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Hlx Life Sciences
Boston, MA, United States
We are partnered with an innovative medical device business specialising in structural heart solutions. They are looking to hire a permanent CRA on the East Coast to manage daily site activities, for this first in class product. TAVR / TAVI, CRO management and class III device experience needed! Preference for qualified candidates based in the Bost
Job Source: Hlx Life SciencesAnteris Technologies Ltd
Boston, MA, United States
Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisb
Job Source: Anteris Technologies LtdMicrobot Medical
Boston, MA, United States
Job Title: Clinical Research Associate Reports To: Chief Medical Officer (CMO) Location: Boston, MA About Microbot Medical Microbot Medical is a dynamic, publicly traded, global, medical robotic device startup company. Microbot Medical develops robotic devices in the interventional endovascular space that provides doctors and surgeons with
Job Source: Microbot MedicalAllen Spolden
Boston, MA, United States
Job Description Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SO
Job Source: Allen SpoldenBRIOHEALTH SOLUTIONS INC
Boston, MA, United States
Job Description Job Description BrioHealth Solutions is looking to add to our growing team. We are looking for Clinical Research Associates(CRA) who are looking to help bring our novel LVAS device to the market. The ideal candidate will be well versed in clinical trial management, where you will be helping manage the data collected
Job Source: BRIOHEALTH SOLUTIONS INCPhilips
Cambridge, MA, United States
Job Title Senior Clinical Research Associate Job Description Your role: Acting as the Senior Clinical Research Associate for designated clinical studies, while providing leadership in the execution and management of clinical studies, to deliver high quality data to support Philips businesses. Ensuring the clinical studies are monitored and conduc
Job Source: PhilipsMapLight Therapeutics, Inc.
Burlington, MA, United States
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What Y
Job Source: MapLight Therapeutics, Inc.Tufts Medicine
Boston, MA, United States
We’re saving lives, building careers, and reimagining healthcare. We can’t wait to grow alongside you. Job Profile Summary This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and
Job Source: Tufts MedicineBoston, MA, United States
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
ABOUT ALIRA HEALTH
At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization; from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services.
Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.
Job Description
THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE
The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.
ESSENTIAL JOB FUNCTIONS*
•Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.
•Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
•Responds to sites' regulatory board requests for protocol and ICF clarification as needed
•Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment
•Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews
•Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites
•Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests
•Conducts remote review of data entered on electronic Case Report Forms (eCRFs)
•Works closely with field CRAs and data management to resolve queries on discrepant data
•Assists with efforts to recruit investigative sites to participate in clinical studies
•Complies with ICH GCP guidelines, FDA regulations, and company SOPs
•Participates in internal, client/sponsor, scientific, and other meetings as required
•Manages and resolves conflicting priorities to deliver on commitments
Performs additional duties as assigned
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
•BS/BA from an undergraduate program or equivalent experience
•1-2 years of experience in clinical research
•Proven ability to be careful, thorough, and detail-oriented
•Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
•Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
•Self-starter who thrives in a collaborative, yet less structured team environment
•Ability to problem-solve unstructured or ambiguous challenges
•Strong command of English, both written and verbal
•Excellent communication and interpersonal skills with customer service orientation
•Proficient with MS Office Suite, particularly Word and Excel Permanent authorization to work in the U.S.
WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.
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Email Alert for In-House Clinical Research Associate jobs in Boston, MA, United States
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