Senior Clinical Research Associate jobs in United States
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ARTIDIS · 3 months ago

Senior Clinical Research Associate

positionHouston, TX
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

ARTIDIS is a clinical-stage health-tech start-up that has developed innovative nanotechnology for cancer diagnosis and treatment optimization. The Senior Clinical Research Associate (SCRA) will manage clinical studies, ensuring compliance with study protocols and Good Clinical Practice while working closely with various clinical teams to oversee monitoring activities and quality assurance.

Health CareMedical Device

Responsibilities

Monitors the conduct and progress of the study with focus on all quality related aspects of a study and acts as a main contact point for CRAs and CSMs
Trains and supports CRAs in all their duties as necessary
Provides quality assurance review of all study specific documents
Performs site audits, including source document review, as applicable
Assesses effectiveness of study processes and need for additional training of study teams
Performs periodic internal audits of the documentation of the Trial Master File and of the overall study conduct and compliance with the protocol and applicable regulations
Reviews contracts and budgets and ensures adherence to deliverables and timelines
Acts as a main line of communication between the internal ARTIDIS study team and the internal ARTIDIS Quality team

Qualification

Clinical study managementRegulatory guidelines knowledgeClinical Practice (GCP)Statistical applicationsClinical/health systems knowledgeTeam collaborationProblem-solvingOrganizational skillsCommunication skillsAttention to detailSelf-driven

Required

Bachelor's degree in a scientific discipline or related field required, or an equivalent combination of education and work experience
5+ years experience in conducting clinical studies, including both single-center and international multi-center studies
Thorough knowledge of regulatory guidelines and regulations and applicable GCP standards for medical devices
Knowledge of clinical/health systems and practices appropriate to the country/region where study-related activities are conducted
Skilled in the use of statistical, technical, and database computer applications
Self-driven and able to work effectively in a fast-paced environment with minimal supervision
Collaborative with a team-player attitude, pragmatic approach and creative problem-solving capabilities
Ability to thrive with minimal supervision
Strong organizational skills and an ability to multitask with a thorough attention to detail
Accountable and able to maintain a strong commitment to producing work of quality
Ability to communicate and interact competently and professionally at all levels within a broad, complex, clinical research environment
Excellent oral and written communication skills in English

Benefits

Competitive salary
Bonus for outstanding performance

Company

ARTIDIS

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ARTIDIS is committed to innovation and excellence in order to bring the future of health care to people.
dateFounded in 2017
location
Basel, Basel-Stadt, CHE
people-size51-200 employees
web-link
https://www.artidis.com/

Funding

Current Stage
Growth Stage
Total Funding
$42.43M
2023-05-31Series A· $27.03M
2021-08-31Debt Financing· $3.17M
2019-09-30Seed· $12.23M

Recent News

GlobeNewswire News Room
ARTIDIS announces publication demonstrating the nanomechanical signature of response to low-dose radiotherapy followed by CAR T cell therapy in solid tumors.
2024-11-08
Company data provided by crunchbase