Temporary Clinical Research Assistant
Are you passionate about quality of the study delivery and wanting to work in an innovative and exciting company that aims to partner with clients to deliver innovative and tailored solutions for the delivery of clinical studies?.
Have you got phase I or II experience in Oncology trials?
Are you looking for a role with flexibility and opportunity to grow and develop?
Aptus Clinical supports life science companies and academia in their quest to identify and develop valuable new medicines. We have a passion for drug development and a belief in the power of collective knowledge and collaboration.
The Aptus Clinical Team is a highly-talented, diverse team of professionals dedicated to driving clinical trial delivery solutions for our clients, enabling patients to access new and developing therapies.
We are seeking Associates with with Oncology clinical research experience to work with us as Clinical Research Associates. Accepting this challenge you will be joining a fast growing and exciting company that puts knowledge, partnership and driving the right outcomes for clients front and centre in its philosophy.
As a Clinical Research Associate, you will have the opportunity to demonstrate your expertise in managing investigational sites as well as conducting monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. You will also ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
While projects vary, your typical responsibilities might include:
- Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation aligned with ICH GCP
- Supporting the development of a subject recruitment plan
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites
- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and clients. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements
To be considered, you will need:
- A bachelor’s degree in a health care or other scientific discipline or educational equivalent
- A minimum of 2 years of on-site monitoring experience; or equivalent combination of education, training and experience
- In depth knowledge and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- An ability to manage competing priorities
- An ability to establish and maintain effective working relationships with coworkers, managers and clients
In return, we are able to offer competitive daily rates and the opportunity to work on some exciting and challenging projects.
To apply, please attach your CV and quote job reference JMC/CRA.