- Coordinate and perform single and/or mass mailings/communications to sites (FedEx, electronic mailings, broadcast fax, etc.), including trial equipment and/or consumables.
- Coordinate and/or support activities associated with trial-related meetings (e.g., Investigator Meetings, Steering Committees, etc.).
- Format trial-related documents (e.g. newsletters, slides, clinical trial reports, protocols, etc.), including hyperlinking and/or Quality Control (QC).
- Distribution and tracking of trial-related information (e.g., IVRS envelopes, IND 7/15 Day Reports, etc.).
- Support Inspection Readiness activities, such as, but not limited to: Local and/or Global Trial Master File (TMF) reconciliation and supping and/or maintaining sharerooms
- Trial Master File (TMF) activities, such as, but not limited to: submitting documentation to Trial Master File (TMF), including addressing discrepancies, redaction, etc., and reconciling of trial documents and Run reports, as requested
- Create and/or obtain information for trial-related portals (e.g., BlueSky, CT Web, IRB).
- CMTTS Access Database: Logging & tracking (e.g., contact information, schedules, receipt of trip reports) and running reports
- Site Management System: Data entry (e.g., site/staff information, trial staff assignments, milestone date, etc.), and running reports
- Central Database Inventory - tracking, distribution and return of trial-related equipment and consumables.
- Data entry and tracking of various trackers, databases and/or sharerooms (e.g., CO tracker, RDR Tracker, RDC user accounts, vendor, drug reconciliation, etc.)
- Triage CO electronic service mailboxes
- Support the creation and approval process of trial-related Purchase Orders (POs)/Purchase Requests (PRs)
- Trial invoice processing: rejecting and/or approving trial-related invoices, and resolving issues regarding invoice queries
- Support Management of Site Records retention
- Organize and coordinate local and/or global meetings (e.g. Medical Sub-Team, Advisory Boards, etc.) across various OPUs, including the preparation of meeting minutes.
- Format documents (e.g. slides, minutes, reports, etc.), including Quality Control (QC).
- Collect documents (e.g. CDAs, etc.).
- File documents (e.g., Idea for Gen).
- Access, obtain, and/or download information/documents/reports from various sources, including but not limited to the following: JReview, MYTrials, Myclinphone, ACI portal, , etc.; Publications and/or abstracts from online database; BI Reference Documents in BIRDS
- Distribute narratives and track review
- Assign resource assignments and run reports in the Site Management System
- Assist in the set-up and maintenance of share rooms
- Excellent oral and written communication skills
- Ability to work independently and in a team environment
- Proficient in Microsoft Office and direct working experience in multiple electronic platforms such as but not limited to: Share Rooms, Clinical Trial portals, Central IRB portals, Time reporting portals, Learning portals, Access Databases, ability to work on excel spread sheets, Microsoft Lync, Adobe Acrobat Professional and scanning software etc.
- Ability to use and learn other system applications
- Detail-oriented
- Good problem-solving skills
- Good customer-service skill and quality orientation.
- Basic knowledge of ICH, GCPs, applicable FDA guidelines, and industry standards.
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Clinical Administrative Associate - Ridgefield, United States - McInnis Inc.
Description
*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct, and completion of clinical trials, including Clinical Development & Medical Affairs (CDMA) operational support. Candidates should be highly motivated resources with the ability to think critically, be detail-oriented, multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by the company.
Duties and Responsibilities
The Clinical Associate supporting Clinical Operations may perform the following tasks, but not limited to:
4 year college degree or relevant experience
Desired Experience, Skills and Abilities:
