临床研究助理（CRA-合同）

Clinical Research Associate (CRA – Contract)

Are you an independent contract CRA passionate about advancing human health? Are you driven by a constant desire to enhance your exposure to industry leading clinical trials? Are you ready to work with a company leading multiple projects with a shared sense of purpose? If this grabs your attention, please consider the opportunity below.

Beaufort seeks a skilled and dedicated Contract Based Clinical Research Associate with experience supporting in vitro diagnostic (IVD) clinical trials. We participate in an exciting and growing industry. We share our passion, knowledge and commitment to our projects and clients. Our clinical team works with multiple sponsors in multiple therapeutic areas with an emphasis in IVD.

A Clinical Research Associate at Beaufort holds the following key responsibilities:

• Build relationships with investigators and site staff

• Understand the protocol and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel

• Monitor patient recruitment timelines at sites and report this information to the project leadership.

• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol, SOPs and adherence to applicable regulations and GCP compliance

• Participate in Investigator and other external or internal meetings as required

• Perform site qualification visits, initiation visits, interim monitoring visits, and close-out visits as necessary

• Responsible for conducting source data verification and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit

• Update all relevant tracking systems on an ongoing basis

• Generate site visit reports and expense reports within specified timelines

• Arrange on-site visits and logistics (e.g., travel arrangements)

• Conduct on-site study-specific training (if applicable)

• Maintain day-to-day contact with the study sites, including regular telephone contact with the sites as agreed with Sponsor and Project Manager

There is a great amount of depth and breadth in this role. Because of this, we ask that you bring with you the education and/or experience that sets you up for success in this position. This generally looks like:

• Bachelor's Degree required

• Must have at least 5 years of experience as a field monitor CRA

• Experience monitoring IVD clinical trials is required

• Experience working in a self-driven capacity, with a sense of urgency and limited oversight

• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)

• Must have excellent communication and interpersonal skills

• Demonstrate flexibility regarding project or organization shifts in priorities

• Ability travel: at least 1 to 2 site-visits per week (regionally)

• Familiarity and working knowledge of electronic data capture systems (eDC), clinical databases, Case Report Forms, edit checks, query resolution, and resolving data management issues

While the above are the standard requirements, you’d really impress with:

• If you were well versed in current industry standards (GCP, ICH, FDA) and guidelines

• If you had a proven track record of monitoring sites and executing successful projects

• The ability to work with multiple sponsors in multiple therapeutic areas and indications

This position reports to Beaufort’s CRA Manager. As a contract role, it offers flexibility and the opportunity for you to partner with a great team.

Beaufort offers a different CRO experience. It’s not just about what we do, it’s how we do it. Together our team brings a level of passion knowledge and commitment to our projects and clients. We foster a culture of excellence specializing in in vitro Diagnostic clinical project management and regulatory support.

At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.

Beaufort is an equal opportunity employer and values diversity.

Originally posted on Himalayas