Clinical Project Associate II

Synteract - USA - Clinical Project Associate II Carlsbad, CA or Morrisville, NC Who We Are Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases. Position Overview As a Clinical Project Associate II you will provide administrative and trial support to clinical projects thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). This position can be based in Carlsbad, CA or Morrisville, NC. Specific tasks would include: Interfaces with Client representatives and Synteract project team. Assists project teams with selective aspects of trial management from start-up to close-out on one or more projects. Provides support in creating the Trial Master File (TMF) and/or Investigator site files; with oversight, assists with maintenance tasks such as tracking and filing for the duration of the project, and with preparation for audits and archiving. Provides support with set-up, access requests, and maintenance for project systems (e.g. AX, CTMS, EDC, Shared Drive). Assists with maintaining and updating project-related data in an existing database, (e.g. CTMS, DMS) which may require contacting internal team members to gather information. Generates and formats project-related data in reports and compiles data as requested. Assists with the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations). Assists in the receipt, collection, tracking and review of essential and non-essential documents. Assists with development of Investigator Grants. Assists with potential site identification and facilitates site outreach activities for feasibility projects (e.g. CDA execution, Feasibility Questionnaire completion by sites). Assists with the administration, reporting and reconciliation of site payments. Assists with translation of project documents. Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings). Assists with maintaining of project team lists. Assists with completion of relevant project team training tracking. Provide other project support to functional teams as directed by Line Management. Maintains and updates project-related data in an existing databased (e.g. CTMS, DMS) which may require contacting internal team members to gather information. Assists with the adaptation of Informed Consent Form templates at site level, dependent on regional variances. Job responsibilities are focused on project team support to ensure timely completion of project tasks and deliverables. Job tasks related to this support are may include, but are not limited to the following: Assists with the adaptation of Informed Consent Form templates at site level, dependent on regional variances. Assists with the development of and updates to project-related plans and site manuals. Provides site and CRA support in the receipt, collection, tracking and review of essential and non-essential documents and distribution of project-related communications. Assists with compilation of project-related packages (e.g. for IP release, regulatory submission) . Assists with potential site identification and facilitates site outreach activities for feasibility projects (e.g. CDA execution, Feasibility Questionnaire completion by site). Administers, reports and reconciles site payments. Develops Investigator Grants. Supports contract and budget negotiations with sites. Assists with translation of project documents. Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings).Assists with maintaining of project team lists. Assists with completion of relevant project team training tracking. Qualifications University degree in a related field of study desired. A minimum of 1 year applicable industry or administrative experience required. Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. Proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook. Effective verbal and writing skills; English + local language, if relevant. This job excludes Colorado applicants. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.... - Permanent - Full-time

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