[Hiring] Senior Clinical Research Associate @ClinChoice

Role Description

As a Senior Clinical Research Associate (Senior CRA), you will manage 2–3 clinical trials and be responsible for site management activities, including:

• Study start-up
• Site monitoring
• Closeout

You will conduct both on-site and remote monitoring while supporting a variety of studies across a diverse client portfolio, from emerging biotech companies to large pharmaceutical organizations.

This is a permanent, fully remote position. Candidates must be willing and able to travel to investigative sites as needed.

Main Job Tasks and Responsibilities:

• Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.
• Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate.
• Train site staff in all study procedures.
• Conduct periodic monitoring visits, including completion of monitoring visit report.
• Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF).
• Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data.
• Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
• Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• Act as the main contact person for the site to ensure close follow up.
• Provide general support to the Clinical Research Division on quality control of clinical data.
• Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner.
• Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• Develop training material and give training in collaboration with the Training & Qualification Management Unit.
• May assist with contract negotiation with sites on study budget after appropriate training.
• Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project including submission requirements, timelines, informed consent development, etc.
• Guide and supervise Clinical Research Associate I (CRA I) to coach and train them on the job.

Qualifications

• University Degree in scientific, medical or paramedical disciplines.
• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred.
• Previous experience working for a CRO is required.
• At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate (CRA) performing on-site monitoring activities.
• Experience with oncology, respiratory and complex trials is required.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.

Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Company Description

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

• Our employees are the most valuable company asset.
• 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.
• We celebrate diversity and inclusivity among our employees.