Good Clinical Practice (GCP) training is widely used as the industry standard for ensuring investigators are qualified to conduct clinical trials. The Clinical Trials Transformation Initiative (CTTI), a public-private group, has released recommendations proposing a new approach for investigator qualification that goes beyond GCP training and features a targeted approach that includes protocol-specific preparation. (ctti-clinicaltrials.org)
ACRP developing competence standards for Principal Investigators
The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles. ”By developing and helping to implement this new PI initiative, ACRP and its partners are taking a major step forward to advance excellence in clinical research.” — Jim Kremidas, ACRP Executive Director. (ACRP.net)
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Navigating your Path to a Clinical Operations Career
Transitioning into a Career in Clinical Trial Management (Sponsor) by Herman Liu Before I started my career in clinical operations, I was a technician on a production floor manufacturing oncology drugs. I had an unrelated job, and I eventually was able to transition into a clinical operations career at a Read more
San Francisco Bay Area faces “talent crisis” in the life sciences
San Francisco is one of the top national life sciences and digital health hubs. It’s also one of the most competitive labor markets in the world, especially in life sciences and digital companies. There is a growing concern in the region over whether there is enough of a talent pool to keep the companies at full employment. Robin Toft, CEO of Toft Group Executive Search, offers suggestions for employers on what they can do to stay competitive for labor in the Bay Area. (medcitynews.com)
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Spotlight: Clinical Researcher Elizabeth Weeks-Rowe, LVN, CCRA
Interview and article by Tatsiana “Tanya” Verstak This interview is part of our new series where we interview notable clinical researchers, others in the field, and companies about innovative new services. We begin today with Elizabeth Weeks-Rowe from San Diego. Ms. Weeks-Rowe has 17 years of research experience, including work as Read more
Interview with 17-year CRA about her experiences in clinical research
Elizabeth Weeks-Rowe, LVN, CCRA, a San Diego-based clinical research trainer and writer, is interviewed by Dan Sfera (“the clinical trials guru”) about her perceptions and experience in clinical research over the past 17 years. Ms. Weeks-Rowe is also the author of the novel, “Clinical Research Trials and Triumphs: A Heart Warming Novel Following a Nurse’s Journey Into Clinical Research.”
ACRP develops competency guidelines for Clinical Research Coordinators
The Association of Clinical Research Professionals (ACRP) has released the clinical research industry’s first-ever competency guidelines for Clinical Research Coordinators (CRCs). This announcement follows last year’s release of the Core Competency Framework for Clinical Study Monitoring, which lists the core competencies required of individuals involved in clinical study monitoring. (ACRP.net)
Looking for a life science consultant? Ask Clora!
Clora, a Boston startup, just received $3.3 million in a seed financing round led by Spark Capital to create an online marketplace where life science executives can quickly hunt for outside experts needed to bring a new treatment to its next stage. Clora’s aim is to speed up the consultant recruitment process from months to days, and expand the options for companies beyond local talent pools. (Xconomy)
Pharma companies are recruiting top talent from tech giants like Google and LinkedIn
GlaxoSmithKline, Johnson & Johnson, and other pharma companies are actively recruiting technologists from companies like Google and Microsoft’s LinkedIn, to help modernize the processes that big pharma uses to discover and develop new drugs. According to a GSK spokesperson, there are plenty of opportunities for tech workers to build machine learning tools that analyze health information. An ongoing project may use previously-collected clinical trial data as an alternative to a control arm in a study, which could potentially reduce the cost of clinical trials and provide a better patient experience. (CNBC)
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CTTI Report: Recommendations for strengthening the investigator site community
Recommendations for sponsors, CROs, and health systems/private practices I. Recommendations for developing site-based research infrastructure & staff Recognize principal investigators, co-investigators, and research coordinators as key contributors to product development Provide opportunities for investigators and site staff to remain engaged in between trials II. Recommendations for optimizing trial execution and Read more