CRA Phase 1 Expert in Spain

Employer
Syneos Health
Location
Spain
Salary
Competitive
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
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CRA II  

Sponsor Dedicated, 

Phase I Oncology/Hematology, 

2-4 Years of Experience

Office Based in Madrid

 

Here at Syneos Health, we are looking for a CRA II to work sponsor dedicated to a top Pharma on Phase I Oncology/Hematology studies. The job location will be Madrid. We offer up to 5000€ sign on bonus!

Why us?

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Key Responsibilities:
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders;
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials;
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies);
• Recommends sites during the site feasibility and/or site selection process;
• Conducts pre-study visit as appropriate;
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation;
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, Sponsor's procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable;
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions;
• Serve as a point of contact for Sites;
• Provides trainings to sites;
• Performs site closure activities when all required protocol visits and follow-up are completed;
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory;
• Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities;
• Oversees activities of site personnel over whom there is no direct authority;
• Motivates/influences the site to meet study objectives, including enrollment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method;
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented;
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions;
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner;
• May support Ethics Committee submission, ICF review, collection of documents to/from site;
• May support ensuring access to eDC and sponsor / vendor systems is available for clinical trial site personnel;
• May support equipment calibration and tracking;
• May support preparation of Study Initiation Visit materials;
• May support coordination and ensure database lock timelines are met as required locally.
 

Requirements:

• Bachelor's or Master's degree in Life Sciences or equivalent;
• Has basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials;
• Experience in the drug discovery/development process;
• Knowledge and understanding of clinical research processes, regulations and methodology;
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management;
• Organization and time management skills;
• Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations;
• Fluent Spanish and strong English (oral & written);
• Computer/system proficiency;
• Strong/Excellent Interpersonal/ relationship skills.
 

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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