Job Description

Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study

Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conducting the clinical study throughout the study period.

Trains investigational site staff as necessary

When applicable, supports preparation of regulatory and / or EC submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials
• Full working proficiency in English and German
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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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 provides status 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 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Experience with all types of monitoring visits in Phase II and/or 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. 
• 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).

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Job Description

We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.

Only CVs in English will be considered
Home-based position in Mexico

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in Mexico
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Experience in Oncology or Infectious Diseases is a plus
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, deal with different tasks and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

As a CRA at PSI you will be involved in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

Office-based in Munich/Planegg or Home-based in Germany

You will:

• Conduct and report all types of onsite monitoring visits as well as remote visits.
• Perform CRF review, source document verification and query resolution.
• Be responsible for site communication and management.
• Be involved in site identification process.
• Assist in training of less expert CRAs, depending on your level of experience.

*Senior CRA can be assigned as Lead Monitor in some projects, while still partially monitoring.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience.
• Independent on-site monitoring experience in Germany.
• Independent experience in all types of monitoring visits in AMG studies, Phases II and/or III.
• Experience in Oncology, Hematology, Infectious / Rare / Gastro-intestinal Diseases is a plus.
• Full working proficiency in German, English and MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Communication, collaboration, and problem-solving skills.
• Ability to travel and valid driver’s license.

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Job Description

As a CRA at PSI you will be involved in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

Office-based in Munich/Planegg or Home-based in Germany

You will:

• Conduct and report all types of onsite monitoring visits as well as remote visits.
• Perform CRF review, source document verification and query resolution.
• Be responsible for site communication and management.
• Be involved in site identification process.
• Assist in training of less expert CRAs, depending on your level of experience.

*Senior CRA can be assigned as Lead Monitor in some projects, while still partially monitoring.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience.
• Independent on-site monitoring experience in Germany.
• Independent experience in all types of monitoring visits in AMG studies, Phases II and/or III.
• Experience in Oncology, Hematology, Infectious / Rare / Gastro-intestinal Diseases is a plus.
• Full working proficiency in German, English and MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Communication, collaboration, and problem-solving skills.
• Ability to travel and valid driver’s license.

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Job Description

In the role of Sr CRA II (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 regional projects as Lead Monitor and supervise study activities, timelines and schedules 
• Train Monitors in annotated monitoring visit reports
• Review monitoring reports and support monitors in their activities
• Act as the main communication line between Monitor and Regional Lead 
• Facilitate site budgets and contract negotiations
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress and lead project team calls on the country level 
• Participate in quality control and compliance monitoring
• May need to monitor and manage sites (if applicable)
• May need to supervise monitors on site
• Oversee and maintain study-specific and corporate tracking systems at site and country level

Qualifications

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• Participation in clinical projects as a Lead/Senior Monitor
• Independent on-site monitoring experience
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, leadership, and problem-solving skills
• Ability to travel

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