Skip to main content

This job has expired

Freelance Clinical Research Associate, Croatia - L

Employer
ClinChoice
Location
Croatia
Salary
Competitive
Start date
25 Jan 2023
Closing date
24 Feb 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Description:
Location: Croatia - Home-based and Site Visits

Schedule: Freelance, 0.2-0.4 FTEs

CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Research Associate. This role is with our clinical operations team in Croatia, it involves 3 sites with 0.2-0.4 FTEs. The therapeutic area involves psychiatry.

The Freelance CRA monitors clinical studies and assures high-quality clinical data.

Join our team and help us deliver clinical trials that will improve patients' lives.

Main Job Tasks and Responsibilities:
  • Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned
  • Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure a good start-up of the investigation sites
  • May act as Feasibility Associate after appropriate and documented training
  • Performs training site staff in all study procedures to ensure protocol/ICH-GCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP, and ICH-GCP requirements to ensure data integrity and subject safety
  • Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data
  • Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site
  • Cooperates with the site staff for ensuring proper reporting from the site of safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g., archiving) guaranteeing smooth completion of the project
  • Will be the main contact person for the site to ensure close follow up
  • Provides general support to the Clinical Research Division on quality control of clinical data
  • Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned
  • Reports to the Head of the Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed upon for each single clinical trial
  • Develops training material and gives training in collaboration with the Training & Qualification Management Unit
  • May assist in contract negotiation with sites on the study budget after appropriate and documented training
  • Assists in the preparation of the study including CRF design/development writes CRF instructions and organizes the study files and documents to ensure good start-up of the investigation sites
  • May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.
  • Guides and supervises Clinical Research Associate I (CRA I) to coach and train them on the job


Education and Experience:
  • University Degree in scientific medical or paramedical disciplines
  • Previous proven experience as a CRA, performing on-site monitoring activities
  • Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements


Specific Role Requirements and Skills:
  • Fluent in English
  • Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)
  • Willingness to travel


The Application Process

Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.

If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Associate, CRA, Site Management, Monitor, Monitoring, Psychiatry, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent, Pharma, Outsourcing, Site Contract, Vendor Management, Feasibility Studies, ICFs, Inform Consent Forms



Skills: Psychiatry, Clinical Research Associate, Freelance, clinical trials, CRO, Feasibility, Pharma, English Location: Croatia Share:

LinkedIn Facebook Twitter Email

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert