Senior Cost Estimator - Mining Capex/Opex

Darwoft; Quilmes; On-site; ARS 1,800,000 - 2,400,000; Full time

Job summary

Darwoft is seeking a Senior Clinical Research Associate to lead site monitoring activities for multiple trials in Buenos Aires. You will ensure data integrity, compliance with GCP/ICH, and timely study milestones.

The role requires on-site monitoring, collaboration with cross-functional teams, and ability to travel as needed; strong organizational and communication skills are essential.

Qualifications

• Bachelor's degree in a health care or other scientific discipline.
• At least 4 years of on-site monitoring experience.
• Advanced English.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in CTMS and EDC systems.
• Willingness to travel as required.

Responsibilities

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
• Collaborating with colleagues and customers; knowledge of applicable clinical research regulatory requirements

Skills

On-site monitoring

GCP/ICH knowledge

Advanced English

CTMS proficiency

EDC proficiency

Travel willingness

Time management

Team collaboration

Education

Bachelor's degree in health care or scientific discipline

Tools

CTMS

EDC

Job description

Senior Clinical Research Associate

Buenos Aires, Argentina
Full time
R

The Senior Clinical Research Associate (CRA) will play a crucial role in the planning, execution, and management of clinical trials. This position requires a highly skilled and experienced professional who can ensure the integrity of clinical data, compliance with regulatory requirements, and the overall success of clinical research projects.

Responsibilities

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Comfortably collaborating and communicating with a variety of colleagues and customers. Ideally, have a good basic knowledge of applicable clinical research regulatory requirements

Requirements

• A Bachelor's degree in a health care or other scientific discipline or educational equivalent
• At least 4 years of on-site monitoring experience.
• Advanced in English.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel as required.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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