14 feb
Syneos Health Clinical
Estado de México
**Description**
**Central Monitoring Associate II**
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves.
Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking.
- Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Assesses site compliance with electronic data capture requirements.
- May perform Remote Aggregated Data Review (RADaR)
utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project. Ability to identify trends within and across sites, escalating issues and trends to develop corrective actions / preventative actions.
- Routinely reviews the site section of the TMF or project master file (PMF) in totality for accuracy, timeliness and completeness. Requests new/updated documents from the site, as required. If remote access is available to an electronic Investigator Site File (eISF), routinely reviews the eISF for accuracy, timeliness and completeness. Reconciles contents of the eISF with the trial master file (TMF).
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations..
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- Acts as primary liaison with project site personnel or NIS reporters, in collaboration with the on-site CRA. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings, Advisory Committee Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable)
and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- For Real World and Late Phase, the CMA II may be assigned to the Registry Coordinating Center (RCC). Additional responsibilities include:
- Data review, data query resolution and direct data entry of Health Care Provider (HCP) and Patient information.
- Call center-based communications (inbound and outbound) with registry physicians, and/or patients, by utilizing web-based tools and other communication tools to ensure compliance with protocol requirements and relevan
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