No se aceptan más aplicaciones
Clinical Research Associate
Tigermed AmericaDenver, CO, USHace más de 30 días
Tipo de contrato
- Indefinido
Descripción del trabajoParticipates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically. Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB / EC) approval of study specific documents. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Trains site staff on the EDC system and verifies site computer system. Conducts periodic site file audits to ensure compliance with GCPs and company’s standard operating procedures. Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved company / sponsor forms and reports. Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. Reviews protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager. Serves as primary contact between the company and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. Assists with final data review and query resolution through database lock. Performs study close-out visits. Assists with, and attends, Investigator Meetings for assigned studies. May serve as mentor for new clinical study monitors. Authorized to request site audits for reasons of validity. Knowledge of clinical research process and medical terminology. Proven experience in monitoring and / or coordinating clinical trials preferred; experience in a clinical setting a plus. Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions. Strong organizational and interpersonal skills. Ability to reason independently and recommend specific solutions in clinical settings. Able to mentor entry level CRAs. Understand electronic data capture including basic data processing functions. Understand current GCP / ICH guidelines applicable to the conduct of clinical research Able to qualify for a major credit card. Valid driver’s license; ability to rent automobile. Willingness and ability to travel domestically and internationally, as required. BS / BA in one of the life sciences with proven experience of field monitoring experience. Computer literacy and knowledge of electronic data capture preferred. Must be able to travel domestically and internationally approximately 50%-75%. Language : English(required) Work authorization : United States(required)
Job Description
Job Description
An opening has become available for a SCRA or CRA to join one of the fastest growing CROs. We are currently looking for a Clinical Research Associate to join us. This position is permanent, home-based, can be located in Washington / Oregon / Colorado / Wyoming / Montana / Utah / Arizona / Idaho / Nevada / New Mexico .
Senior Clinical Research Associate Job Description :
As Clinical Research Associate you will be responsible for monitoring clinical trials and ensuring investigators are conducting the research within requirements of the clinical protocol. You will also make sure that :
- Research is conducted in accordance with applicable federal regulations / FDA guidelines
- Data quality on initial review meets acceptable clinical standards
- Rights and safety of human subjects involved in a clinical study are protected.
Responsibilities :
Further responsibilities of this Clinical Research Associate position include :
Qualifications, Skills and Experience :
To be considered for this Clinical Research Associate you will have the following qualifications, skills and experience :
We are an equal opportunity employer and value diversity
Crear una alerta de empleo para esta búsqueda
Clinical Research Associate • Denver, CO, US
Ofertas relacionadas
Clinical Research Associate II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerat...Mostrar másÚltima actualización: hace más de 30 días
The Clinical Research Regulatory Specialist is responsible for the management of clinical research protocol documents and activity from initial submission through study closure.The primary focus is...Mostrar másÚltima actualización: hace más de 30 días
University of Colorado Anschutz Medical Campus.Department : Linda Crnic Institution for Down Syndrome.Job Title : Research Associate.
The Linda Crnic Institute for Down Syndrome has an opening for a ...Mostrar másÚltima actualización: hace más de 30 días Clinical Research Associate II / Sr CRA - Full Service - ONC + Gen Med (Home-Based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accel...Mostrar másÚltima actualización: hace más de 30 días 
Seeking a Clinical Research Coordinator in Englewood, CO.Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH.
International Conference on Harmonization), ...Mostrar másÚltima actualización: hace 22 días
We are looking for an experienced Associate Director of Operations to join our team!.Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while pro...Mostrar másÚltima actualización: hace más de 30 días
The In Vitro Biology group of Inotiv Boulder is focused on biomarker analysis to help our clients better understand the effects of therapeutics in a wide array of disease models.Our specialty lies ...Mostrar másÚltima actualización: hace más de 30 días
At Intuitive, we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pio...Mostrar másÚltima actualización: hace 17 horas University of Colorado Anschutz Medical Campus.Sie Center for Down Syndrome, Children's Hospital Colorado.Clinical Research Professional.
Established in 2010, the Anna and John J.Sie Center for Down...Mostrar másÚltima actualización: hace más de 30 días This internship is a unique professional learning opportunity for a college student enrolled in a scientific field degree program to get exposure to different aspects of clinical research managemen...Mostrar másÚltima actualización: hace más de 30 días Clinical Research Associate II / CRA I - Sponsor Dedicated - ONC + Gen Med (Home-based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to a...Mostrar másÚltima actualización: hace 7 días Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to a...Mostrar másÚltima actualización: hace 20 días 
IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring as well as experience monitoring in oncology.
IQVIA Biotech is a full-service CRO purpose-built to serve biotech ...Mostrar másÚltima actualización: hace 3 días University of Colorado Anschutz Medical Campus.Department : Barbara Davis Center for Diabetes.Clinical Research Postdoctoral Fellow.
Position #00640121 - Requisition #37855.A clinical and research po...Mostrar másÚltima actualización: hace más de 30 días 
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by ...Mostrar másÚltima actualización: hace 21 días
All the benefits and perks you need for you and your family : .Student Loan Repayment Program.Whole Person Wellbeing Resources.
Joining AdventHealth is about being part of something bigger.Its about b...Mostrar másÚltima actualización: hace 29 días University of Colorado Anschutz Medical Campus.Job Title : Clinical Research Coordinator (Open Rank).Position # : 00841612 - Requisition # : .
The Clinical Research Coordinator will work in the School o...Mostrar másÚltima actualización: hace más de 30 días 
The Regional Clinical Research Manager is responsible for the coordination and administration of clinical trials at 3-4 clinical research site locations within a designated region under the directi...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Clinical Research Associate II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Western US)
Syneos Health / inVentiv Health Commercial LLCDenver, CO, United StatesTeletrabajo
A tiempo completo
- Oferta promocionada
Clinical Research Regulatory Specialist
Children's Hospital ColoradoAurora, CO, United StatesA tiempo completo
- Oferta promocionada
Research Associate
University of Colorado Anschutz Medical CampusAurora, CO, United StatesA tiempo completo
- Oferta promocionada
Clinical Research Associate II / Sr CRA - Full Service - ONC + Gen Med (Home-Based in Western US)
Syneos Health / inVentiv Health Commercial LLCDenver, CO, United StatesTeletrabajo
Temporal
- Oferta promocionada
Clinical Research Coordinator- 246542
MedixEnglewood, CO, USA tiempo completo
- Oferta promocionada
Associate Director of Clinical Trial Operations
CPC Clinical ResearchAurora, CO, USA tiempo completo
- Oferta promocionada
Research Associate, In Vitro Biology
InotivBoulder, CO, United StatesA tiempo completo
- Oferta promocionada
- Nueva oferta
Clinical Territory Associate
IntuitiveDenver, CO, USA tiempo completo
- Oferta promocionada
Clinical Research Professional
University of Colorado Anschutz Medical CampusAurora, CO, United StatesA tiempo completo
- Oferta promocionada
Clinical Research Intern
CPC Clinical ResearchAurora, CO, USA tiempo completo
- Oferta promocionada
Clinical Research Associate II / CRA I - Sponsor Dedicated - ONC + Gen Med (Home-based in Western US)
Syneos Health / inVentiv Health Commercial LLCDenver, CO, United StatesTeletrabajo
Temporal
- Oferta promocionada
Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)
Syneos Health / inVentiv Health Commercial LLCDenver, CO, United StatesTeletrabajo
Temporal
- Oferta promocionada
CRA 2, Oncology, IQVIA Biotech
IQVIADenver, CO, United StatesA tiempo parcial
- Oferta promocionada
Clinical Research Postdoctoral Fellow
University of Colorado Anschutz Medical CampusAurora, CO, United StatesA tiempo completo
Associate Clinical Engineer
Zimmer BiometEnglewood, CO, United StatesA tiempo completo
- Oferta promocionada
RN Clinical Coordinator OR
AH Rocky MountainCastle Rock, CO, USA tiempo completo
- Oferta promocionada
Clinical Research Coordinator (Open Rank)
University of Colorado Anschutz Medical CampusAurora, CO, United StatesA tiempo completo
Regional Clinical Research Manager
Urology America, MSODenver, CO, USA tiempo completo
Quick Apply