Back to jobs
New

Medical Monitor Contractor

Remote

The ProKidney Medical Monitor is a licensed US based physician, preferably internist with knowledge of cardio-metabolic-renal diseases or trained nephrologist who oversees the safety, integrity, and compliance of clinical trials, ensuring that research is conducted in accordance with protocol, Good Clinical Practice (GCP), ethical standards, and regulatory requirements. 

 

Core Responsibilities 

  • Safety Oversight: Evaluate potential risks, review ongoing safety of trial participants, and assess adverse events (AEs) and serious adverse events (SAEs) for causality, severity, and collaborates as needed with PV teams. 
  • Protocol & Study Design: Provide medical expertise for protocol development, study design, and clinical study reports; align study objectives with best practices and patient safety priorities.  
  • Data Review: Analyze clinical data, lab results for screened and enrolled participants, and electronic data to detect early warning signs of safety issues or protocol deviations. Provides medical coding supervision.  
  • Regulatory Compliance: Ensure adherence to ICH-GCP, FDA/EMA guidelines, and institutional policies; participate in data safety monitoring boards and meetings as needed.  
  • Investigator and CRO Liaison: Serve as the additional point of contact for clinical investigators, and CRO medical monitors responding to protocol-related queries, and safety reporting.  
  • Decision-Making: Discusses at weekly medical monitors meetings or other study meetings data that pertains to the safety measures based on trial data.  
  • Reporting: reports into Clinical Development line function and presents during weekly MM meetings and discusses unclear or complex clinical trial data and potential deviations. 
  • Collaboration: Coordinate work with other team members in Clinical Development and Clinical Operations, CRAs to address potential protocol deviations, improve recruitment, and reduce noncompliance risks. Participates in the monthly medical and safety meetings within ProKidney and with the CRO. 
  • Workload: approximately 20 hours spread over week (about 4 hours daily). 

 

 

Skills & Qualifications 

  • Medical Education and Expertise: MD, licensed and board-eligible or preferably board-certified internist with a strong clinical background in the trial’s therapeutic area, or nephrologist with experience in cell therapy. Phase 3 industry trial medical monitoring experience required.
  • Regulatory Knowledge: Familiarity with GCP, FDA/EMA guidelines, and trial ethics. 
  • Analytical Skills: Ability to interpret complex clinical data and identify trends. 
  • Communication: Clear, professional communication with investigators, sponsors’ team members, and CRO medical teams. 
  • Documentation and use of electronic clinical study data: Meticulous record-keeping to support audits and inspections. Experience with MEDIDATA and/or other EDC systems used in clinical trials. 

 

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...

Street Address (with Apt/Suite/Unit #)
City, State, ZIP Code

Please note: We take your privacy very seriously. This information will not be shared and is used for internal purposes only.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in ProKidney’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.