Senior Clinical Research Associate

Beyond Drug Development is a privately owned specialty CRO focusing on early-stage product development, advancing innovative products for clients worldwide.  

Opportunity

Due to our successful growth, we are looking for enthusiastic and talented individuals to join our clinical operations team. 

****The role is a remote (work from home) position for a Senior CRA. Preference is for the applicant to be based in Sydney, NSW. ****

We will also consider Melbourne and Adelaide based applicants.

Senior Clinical Research Associates (CRAs) play a crucial role in ensuring our Clinical Research projects are executed with the quality that each client and project requires. They are the driving force of clinical operations and play a lead role in every clinical trial.

With the ever-evolving industry landscape, we offer an oasis where we value our people by providing a flexible working setting and a collaborative environment where everybody’s experience, opinions and ideas are not only heard but actively sought after. We have a values-driven culture that is built from the ground up. Our leaders are at the frontline with you, committed to advancing science and going above and Beyond for our clients but most importantly, for our team. 

As a boutique early phase CRO we offer a unique opportunity to be a part of an incredibly exciting journey in the establishment of one Australia’s newest CRO’s – one you can’t get anywhere else, with a team unlike any other.

What you will do

Senior CRAs responsibilities involve the same tasks and expectations to that of a Clinical Research Associate (CRA) but are expected to take on additional duties such as:

• Providing mentorship to Clinical Research Associates and Project Administrators.
• Ability to take a lead role in the conduct of a project (per project). This may include:
  • Acting as the main contact for a project with the support of a Project Manager and Clinical Operations Manager;
  • Ability to perform financial payment tracking (site payment tracking) and reconciliation to site clinical trial agreements;
  • Negotiation and preparation of site clinical trial agreements.
• Attend and Lead project team meetings.
• Assist in the production and delivery of presentations, as needed for project, departmental, sponsor and/or business development presentations. 
• Assist with investigator budgets negotiations and with the execution of site contracts with support. 
• Conduct feasibilities to determine appropriate site selection/identification for clinical trials. This may include the development of feasibility tools such as a communication tracking log, feasibility questionnaire and support in developing feasibility reports.

Senior CRAs responsibilities also include those same tasks and expectations to that of a Clinical Research Associate (CRA) such as:

• Responsible for managing the research activities at Australian sites (largely early phase research) including Phase 1 Units and other private/public research sites.
• Be in communication with the medical site staff including coordinators, Clinical Research physicians, and their site staff.
• Conduct all types of visits – site qualifications, initiation, monitoring and close out visits.
• Performs source data verification including:
  • Identification and reporting of trends/emerging issues;
  • Identification, reporting and follow up of SAE’s (where not already identified by the sites);
  • Liaises with data management to resolve data discrepancies and ensure all data management;
  • study goals are met;
  • Prepares accurate and timely visit reports from all types of visits.
• Ensure adherence and compliance with ICH-GCP and applicable local and international regulations and Standard Operating Procedures (SOPs).
• Assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• On-site and (where required) remote monitoring activities. This may require interstate travel.
• Support Clinical Project Manager and other team members as required.

****Please note the applicant must have at least 4 years experience at CRA level or above******

What the applicant must bring to the role

• A degree in life sciences or equivalent 
• Excellent knowledge of ICH-GCP     
• Excellent Knowledge of Australian regulatory environment 
• Superior interpersonal, oral, and written communication skills in English 
• Exceptional organizational skills with attention to detail 
• Knowledge of the pharmaceutical industry, terminology, and practices 
• Ability to work with minimal supervision 
• Proficiency in Microsoft Office, CTMS, eTMF and EDC Systems 
• Strong attention to detail and focus on quality of work
• Strong organizational and problem-solving skills

Beyond Drug Development BDD