Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients’ safety and well-being.

Home-Based in Mexico

Responsibilities:

• Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
• Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
• Monitors trial participant safety
• Participates in trial participant recruitment boost and retention activities
• Presents on medical matters at kick-off and investigator meetings
• Trains trial team in the therapeutic area and medical aspects of the protocol
• Develops and reviews trial-specific documents within the scope of medical monitoring
• Manages ongoing trial risks related to medical monitoring
• Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
• Reviews protocol deviations
• Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
• Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
• Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
• Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
• Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)
• Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
• Prepares for and participates in trial audits, follows up on audit findings
• Participates in feasibility assessment of potential and ongoing trials in the country/region
• Participates in bid defense meetings and other interactions with clients
• Acts as a medical expert and provides therapeutic expertise to other PSI departments

Qualifications

• Medical Doctor degree required
• Experience as a practicing Gastroenterology (minimum of 10 years)
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

Additional Information

As part of PSI’s Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

OverviewDane Street is seeking experienced Neurological Surgeons (Neurosurgeons) licensed in Mississippi to join our growing team of independent physician reviewers.

Allara is a comprehensive women’s health provider that specializes in expert, longitudinal care that supports women through every life stage.

Allara is a comprehensive women’s health provider that specializes in expert, longitudinal care that supports women through every life stage.

Allara is a comprehensive women’s health provider that specializes in expert, longitudinal care that supports women through every life stage.

Two Chairs is building a new kind of mental health system based on the idea that the status quo isn’t good enough. Industry-best clinician experiences, better client outcomes, groundbreaking innovation,...

We are seeking Board-Certified PMHNPs who prioritize clinical excellence over corporate metrics. We provide the infrastructure (secure EMR, patient marketing, and billing support) so you can run your remote practice with total autonomy.The Financial Ad...

Remuneration:

€82.50 - €102.50 per hour sessional

Are you looking for a new challenge?

Do you want more balance? More freedom? Hours that fit your lifestyle?

We're looking for GPs to join us, working remotely across the Republic of Ireland, to deliver the future of healthcare. If you are on the IMC SPECIALIST Register, maintain Professional Competence with the ICGP and have a minimum of 2 years post-training experience (at any time) within the Irish Healthcare system, we want to hear from you!

Who are we?

At HealthHero we bring human expertise and digital convenience together to deliver digital-first, integrated care that is revolutionising the healthcare industry. We know that people's healthcare needs cannot be constrained by 9-5 working hours, and nor should their clinicians be. As the leading provider of remote GP advice services in the UK and ROI, our services are accessible to over eight million patients and across the group.

Requirements

You will need to be resident within ROI.

Benefits

What do we do and where do you fit in?

In the ROI we work with private clients, and you'll be offering episodic non-emergency care to patients with private health insurance or employees of a client company, via remote appointments.

Job SummaryAptive Resources is seeking board-certified electrophysiologists and cardiologists to join our team in supporting patients with heart conditions.

Allara is a comprehensive women’s health provider that specializes in expert, longitudinal care that supports women through every life stage.

DescriptionFlexible Independent Contractor (1099) Require a DC or Maryland State Medical LicenseABOUT MRIoAFounded in 1983, Medical Review Institute of America (MRIoA) is a nationally recognized Independent Review Organization (IRO) specializing in technology-driven...