What We Do:
Care Entry is delivering the way forward for drugs right this moment! Care Entry has a revolutionary mannequin that breaks down conventional boundaries to medical trials that restrict participation amongst physicians and sufferers to three%. By eradicating this bottleneck, Care Entry helps speed up the approval and supply of essential and life-saving therapies.
Who We Are:
We care. Our persons are the engines behind our mission: to revolutionize entry to medical trials for the good thing about sufferers in all places. We take care of each other, discover new concepts to speed up drugs, and seed a long-term influence for generations.
Place Overview:
Care Entry is looking for a devoted, skilled, and innovation-driven High quality Assurance Specialist to supervise the High quality Division. The High quality Assurance Specialist can be liable for carefully monitoring the standard and compliance of medical work at each conventional trial websites and decentralized trials. Working in help of the Director of High quality Assurance, the High quality Assurance Specialist will make sure that Care Entry maintains a excessive degree of high quality whereas executing medical trials in response to Care Entry SOPs, GCP, and FDA/ICH Tips.
What You will Be Working On (Duties embody however not restricted to):
Present help to the High quality Division by way of the administration and upkeep of high quality methods, packages and processes
Guarantee excessive integrity of knowledge and affected person security on the analysis website by way of high quality assurance assessment
Interpret and implement high quality assurance requirements and procedures
Monitor high quality assurance audits and different high quality assurance actions
Assessment research particular regulatory binders and paperwork to make sure all paperwork are appropriately accomplished, submitted and maintained per GCP requirements
Work with analysis employees and PI to make sure recognized points are addressed
Assessment and preserve high quality assurance SOPs and procedures
Develop and observe corrective motion plans with advice and monitor comply with up preventative actions as obligatory
Coordinate and help on-site audits performed by exterior suppliers and regulatory businesses
Put together studies to speak outcomes of high quality actions
Execute yearly audit plan
Carry out different duties as assigned. The duties and duties listed above are consultant of the character and degree of labor assigned and aren’t essentially all-inclusive
Bodily & Journey Necessities:
It is a distant place with lower than 10% journey necessities. Occasional deliberate journey could also be required as a part of the position.
What You Deliver (Information, Expertise, & Talents):
Glorious working data of medical and analysis terminology
Glorious working data of federal laws and good medical practices (GCP)
Consideration to element
Potential to speak and work successfully with a various workforce of pros
Robust Organizational Expertise: In a position to prioritize, delegate, direct, help and consider others work and comply with by way of on assignments
Communication Expertise: Robust verbal and written communication abilities as evidenced by constructive interactions with coworkers, administration, shoppers and distributors
Staff Collaboration Expertise: Work successfully and collaboratively with different workforce members to perform mutual targets. Deliver a constructive and supportive angle to attaining these targets
Robust laptop abilities with demonstrated skills utilizing medical trials database, IVR methods, digital information seize, MS phrase and excel Potential to stability duties with competing priorities
Reveal determination making abilities Curiosity and keenness to study, innovate, capable of talk any potential dangers and get issues achieved
Pleasant, outgoing persona with the power to take care of a constructive angle below strain
Excessive degree of self-motivation and vitality
Potential to work independently in a fast-paced setting with minimal supervision
Will need to have a consumer service mentality
Expertise with supporting a number of websites and figuring out gaps
Expertise with inner and exterior audits: FDA, GCP, SOPs
Expertise with supporting a number of websites and figuring out gaps
Certifications/Licenses, Training, & Expertise:
2 years of expertise in High quality Assurance
4 years of expertise in Scientific Analysis
Advantages (US Full-Time Workers Solely)
PTO/trip days, sick days, holidays.
100% paid medical, dental, and imaginative and prescient Insurance coverage. 75% for dependents.
HSA plan
Quick-term incapacity, long-term incapacity, and life Insurance coverage.
Tradition of progress and equality
401k retirement plan
Variety & Inclusion
We serve sufferers and researchers from various cultures and communities around the globe. We’re stronger and higher after we construct a workforce representing the folks we intention to help. We preserve an inclusive tradition the place folks from a broad vary of backgrounds really feel valued and revered as they contribute to our mission. We worth variety and consider that distinctive contributions drive our success.
At Care Entry, every single day, we’re advancing medical breakthroughs. We’re uniting normal affected person care with cutting-edge remedies and analysis. Our work brings life-changing therapies to these in want and paves the best way for newer and larger remedies to succeed in the world. We’re proud to advance these breakthroughs and work with the large gamers whereas partaking with the perfect physicians and caring for sufferers. Our workforce of specialists is paving the best way to take this imaginative and prescient ahead by way of innovation and distinctive know-how enabled.
We’re an equal alternative employer, and all certified candidates will obtain consideration for employment with out regard to race, shade, faith, intercourse, sexual orientation, gender identification or expression, being pregnant, age, nationwide origin, incapacity standing, genetic info, protected veteran standing, or every other attribute protected by regulation.
Care Entry is presently unable to sponsor work.
