners to prolong equipment life and ensure optimal performance. In this role, you will operate CT scanning equipment, capturing high-quality diagnostic images of patients' internal organs and tissues. Operate CT scanning equipment to ob...
Clinical Trial Associate
This role requires someone that is highly organised and understands clinical operations, including the management of administration and logistic tasks in relation to trial feasibility, start-up through to close out of clinical trials, sampled management and site liaison. Managing compliance includin...
Associate Veterinarian - Boston MA Open
We are looking tohire an Associate Veterinarian to join our practice. Innovative associate healthand wellbeing department (Headspace app subscriptions Vaultfinancial wellness tool and access to additional mental healthresources). Health/dental/visioninsurance infertility benefits gender affirmations...
Sales Associate - Boston-Seaport, MA
Sales Associates Responsibilities include:. Promote company programs including: Mastercard acquisition, Outdoor Discovery Schools, along with Diversity, Equity, Inclusion, and sustainability. Employees are expected to be active participants in health and safety by following all safety policies and p...
Clinical Trial Manager
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role. CTM levels reflect the experience, skill level, and capacity to mana...
Account Manager Associate - Boston, MA
B2B sales experience with formal sales training. Demonstrated performance record with clear documentation of success . Applied Medical Field Team Members must be able to meet third party credentialing requirements, which may include but are not limited to COVID-19 vaccination. The range displayed re...
Administrative Associate in Boston, MA (University Setting)
Administrative Associate in Boston, MA(University Setting). Assist with scheduling meetings, coordinating events, and managingcalendars. Maintain accurate records and databases. Strong organizational and time management skills. ...
Senior Clinical Research Coordinator Facility: Beth Israel Deaconess Medical Center Boston, MA 07/22/2024
Responsible for managing/overseeing the recruiting, screening and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. May enroll patients onto clinical trials. Verifies information with clinical research nurse and...
Admin Asst II - Clinical Pract Facility: Beth Israel Deaconess Medical Center Boston, MA 07/19/2024
Responds to requests in a timely manner and provides clear, accurate information within scope of knowledge and authority. Obtains patient information and materials as needed from referral sources. Prepares patient records for clinical activities and maintains patient records for physicians. Maintain...