Clinical Studies Coordinator, Learning Health Systems Job at Advocate Health Care (Winston Salem)

New

Animal Health Clinical Research Associate

At Argenta, we’re more than a company — we’re a global team, dedicated to health...

Location

United States , Shawnee, Kansas

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

8+ years clinical trial monitor experience within a Clinical Research Organization or major Animal Health pharmaceutical company
proven experience in GCP late phase clinical trials in animal health
attention to detail and analytically driven
dependability, flexibility and ability to multitask and manage time effectively
Minimum of 8 years’ experience in an animal health research role, Monitor and Clinical Research Associate positions preferred
Experience in Good Clinical Practice (GCP) data management, quality control, and/or quality assurance preferred
Collaborative working style. Lead and motivate people through influence across all levels and functions of the organization
Ability to look for creative solutions to resolve complex issues
Strong technical writing ability
Results oriented and driven

Job Responsibility

Coordinates and conducts GCP and study protocol training at study sites and assures training is documented
Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities
Assists in reviewing the study records and all study notebooks to ensure contents are current and complete
Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits
Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies
Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol
Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation.
Serves as the liaison between Argenta US Clinical and study site personnel
Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel
Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor

What we offer

opportunity to work for a successful and rapidly expanding global business where your input will be valued
support our people through strong culture, great benefits, and opportunity for growth

Fulltime

New

Project Manager II, Learning Health Systems

Under administrative review, performs management level work directed toward the ...

Location

United States , Winston Salem

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health-related activities
or, an equivalent combination of education and experience
One-year experience in a supervisory capacity
Excellent oral and written communication skills
Demonstrates knowledge of scientific principles
Experience in both single- and multi-center studies

Job Responsibility

Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi-center study or multiple large studies
Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results
Negotiates protocol changes with funding agency/sponsor
Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi-center study or multiple studies including planning, development, implementation, and evaluation
Coordinates the hiring of and provides direction to support staff
Plans and coordinates training sessions for project personnel located at the different clinical sites
Oversees recruitment, data collection, and follow-up activities
Translates planning and design decisions into concrete activities and tasks for project implementation, and sets priorities for project implementation
Evaluates and interprets collected clinical data
Manages the preparation of progress reports and quality control monitoring

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

New

Project Manager II, Learning Health Systems

Under administrative review, performs management level work directed toward the ...

Location

United States , Winston Salem

Salary:

33.05 - 49.60 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health-related activities
or, an equivalent combination of education and experience
One-year experience in a supervisory capacity
Excellent oral and written communication skills
Demonstrates knowledge of scientific principles
Experience in both single- and multi-center studies

Job Responsibility

Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi-center study or multiple large studies
Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results. Negotiates protocol changes with funding agency/sponsor
Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi-center study or multiple studies including planning, development, implementation, and evaluation
Coordinates the hiring of and provides direction to support staff. Plans and coordinates training sessions for project personnel located at the different clinical sites. Oversees recruitment, data collection, and follow-up activities
Translates planning and design decisions into concrete activities and tasks for project implementation, and sets priorities for project implementation
Evaluates and interprets collected clinical data. Manages the preparation of progress reports and quality control monitoring
participate in the analysis of study data and the writing of scientific papers for publication
Develops data collection forms, procedural manuals, and other documents required for project implementation and evaluation
Ensures that all aspects of the following are completed: a. Study is conducted in accordance to the study protocol and contract b. Legal aspects adhere to state and federal regulations and guidelines c. Requirements of the Medical School and the University comply with the conduct of the study d. Technical requirements of the funding agency are met, including auditing requirements
Conducts site visits to evaluate staff and study activities. Coordinates sponsor audits

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

APEX Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States , Remote

Salary:

60000.00 - 70000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in life sciences/data sciences/pharmacy or other health related disciplines
6- 24 months maximum experience in clinical research
Strong interpersonal, written, and verbal communication skills within a matrixed team
Experience working in a self-driven capacity, with a sense of urgency and limited oversight
A client-focused approach to work and flexible attitude with respect to assignments/new learning
The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s)
An honest and ethical work approach to promote the development of life changing treatments for patients
Strong computer skills with aptitude to learn new systems quickly
Ability to travel 80% of the time
Rare Diseases or Oncology Study experience required

Job Responsibility

Act as an integral part to get treatments to patients sooner
Travel to investigator sites and perform monitoring duties
Build and maintain the site relationship and ensure they’re set up for success
Address and resolve site issues and questions
Manage site quality and delivery from site identification through to close-out
Perform billable project tasks to support the CRAs and Clinical Operations Leads (COLs) with a focus in three developmental areas: Project Support, Initiation CRA support, and Site Facing support
Complete the ACRP Entry Level Knowledge Assessment (CRKA)
Work closely with CRAs to gain exposure to and experience with the CRA role and its responsibilities across a period of four months
Apply in-class concepts with day-to-day application by working with clinical systems including Clinical Trial Management Systems (CTMS), Electronic Data Capture, Safety Information Systems, and TMF platforms
Accompany CRAs for observational and co-monitoring support on-site or during remote visits

What we offer

Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings
1-year membership to the ACRP
Training and development
Flexible work arrangements
Career growth and development programs

Fulltime

Associate Director of Operations

The Associate Director of Operations supports and oversees the daily operational...

Location

United States , New York

Salary:

79720.00 - 161199.00 USD / Year

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Bachelor's degree in public health/administration or business or a related field or equivalent education and experience
Masters (MPA, MPH, MBA or related) is preferred
5 years of experience in a professional business environment
health related and project management experience preferred
Supervisory experience is a plus
1 year in CRO, Pharma, Biotech or ARO preferred

Job Responsibility

Lead all administrative operations, managing a multidisciplinary team supporting clinical trials, registries, and translational research
Provide day-to-day supervision of the Clinical Trial Management Team, Administration Team, and Catheterization Laboratory Research Team
Assist the Director in daily departmental operations and provide professional and administrative guidance to staff
Evaluate operational performance and identify opportunities for improvement
advise and inform the Director of administrative issues, needs, and risks
Plan, organize, and implement services to meet departmental goals and objectives
Develop, implement, and refine departmental policies, procedures, and SOPs to ensure efficiency, quality, and regulatory compliance
Oversee hiring, supervision, mentoring, evaluation, and retention of administrative and research staff
Foster a culture of accountability, inclusivity, collaboration, and professional development
Participate in interviewing and recommending candidates

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

New

Peds Urology APP

Atrium Health is seeking a compassionate and motivated Advanced Practice Provide...

Location

United States , Charlotte

Salary:

47.50 - 71.25 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Demonstrates knowledge of etiologies, risk factors, pathophysiology, presentation and epidemiology of urologic conditions
Performs history and physical assessments of patients that are accurate, complete, concise, relevant and appropriate for age, gender and clinical problem
Orders appropriate diagnostic studies and correctly interprets the results
Utilizes critical thinking to synthesize and analyze collected data
Develops, implements, evaluates and alters the plan of care as needed
Manages general medical and surgical conditions based on knowledge of the indications, contraindications, side effects, interactions and adverse reactions of pharmacologic agents and other relevant treatment modalities
Counsels and educates patients and families
Demonstrates proficiency in procedural skills pertinent to practice area
Maintains accurate, complete, concise and timely documentation in the electronic medical record
Provides care that is patient and family centered, compassionate, appropriate and effective for the promotion of health, prevention of illness and treatment of disease throughout the lifespan

Job Responsibility

Functions as an independent healthcare provider who, working collaboratively with a multidisciplinary health team, is responsible for providing urologic care to both healthy and ill patients in the outpatient, and occasionally inpatient setting
Responsible for assessment, diagnosis, treatment, management, education, health promotion and care coordination for patients and families with acute and chronic health needs
Practices as a member of the Department of Urology provider team
Demonstrates an advanced level of medical/nursing clinical knowledge, communication and interdisciplinary collaboration, professionalism and systems-based practice
Works with administrative, nursing, physician, and faculty to assure safe, effective, quality patient care and to promote Atrium Health educational and research missions
Provide care within his/her scope of practice as outlined by applicable state law, licensing, regulations, institutional policy and practice agreements
Eligible to begin practice after he/she is credentialed and privileged by Atrium Health and Clinics Medical Staff
Active hospital privileges will be required to begin and to maintain employment within this Department
Will need to be credentialed and obtain and maintain professional privileges required for employment within this department

What we offer

$2,500 annual CME allowance and 5 CME days
Annual performance incentive bonus
Eligible for overtime, differential pay, and PTO with a competitive benefits package
Supportive work environment with excellent mentorship and collaborative care
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Clinical Studies Coordinator, Learning Health Systems

Advocate Health Care

Location:
United States , Winston Salem

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 14, 2026

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