Associate Clinical Research Associate
hace 1 mes
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are looking for an Associate Clinical Research Associate (Associate CRA) to join our team. With support of SrCRA/CRA and/or CRA Manager, this person will act as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
Responsibilities:
Develops strong site relationships and ensures continuity of site relationships through all
phases of the trial.
Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gains an in-depth understanding of the study protocol and related procedures.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o Subjects' right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Communicates with Investigators and site staff on issues related to protocol conduct,
recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identifies, assesses and resolves site performance, quality or compliance problems and
escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA
Manager, CRM, TA Head and CRD as needed.
Works in partnership with GCTO country operations, finance, regulatory affairs,
pharmacovigilance, legal and regional operations, HQ functional areas and externally with
vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
Manages and maintains information and documentation in CTMS, eTMF and various other
systems as appropriate and per timelines.
Supports audit/inspection activities as needed.
Performs co-monitoring where appropriate.
Requirements:
Bachelor's degree in science
Minimum 2 years of clinical research experience
Fluency in English (verbal and written) and excellent communication skills.
Ability to travel domestically.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices
Developing skills in Site Management including management of site performance and patient recruitment
Developing level of monitoring skill and independent professional judgement
Good IT skills
Works with high quality and compliance mindset
Capable of managing complex issues, solution -oriented approach
Ability to perform root cause analysis and implement preventative and corrective action.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:06/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
R295477
Tenemos otros empleos actuales relacionados con este campo que puede encontrar a continuación
-
Clinical Research Associate
hace 1 mes
San Blas-Canillejas, Madrid, España MSD A tiempo completoWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...
-
Oncology Outcomes Research Manager
hace 2 semanas
San Blas-Canillejas, Madrid, España MSD A tiempo completoThis position participates in defining the Market-Access proposal for products under their responsibility within the Market-Access Department and with the Business Unit. Occasional interaction with Health Technology Assessment (HTA) bodies assessing company products, to optimise the position of the company drug, building on the product's value proposition...
-
Oncology Outcomes Research Manager
hace 1 mes
San Blas-Canillejas, Madrid, España MSD A tiempo completoThis position participates in defining the Market-Access proposal for products under their responsibility within the Market-Access Department and with the Business Unit. Occasional interaction with Health Technology Assessment (HTA) bodies assessing company products, to optimise the position of the company drug, building on the product's value proposition...
-
Retail Stores Associate Ii
hace 2 semanas
San Blas-Canillejas, Madrid, España Nike A tiempo completoBecome a Part of the NIKE, Inc. TeamNIKE, Inc. does more than outfit the world's best athletes. It is a place to explore potential, obliterate boundaries and push out the edges of what can be. The company looks for people who can grow, think, dream and create. Its culture thrives by embracing diversity and rewarding imagination. The brand seeks achievers,...
-
Medical Science Liaison
hace 1 mes
San Blas-Canillejas, Madrid, España MSD A tiempo completoWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...
-
Medical Science Liaison
hace 2 semanas
San Blas-Canillejas, Madrid, España MSD A tiempo completoWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...
-
MSL Vacunas
hace 2 semanas
San Blas-Canillejas, Madrid, España MSD A tiempo completoJoin our global healthcare company and be part of the expansion of our Vaccines medical team in Spain We are seeking a dynamic and knowledgeable Field Based Medical Officer to join our team in Cataluña.As part of the Spanish medical team, the selected candidate will have the incredible opportunity to work on one of the most exciting projects in the...
-
Brand & Customer Manager HPV
hace 1 semana
San Blas-Canillejas, Madrid, España MSD A tiempo completoThe HPV Brand and Customer Manager is a member of the Vaccines Marketing team, reporting directly to the HPV Associate Director, who will:Develop brand strategy, based on ecosystem understanding, customer segmentation and prioritiesRepresent country customer and brand needs on internal local and global crossfunctional teamsThrough a focus on customers and on...
-
Product Manager Associate
hace 2 semanas
San Fernando de Henares, Madrid, España Medline Industries, Inc. A tiempo completoRole reports to: Product Manager (SPT & Proxima)Location: MadridContract: Permanent PurposeAs Product Specialist for the SPT & Proxima Division, in coordination with the Product Manager for the division, you will be responsible for researching, understanding and training the end users for Spain and Portugal, to drive your product categories' sales growth and...
-
Product Manager Associate
hace 2 semanas
San Fernando de Henares, Madrid, España Medline Europe A tiempo completoRole reports to: Product Manager (SPT & Proxima)Location: MadridContract: PermanentPurpose:As Product Specialist for the SPT & Proxima Division, in coordination with the Product Manager for the division, you will be responsible for researching, understanding and training the end users for Spain and Portugal, to drive your product categories' sales growth and...
-
Associate Director, ISC Cost to Win Leader
hace 2 semanas
San Agustín del Guadalix, Madrid, España BD A tiempo completoDescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.It takes the imagination and passion of all of us from design and engineering to the manufacturing and marketing of our billions of MedTech products per year to look at the...
-
Associate Director, ISC Cost to Win Leader
hace 2 semanas
San Agustín del Guadalix, Madrid, España BD A tiempo completoDescription We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to...
-
Hollister Co.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España Hollister Co. Stores A tiempo completodel empleoEl Trabajo Trabajo a jornada completa, se requiere disponibilidad horaria completaUn Key Holder de tiempo completo ayuda a impulsar el negocio a través del liderazgo y participa activamente para garantizar una experiencia de cliente diferenciada. Los Key Holders deben ser asertivos, analíticos y confiables como líderes de un negocio...
-
Hollister Co.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España abercrombie-fitch-co. A tiempo completoDescripción de la empresa Descripción de la empresa Abercrombie & Fitch Co. (NYSE: ANF) es una empresa líder y global del sector de Retail tanto de ropa como de accesorios para hombre, mujer y niño que engloba cinco marcas reconocidas. La icónica marca Abercrombie & Fitch fue fundada en 1892 y tiene como objetivo hacer que cada día sea tan...
-
Hollister CO.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España A & F A tiempo completode la empresaDescripción de la empresaAbercrombie & Fitch Co. (NYSE: ANF) es una empresa líder y global del sector de Retail tanto de ropa como de accesorios para hombre, mujer y niño que engloba cinco marcas reconocidas. La icónica marca Abercrombie & Fitch fue fundada en 1892 y tiene como objetivo hacer que cada día sea tan excepcional como el...
-
Hollister CO.
hace 1 mes
San Sebastián de los Reyes, Madrid, España A & F A tiempo completode la empresaDescripción de la empresaAbercrombie & Fitch Co. (NYSE: ANF) es una empresa líder y global del sector de Retail tanto de ropa como de accesorios para hombre, mujer y niño que engloba cinco marcas reconocidas. La icónica marca Abercrombie & Fitch fue fundada en 1892 y tiene como objetivo hacer que cada día sea tan excepcional como el...
-
Hollister Co.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España Hollister Co. Stores A tiempo completodel empleoEl rol de Assistant Manager es multifacético y fusiona la estrategia comercial, las operaciones, la creatividad y la gestión de personas. Estratégicamente, los assistant managers se responsabilizan de impulsar los resultados de ventas analizando el negocio y brindando la mejor atención al cliente. Se encargan de supervisar las operaciones...
-
HR Business Partner, Workforce Staffing
hace 1 semana
San Fernando de Henares, Madrid, España Amazon A tiempo completoWorkforce Staffing (WFS) leverages global infrastructure, technology, science and local insight to deliver scalable and sustainable associate hiring solutions. Our vision is to enable Amazon operations to operate with unconstrained capacity to deliver for customers. To achieve this, we're on an exciting transformation journey; implementing proprietary tech...
-
Hollister Co.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España abercrombie-fitch-co. A tiempo completoDescripción de la empresa Descripción de la empresa Abercrombie & Fitch Co. (NYSE: ANF) es una empresa líder y global del sector de Retail tanto de ropa como de accesorios para hombre, mujer y niño que engloba cinco marcas reconocidas. La icónica marca Abercrombie & Fitch fue fundada en 1892 y tiene como objetivo hacer que cada día sea tan...
-
Hollister Co.
hace 2 semanas
San Sebastián de los Reyes, Madrid, España Hollister Co. Stores A tiempo completode la empresa Descripción de la empresa Abercrombie & Fitch Co (NYSE:ANF) es una empresa líder y global del sector de Retail tanto de ropa como de accesorios para hombre, mujer y niño que engloba cinco marcas reconocidas. La icónica marca Abercrombie & Fitch fue fundada en 1892 y tiene como objetivo hacer que cada día sea tan excepcional como el...
