![MSD](https://www.energyjobline.com/sites/default/files/styles/squared_logo/public/job-logo/get-logo.php__476.png?itok=09u9T6Qc)
Associate Clinical Research Associate
4 settimane fa
Job Description
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 Ass. Clinical Research Associate to join our Clinical Research Monitor Team.
With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
- 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: Data generated at site are complete, accurate and unbiased; 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
- 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.
Experience Requirements:
- Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
Educational Requirements:
- B.A./B.S. with strong emphasis in science and/or biology
CORE Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- 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 CRA 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 judgment.
- Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- 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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
RemoteShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/31/2024*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.
Job Posting End Date:05/31/2024
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.
Requisition ID:R295842
-
Associate Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoThe role of Associate Clinical Research Associate support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our...
-
Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia Worldwide Clinical Trials A tempo pienoRequisition Number6194Employment Type:RegularWho we areWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are...
-
Clinical Research Associate
1 mese fa
Roma, Lazio, Italia MSD A tempo pienoThe Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...
-
Clinical Research Associate
3 settimane fa
Roma, Lazio, Italia MSD A tempo pienoThe Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...
-
Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoThe Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...
-
Sr. Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia Cmed A tempo pienoThe Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India.The CRO occupies a unique position in the clinical...
-
Clinical Research Associate Ii
4 giorni fa
Roma, Lazio, Italia Sitero LLC A tempo pienoSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...
-
Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoJob Description:The role is accountable for performance and compliance for assigned protocols and sites in acountry.Under the oversight of the CRA manager the person ensures compliance of study conduct withICH/GCP and country regulations, policies and procedures, quality standards andadverse event reporting requirements internally and externally.Acts as...
-
Associate Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities...
-
Associate Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoJob Description:With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site...
-
Senior Clinical Research Associate
1 mese fa
Roma, Lazio, Italia MSD A tempo pienoJob DescriptionWe aim to establish ourselves as the leading research-focused pharmaceutical company globally. Our dedication to improving healthcare accessibility is evident through our extensive policies, programs, and partnerships. At the forefront of combating diseases that affect both humans and animals, including cancer, HIV, Ebola, and emerging animal...
-
Sr. Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoJob Description:The role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally...
-
Associate Clinical Research Associate
4 giorni fa
Roma, Lazio, Italia Merck Sharp & Dohme (MSD) A tempo pienoJob DescriptionWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site...
-
Postdoctoral Research Associate
3 settimane fa
Roma, Lazio, Italia University of Liverpool A tempo pienoFollowing a successful grant application to the UK Arts and Humanities Research Council we are seeking to recruit one 60% FTE (i.e. 3 days per week) Postdoctoral Research Associate, for a 9-month fixed period, based in Rome, Italy.The Project entitled The Other Rome: Centring People and Spaces of Maintenance is a collaboration between the Liverpool School of...
-
Postdoctoral Research Associate
2 mesi fa
Roma, Lazio, Italia University of Liverpool A tempo pienoFollowing a successful grant application to the UK Arts and Humanities Research Council we are seeking to recruit one 60% FTE (i.e. 3 days per week) Postdoctoral Research Associate, for a 9-month fixed period, based in Rome, Italy.The Project entitled The Other Rome: Centring People and Spaces of Maintenance is a collaboration between the Liverpool School of...
-
Associate Director
4 giorni fa
Roma, Lazio, Italia FactSet Research Systems, Inc. A tempo pienoFactSet Research Systems, Inc. Associate Director New York , New York Apply Now Associate Director, Performance & Reporting Engineering, FactSet Research Systems Inc, New York, NY:Manage a team of engineers and projects within the Performance & Reporting Engineering department. Coordinate with Engineering and Product Development leadership to define goals...
-
Associate Clinical Operations Manager I
4 giorni fa
Roma, Lazio, Italia MSD A tempo pienoThese roles are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
-
Associate Director, Project Management
4 giorni fa
Roma, Lazio, Italia Worldwide Clinical Trials A tempo pienoRequisition Number6259Employment Type:RegularSUMMARY: The Associate Director, Project Management (ADPM) will provide support and oversight of large, multi-national projects, responsible for directing large national or global projects or a program of projects, and/or complex projects in terms of customer/deliverables, providing functional leadership to PMs....
-
Clinical Research Associate Ii Rome
4 giorni fa
Roma, Lazio, Italia Resourcing Life Science A tempo pienoCompany DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a CRA home based in Rome.Job Overview Monitoring clinical studies in phases II-III Assuring...
-
Associate
4 giorni fa
Roma, Lazio, Italia Confidenziale A tempo pienoPer noto studio legale internazionale, sede di Roma, siamo alla ricerca di un Associate con focus nel regulatory. Dettagli sul cliente Noto studio legale internazionale. Descrizione L'Associate riportando al Partner si occuper di regolamentare bancario. Profilodel Candidato La risorsa dovr essere in possesso dei seguenti requisiti:abilitazione forense 2/3...