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CRA Lead/CRM (Pregnancy Registry)

TFS


2 weeks ago

Job type: Full-time

Hiring from: USA Only

Category: Medical / Health


 

Key Responsibilities

Project oversight and responsibility over clinical operations deliverables

Responsible for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.

Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.

Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.

Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.

Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.

Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.

Perform co-monitoring visits as part of the monitoring team quality oversight.

Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.

Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.

Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.

Ensure documents remain current during the course of the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager.

When delegated by Project Manager, track and approve investigators payments.

Assist Project Manager in CRA training program, training CRAs on study procedures and requirements and ensuring a proper handover when there is a replacement of CRA.

When requested, support project Manager developing and distributing study updates and newsletters.

Review CTMS to ensure country, site and subject information is recorded properly and on a regular basis.

Provide input to project manager about activities time registration and consumption ensuring appropriate revenue recognition and revenue forecasting.

Participate in Investigators Meetings and present monitoring requirements and deliverables when requested.

Interact with CRAs Line Managers (in case they are not) to ensure the proper CRA study allocation and discuss performance issues if any to ensure a proper follow up and resolution plan.

May also be appointed as primary CRA in some sites and conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out).

Actively contribute to the organization and development of initiatives and processes to enhance the work at TFS.

For local studies, CRM may be assigned as Project Manager being in charge of customer liaison, project budget management, vendor selection and management and any other additional tasks described in Project Manager Job Description.

May participate in proposal and budget development for new business opportunities

May participate in bid defense meeting preparations in partnership with Business Development and Senior Operations staff

Requirements

Degree in clinical, science or health related field

4+ years of clinical research experience, preferably as CRA, including relevant on-site monitoring experience.

Experience in Pregnancy Registries

Able to work in a fast paced environment with changing priorities

Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas

Possess the understanding of Good Clinical Practice regulations, ICH guidelines

Ability to work independently as well as in a team matrix organization and multiple projects

Excellent written and verbal communication skills as well as computer skills

Excellent organizational and Line Management skills

 

Before you apply, please check if any restrictions apply in terms of time zone or country.

This job has a geo-restriction in place: USA Only.

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