Clinical Research Associate

Job Description

Brief Position Description:

As a Clinical Research Associate, you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring clinical sites, maintenance of study files, conduct of pre-study, initiation visits, regular visits, close out visits, and liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to the Clinical Operations Lead, you will be a key member of the Clinical Operations team in the United Kingdom. We are searching for an ambitious and energetic person, able to undertake challenges in the project, push forward development of the project, and function well in the project team. The desired person shall be open to cross-cultural communication and cooperation and shall be significantly independent in their performance.

Minimum Qualifications & Experience:

1. Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/guidelines
2. Excellent organizational and time management skills
3. Skills to handle multiple priorities and to work with deadlines and under pressure
4. Excellent written and oral communication skills
5. Skills to coach and mentor other clinical staff
6. Fluent in written and verbal English

Job Responsibilities:

1. Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor
2. Responsible for monitoring clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits, and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
3. Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues
4. Assists in Business Development activities
5. May have supervisory functions in clinical projects
6. May be required to train, coach, and supervise junior staff

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.

We are looking for people who are passionate about working in clinical research and biotech, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

About Us

Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

About the Team

Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.

It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States, and the UK.