CRA (Level I)
hace 3 semanas
Essential Functions
· Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
· Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
· Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
· Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions ( Clinical Trial Management System).
· Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
· Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
· Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.
Qualifications:
Education and Experience:
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and
relevant formal academic / vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
Valid driver's license where applicable.
In some cases, an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
· Basic medical/therapeutic area knowledge and understanding of medical terminology
· Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and
procedural documents
· Good oral and written communication skills, with the ability to communicate effectively with medical
personnel
· Good interpersonal skills
· Ability to maintain customer focus through the utilization of good listening skills, attention to detail
and the ability to perceive customers’ underlying issues.
· Good organizational and time management skills
· Ability to remain flexible and adaptable in a wide range of scenarios
· Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth
investigation for appropriate root cause analysis and problem solving.
· Ability to manage Risk Based Monitoring concepts and processes
· Ability to work in a team or independently as required
-
Lead CRA.
hace 1 mes
Mexico City PSI A tiempo completoJob Description In the role of Lead Monitor, you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level. Only CVs in English will be considered. You will: Facilitate...
-
CRA - all levels
hace 1 mes
Mexico City Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Training Manager I
hace 3 semanas
Mexico City Concentrix A tiempo completoJob Title:Training Manager IJob DescriptionThe Training & Quality Manager To manage and facilitate, in a dynamic and passionate manner, the performance and deliverables of a client specific Training and Quality teams to exceed the expectations of the company and clients based in a continuous improvement of an effective and efficient operational delivery and...
-
Underwriter I
hace 1 mes
Mexico City Everest, Consultoría, Administración y Back Office S de RL de CV A tiempo completoDescription : Role Purpose: The primary purpose of this role is to partner in the development and execution of the Mexico Marine underwriting strategy and support the Active Underwriter and the wider underwriting community across Everest Global Markets in its delivery. Core Responsibilities: Underwrite and price Marine risks and...
-
Ctry Approval Assoc
hace 1 mes
Mexico City Thermo Fisher Scientific A tiempo completoEssential Functions and Other Job Information: Essential Functions • Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. • Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. • Coordinates, under...
-
Underwriter I
hace 1 mes
Mexico City Everest, Consultoría, Administración y Back Office S de RL de CV A tiempo completoDescription : Role Purpose: The primary purpose of this role is to partner in the development and execution of the Mexico Financial Lines underwriting strategy and support the Active Underwriter and the wider underwriting community across Everest Global Markets in its delivery. Core Responsibilities: Underwrite and price Financial Lines...
-
Ctry Approval Assoc
hace 3 semanas
Mexico City Thermo Fisher Scientific A tiempo completoJob DescriptionEssential Functions and Other Job Information: Essential Functions⢠Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. ⢠Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.â¢...
-
Program Manager
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global is seeking a Program Manager (PM) to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico. The PM shall be based in Mexico City, and shall have overall...
-
Business Leader
hace 7 días
Mexico City Ikea A tiempo completoJob description My goal is to establish the IKEA store as the first destination for furnishing businesses in my local market. I optimise IKEA BUSINESS sales and sustained profitability by actively working with the customer segment of business owners. IKEA BUSINESS is different from core-areas-of the-home, as it is not limited to a specific range area...
-
Gerente Asuntos Regulatorios
hace 3 semanas
Mexico City Nestlé A tiempo completoRegulatory & Scientific Affairs Jr Manager CMDXMain mission as a RSA Manager for Nestlé Mexico is to ensure functional leadership both internally and externally on specific regulatory topics through the development of Group’s positions and policies. You will also represent Nestlé in influencing activities with national authorities under the scope of the...
-
Credit Portfolio Analyst I
hace 2 semanas
Mexico City Citi A tiempo completoThe Credit Portfolio Analyst is an entry-level position responsible for participating in a variety of portfolio monitoring activities to identify credit migration in coordination with the Risk Management team. The overall objective of this role is to assist in managing Citi's portfolio exposure to clients and counterparties globally. Responsibilities: ...
-
Procurement Assistant
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking Procurement Assistant to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico.Responsibilities:The position is...
-
DevOps SRE
hace 1 mes
Mexico City Azka IT Consulting A tiempo completoAZKA IT is a Mexican company that seeks and connects the best IT talent with Latin American and United States companies.We are looking for your talent as DevOps Engineering (GCP)Requirements:SKILLS:-GCP experience involving design, deployment, configuration and optimization-Expertise in IAC development with Terraform -Experience with IAAS and PAAS...
-
Treaty Underwriting Coordinator I
hace 1 mes
Mexico City Swiss Re A tiempo completoPlease share your CV in English since this role will report to USA. ABOUT THE ROLE You would work closely with underwriting and everyone else on your team. This includes sometimes engaging with other functions like accounting, claims, legal and IT to exchange ideas and solve problems. You would also be responsible for overall business coordination of...
-
Senior Program Manager
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking Senior Program Manager to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico.Responsibilities:The position is...
-
Rule of Law Analyst
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking Rule of Law Analyst to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico.Responsibilities:The position is...
-
Anti-Gang Advisor
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking Anti-Gang Advisor to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico.Responsibilities:The position is located...
-
Medical Information Associate I
hace 4 días
Mexico City Thermo Fisher Scientific A tiempo completoWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make...
-
Anti-Money Laundering Advisor
hace 1 mes
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking an Anti-Money Laundering Advisor to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to Mexico.Responsibilities:The...
-
Mexico City SGI Global, LLC A tiempo completoSGI Global LLC is seeking fluent Spanish speaking Criminal Investigations Senior Program Analyst to support the Department of State, Bureau of International Narcotics and Law Enforcement Affairs (INL) in Mexico City, Mexico, which requires professional and administrative support services to work with the U.S. Foreign Assistance Program to...