Clinical Administrative Associate
2 weeks ago
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:
- 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
The CA supporting CDMA may perform the following tasks, but not limited to, including those associated with the CA supporting Clinical Operations:
- 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, Clinicaltrials.gov, 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
Requirements:
4 year college degree or relevant experience
Desired Experience, Skills and Abilities:
- 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.
-
Clinical Administrative Associate
2 weeks ago
Ridgefield, United States McInnis Inc. Full time*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,...
-
Clinical Administrative Associate
3 weeks ago
Ridgefield, United States McInnis Inc. Full time*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,...
-
Clinical Administrative Associate
3 weeks ago
Ridgefield, United States McInnis Inc. Full timeJob DescriptionJob 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...
-
Clinical Administrative Associate
4 weeks ago
Ridgefield, United States McInnis Inc. Full time*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,...
-
Clinical Research Associate
2 weeks ago
Ridgefield, United States McInnis Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
3 weeks ago
Ridgefield, United States McInnis Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
2 weeks ago
Ridgefield, United States McInnis, Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
1 day ago
Ridgefield, United States McInnis Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
4 weeks ago
Ridgefield, United States McInnis Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
3 days ago
Ridgefield, United States McInnis Inc. Full timeThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...
-
Clinical Research Associate
3 weeks ago
Ridgefield, United States McInnis Inc. Full timeJob DescriptionJob DescriptionThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned...
-
Clinical Monitoring Associate
4 weeks ago
Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full timeAccountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...
-
Clinical Monitoring Associate/clinical Trail
4 weeks ago
Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full timeAccountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...
-
Clinical Monitoring Associate/clinical Trail
4 weeks ago
Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full timeDepartment: CD O Site Monitoring - USBB20 Job Category: Clinical and Scientific Job Title: Site Monitoring Lead Duties: Trial Preparation: - Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of...
-
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionSourcing ManagerDuties:- Local Implementation to Category Strategy following TOM (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.Identify, evaluate and classify sourcing risks and Manage risk exposure with mitigation measures.- Identify and evaluate existing and potential local...
-
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionSourcing ManagerDuties:- Local Implementation to Category Strategy following TOM (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.Identify, evaluate and classify sourcing risks and Manage risk exposure with mitigation measures.- Identify and evaluate existing and potential local...
-
Project Manager IT
3 weeks ago
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionTITLE: Project Manager - I JOB SUMMARYUnder general supervision, responsible for all aspects of various projects of a less complex nature.Interfaces with all areas affected or supporting the project.Responsible for assembling project time, assigning individual responsibilities, identifying appropriate resources needed, and...
-
Sourcing Manager/Contract management/RFP process
3 weeks ago
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionJob Title: Sourcing ManagerDuties: - Implement complex Category Strategy following TOM and develop it for corporate center led model (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.- Bring potential innovation to Client and local market intelligence.- Identify, evaluate and...
-
Sourcing Manager/Contract management/RFP process
2 weeks ago
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionJob Title: Sourcing ManagerDuties: - Implement complex Category Strategy following TOM and develop it for corporate center led model (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.- Bring potential innovation to Client and local market intelligence.- Identify, evaluate and...
-
Medical Technical Writer, Fully Home Based
3 weeks ago
Ridgefield, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionOutside EST ZONE candidate requested not to apply.Duties:Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving...