Senior Clinical Research Associate/Clinical Research Associate II, Medical Device (Home-based) - Genae, an IQVIA Business

Objective of the job

To manage, initiate, monitor and close the clinical sites participating in clinical research in compliance with the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and genae SOPs under the supervision of the clinical project manager and/ or sponsor.

Major responsibilities

To monitor and validate study data, whether on site or in-house according to the applicable SOPs and requirements outlined in the clinical investigational plan (CIP) (if any);

To ensure the participating sites perform clinical research  according to the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and CIP requirements;

To report on the activities and provide site and patient status information in a timely manner to the Clinical Project Manager;

To attend and contribute to project meetings and trainings as required;

To ensure that project management tracking systems/ databases remain updated;

To act as an intermediary that facilitates a timely and accurate communication flow between the involved parties which may include genae employees, clinical sites, sponsors and third-party vendors;

To pro-actively identify project related issues and discuss strategies with the Clinical Project Manager on how to handle these efficiently;

To represent genae in a professional manner at all times; interfaces with internal and external customer.

Other duties

Perform miscellaneous job-related duties as assigned

Qualifications

Education: Higher educational degree (BSc, MSc) in a medical or science-related field; pharmacy, nursing or equivalent healthcare professional qualification preferred.

Experience: At least one (1) year of clinical research experience as a Clinical Research Associate, a Data Reviewer or a Study Coordinator or equivalent.

Professional skills

Clear, effective written and verbal communication;

Fluent in English, by preference in more languages;

Pro-active problem solver;

Strong organizational, planning, collaboration and team-building skills;

Ability to work according and towards expected timelines and within budget;

Computer proficiency with Microsoft Office;

Detail-oriented;

Flexible;

Data analysis skills: interpret data and communicate the importance of it, present facts and defend recommendations logically, give context to all corners of the team, be able to set strategies and priorities and address sub-optimal performance.

Working conditions

The working conditions will involve regular up to intensive national and international travelling.