Clinical Research Associate
Clinical Research Associate
Are you passionate about quality of the study delivery and want 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 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 Clinical Research Associates with Oncology clinical research experience to join our talented and motivated team. 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
What will you be doing?
As a CRA of APTUS you will demonstrate your expertise in managing investigational sites. Conduct monitoring visits for protocols that are complex and/or require knowledge in advanced therapeutic areas. 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
Required Knowledge, skills and abilities
• 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
• Ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Minimum Required Education & Experience
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
Who will you be working with?
Aptus Clinical was founded by three former AstraZeneca Colleagues who between them have more than 75 years experience in the Drug Development arena. Our mission is to be the trusted partner of choice for life science/ biotech companies and academia in their quest to identify and develop valuable new medicines.