Top 92 Ibs research study Jobs

Lead Clinical Research Associate
PSI CRO —Remote
- Full-time
- Remote
- Medicine
- English
- Driver's License
Quick Apply
MEDICAL REVIEWER
Zenith LifeScience —South Plainfield, NJ
- $100,000 - $120,000 a year
- Full-time
- Medicine
- Microsoft Excel
- English
Research Fellow - Gut Microbiome Lab
Mayo Clinic —Rochester, MN
- $67,282.95 - $78,711.15 a year
- 8 hour shift
- Doctor of Philosophy
- US work authorization
- Senior level
- Health savings account
- Health insurance
Informed Consent Writer
ICON Plc —Blue Bell, PA
- Full-time
- Remote
- Microsoft Excel
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
6d
Director / Associate Director – Toxicology
Monte Rosa Therapeutics, Inc —Boston, MA
- $185,000 - $260,000 a year
- Full-time
- 5 years
- Master's degree
- Doctor of Philosophy
Associate Director, Clinical Science - Inflammation and Immunology
Arcus Biosciences —Remote
- $200,000 - $210,000 a year
- Full-time
- Remote
- Medicine
- 5 years
- Continuous improvement
Senior Scientist, Inflammation Biomarkers & Translational Research
Gilead Sciences —Foster City, CA
- $169,320 - $219,120 a year
- Full-time
- 5 years
- Office
- Doctor of Philosophy
- Health insurance
- Dental insurance
Principal Bioinformatician
Legend Biotech US —Somerset, NJ
- $146,410 - $192,164 a year
- Full-time
- Azure
- AWS
- Doctor of Philosophy
Quick Apply
Clinical Trial Manager, Immunology
SAB —Remote
- $150,000 - $165,000 a year
- Full-time
- Remote
- 6 years
- Bachelor of Science
- Bachelor's degree
Quick Apply
4d
Principal Research Associate/ Toxicology Study Coordinator
Ionis Pharmaceuticals, Inc. —Carlsbad, CA
- $110,847 - $142,160 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
Quick Apply
3d
Principal Regulatory Writer (Temporary)
Vir Biotechnology —Remote
- $180 - $200 a day
- Temporary
- Remote
- 11+ years
- Project management
- Bachelor's degree
Quick Apply
Manager, Clinical Pharmacology
ADLAI NORTYE USA INC —North Brunswick, NJ
- Full-time
- Microsoft Excel
- 3 years
- Business development experience
- Health insurance
- Dental insurance
Quick Apply
Director of the Institute of Behavioral Science (IBS)
University of Colorado Boulder —Boulder, CO
- $225,000 - $275,000 a year
- Full-time
- University
- Doctor of Philosophy
- Psychology
- Health insurance
- Dental insurance
5d
Associate Director, Safety Scientist
BeiGene —Remote
- $154,300 - $204,300 a year
- Full-time
- Medicine
- Computer literacy
- Databases
- Health savings account
- Employee stock purchase plan
Pathology Sr. Director
Amgen —Remote
- $249,288.85 - $337,273.15 a year
- Remote
- 5 years
- Master's degree
- Analysis skills
- Disability insurance
- Health insurance
Director, Safety Scientist
BeiGene —Remote
- $185,100 - $245,100 a year
- Full-time
- Medicine
- 6 years
- Computer literacy
- Health savings account
- Employee stock purchase plan
Senior Regulatory Writer (Temporary)
Vir Biotechnology —Remote
- $130 - $170 an hour
- Temporary
- Remote
- 7 years
- Bachelor's degree
- US work authorization
Quick Apply
Sub-Investigator - APRN/PA
Be Well Clinical Studies —Lincoln, NE
- $65 - $90 an hour
- Full-time
- Mid-level
- Quality control
- Older adults
Quick Apply
3d
Medical Director, Clinical Development
Deciphera Pharmaceuticals —Waltham, MA
- $243,300 - $334,590 a year
- Full-time
- Remote
- Medicine
- 8 years
- Business development experience
- Health insurance
- Dental insurance
Quick Apply
Clinical Scientist - Oncology - US - Remote
Worldwide Clinical Trials —Durham, NC
- Full-time
- Remote
- Continuous improvement
- Doctor of Philosophy
- Senior level

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Lead Clinical Research Associate

PSI CRO -
Remote

Quick Apply

Job Details

Full-time

Qualifications

Quality control corrective actions
Project reporting
Data integrity assurance
Doctor of Medicine
Medicine
Team supervision
Data validation techniques
Adverse event reporting
Clinical trial risk management
Clinical research audit management
Vendor coordination
Health information compliance monitoring
Quality control preventive actions
Corrective and preventive actions (CAPA)
English
Training material drafting
Project communication management
Radiation oncology
Clinical audit and monitoring
Team development
Data integrity and documentation
Driver's License
Research safety & compliance
Inventory reconciliation
Clinical training
Team training
Data quality monitoring
Clinical program monitoring
Quality compliance management
Managing clinical research teams

Full Job Description

Company Description

PSI is a leading Contract Research Organization with more than 25 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

As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams.

This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.

Responsibilities:

Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
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.
Collaborates with investigator/ site feasibility and identification process, as well as study startup.
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.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
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.
Delivers trainings and presentations at Investigator Meetings.
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 Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
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 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Experience with all types of monitoring visits in Phase II and/or III.
Strong experience in Oncology preferred.
Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, 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.
Valid driver’s license (if applicable).

For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Quick Apply

Refine Your Search

ibs research study jobs

Lead Clinical Research Associate

MEDICAL REVIEWER

Research Fellow - Gut Microbiome Lab

Informed Consent Writer

Director / Associate Director – Toxicology

Associate Director, Clinical Science - Inflammation and Immunology

Senior Scientist, Inflammation Biomarkers & Translational Research

Principal Bioinformatician

Clinical Trial Manager, Immunology

Principal Research Associate/ Toxicology Study Coordinator

Principal Regulatory Writer (Temporary)

Manager, Clinical Pharmacology

Director of the Institute of Behavioral Science (IBS)

Associate Director, Safety Scientist

Pathology Sr. Director

Director, Safety Scientist

Senior Regulatory Writer (Temporary)

Sub-Investigator - APRN/PA

Medical Director, Clinical Development

Clinical Scientist - Oncology - US - Remote

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