Lead Clinical Research Associate

Psi CRO Ag; Bogotá; Presencial; COP 214.102.198 - 285.469.597; Jornada completa

Descripción de la vacante

Psi CRO Ag seeks a skilled Lead Monitor in Bogotá, Colombia, to oversee clinical project timelines and manage site feasibility processes. The ideal candidate has at least 4 years of site monitoring experience with a strong focus on oncology and compliance with US regulatory guidelines.

This role entails coordinating safety information flow, conducting site visits, and ensuring data integrity. The position requires excellent communication skills and the ability to travel up to 65%. Full proficiency in English is mandatory.

Formación

• Minimum of 4 years’ site monitoring experience with participation in global clinical projects.
• Must have experience monitoring or managing sites in the US with knowledge of US regulatory guidelines.
• Full working proficiency in English is required.

Responsabilidades

• Coordinates investigator/site feasibility and identification process.
• Monitors project timelines and patient enrollment.
• Conducts initial training and mentoring for newly promoted Lead CRAs.

Conocimientos

Oncology

Monitoring experience

MS Office proficiency

Excellent communication

Collaboration

Problem-solving

Educación

MD, MPharm, RN or equivalent degree

Descripción del empleo

Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits.
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as providesstatus updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 4years’ site monitoring experience with participationin global clinical projects as a Lead Monitor or equivalentqualificationlevel.
• Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
• Experience with all types of monitoring visits in Phases I-III.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).