Avance Clinical Looking for Clinical Research Associates II & III at Newark, New Jersey Full Time

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s.

If you already work in this industry you’ll know that we are experts in our field. We have a global footprint with staff in the US, Australia, New Zealand and India & offer early to late phase services.

Why should you join Avance Clinical?
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We understand that having great people means we can grow and develop our business to provide the best solutions to sponsors.

We’re making a significant investment in our US operations which will see our numbers grow considerably over the next 24 months.

Opportunity
We’re seeking experienced Clinical Research Associates to join us as CRA II’s or CRA III’s. We have a number of positions available and can consider full-time & contract arrangements. With you being based in Boston / Chicago / Houston / Texas.

As we continue to grow, we want our people to grow with our organisation. We offer training and career development opportunities to build the skills and progress the careers of our employees.

Responsibilities

• Manage and track clinical trial progress on recruitment/site selection, site readiness, IRB/EC submissions, subject enrolment, etc.
• Act as site liaison to Clinical Trial Associates, Clinical Trial Managers, Vendors or Sponsor Representatives.
• Act as primary contact for sites and other staff for site-related inquiries and issues.
• Participate in or lead (as requested by the Clinical Trial Manager), project calls and provide updates on projects as appropriate.
• Prepare appropriate, timely and accurate communication to internal and external teams, consultants and investigative site personnel.
• Lead or assist with clinical trial start-up activities including collection of regulatory documents and review of clinical and project-related documents.
• Conduct on-site visits (Qualification, Initiation, Interim, Close-Out) to monitor study progress, prepare timely reports, and assure compliance with protocol-requirements, applicable regulations, ICH/GCP and Company Standard Operating Procedures.
• Confirm the collection of laboratory samples as specified in the project or clinical trial and the resulting lab data when central laboratories are used.
• Participate in Company or Sponsor required training programs.
• Perform necessary administrative functions (e.g., tracking of expense reports, time, and attendance).
• Maintain home office (e.g., procurement of office supplies, submission of documents).
• Mentor and/or train CRA-I or CTAs as requested.

Requirements

• Prior experience monitoring clinical trials, within the US. 
• A degree in life science or other healthcare-related discipline.
• Ideally a minimum of between 2 to 5 years of experience working as a Clinical Research Associate with ideally a minimum of 4 to 8 years overall industry experience
• Solid knowledge of FDA regulations, US drug development process, clinical trial monitoring procedures, ICH/GCP guidelines, and medical terminology are essential. 
• Ability to travel within North America up to 60% of the time
• Excellent written & verbal communication skills
• On top of this, you will need to be able to show initiative and work well autonomously, with minimal supervision. 
• CRO experience desirable

What we offer

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are working together on a common goal
• Flexible work options
• Great tools / tech to do your job
• A competitive salary, good industry benefits & an extra days vacation for your birthday!

What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.

• To join our team please submit your resume & cover letter as one Microsoft Word document
• You must also have full US working rights to be considered
• To apply for this role please click on the ‘APPLY’ link and submit your RESUME along with a cover letter. The cover letter should document why you would make a great addition to the Avance Clinical team. Please submit the RESUME and cover as one document.
• As we receive a high volume of applications for our vacancies, we will only contact you directly, should you be successful through to the next stage of our recruitment process.
• No agencies please

Adrian Bedford, Talent Acquisition Specialist, Avance Clinical – (url removed)