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

Clinical Studies Coordinator, Learning Health Systems

Under general supervision, responsible for the compilation and collection of dat...

Location

United States , Winston Salem

Salary:

24.10 - 36.15 USD / Hour

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

Bachelor's degree in a related field of study or an equivalent combination of experience and education
Experience in a medical and/or research setting
Paramedical or other clinical experience
Registered Record Administrator preferred
Understanding of medical and/or scientific terminology
Strong oral, written, and interpersonal communication skills

Job Responsibility

Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study
Assists in all aspects of the data collection process
Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee
Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals
Maintains appropriate patient records as necessary
Obtains and interprets pertinent data from medical records as needed
Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms
May supervise other personnel including volunteers as assigned
Assists in development of suitable codes and data collection forms for computerization
Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study

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
Opportunity for annual increases based on performance
Premium pay such as shift, on call, and more
Incentive pay for select positions

Fulltime

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

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

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

Animal Health Clinical Research Associate III

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

Location

United States , Shawnee

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

strong culture
great benefits
opportunity for growth

Fulltime

Clinical Research Coordinator

Investigators in the Division of Cancer Genetics and Prevention at the Dana-Farb...

Location

United States , Boston

Salary:

48100.00 - 54400.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor's degree required, with a focus in public health, social science, or natural science preferred
0-1 years of research experience required, with experience in a clinical or scientific setting strongly preferred
Effective in working independently and as part of a team
Comfortable with patient and clinical staff interaction and handling research specimens (e.g. saliva, blood, tissue, and/or urine)
Excellent interpersonal skills and the ability to communicate and relate effectively with diverse groups
Detail-oriented with excellent organizational, communication, problem-solving, and time management skills
Strong computer skills, including proficiency with Microsoft Office products, knowledge or ability to learn other systems such as Epic and REDCap
Competencies in study data entry and/or CRF completion, research study coordination, and regulatory requirements
Dependable, motivated, and willing to learn new processes and procedures as needed
Ability to approach projects in a responsible, thoughtful, and thorough manner

Job Responsibility

Responsible for participant recruitment, data reporting and management, collection of source documents, use and development of case report forms, adverse event reporting, filing and archiving of study records, and resolution of data queries
Interact with study participants as directed/required by the protocol and/or study team
Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits
Coordination and management of studies, including communication with regulatory authorities
Close-out of studies, including contributing to research articles, audit preparation, and communication with regulatory agencies
Facilitation of blood and tissue specimen collection processes, with potential travel needed to other local institutions via shuttle network

Fulltime

Operations Manager

The Operations Manager is a management position responsible for developing and i...

Location

United States , Friendswood

Salary:

Not provided

Aramark

Expiration Date

Until further notice

Requirements

Requires at least 3 to 5 years of culinary manager experience in a healthcare and/or senior living
Requires at least 3 to 5 years of experience in a management role
Bachelor's degree or equivalent experience preferred
Strong interpersonal skills
Ability to maintain effective client and customer rapport for mutually beneficial business relationships
Ability to demonstrate excellent customer service using Aramark's standard service model
Ability to maintain an effective working relationship with other departments to a unified food service experience for all customers
Requires occasional lifting, carrying, pushing, and pulling up to 50 lb.
Must be able to stand for extended periods of time
Must be a certified dietary manager, or a certified food service manager

Job Responsibility

Use Aramark's coaching model to engage and develop team members to their fullest potential
Reward and recognize employees
Ensure individual and team performance meets objectives and client expectations
Plan and lead daily team briefings
Ensure safety and sanitation standards in all operations
Identify client needs and communicate operational progress
Ensure the completion and maintenance of P&L statements
Deliver client and company financial targets
Adopt all Aramark processes and systems, understand performance metrics, data, order and inventory trends
educate teams on key levers to improve margins

Fulltime

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Peru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 5+ years of professional experience in clinical trial regulatory affairs
Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
Proficiency with Veeva Vault or similar document management system
Advanced written and spoken English proficiency
Strong regulatory strategy expertise in Peru and LATAM countries
Excellent verbal communication skills for presenting complex regulatory strategies to international clients
Client-focused approach with ability to understand and anticipate sponsor needs
Strong critical thinking and problem-solving abilities
Exceptional interpersonal and intercultural communication skills

Job Responsibility

Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
Keep project management tools current, including budget tracking and quality issue (QI) tools

Fulltime

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Clinical Studies Coordinator, Learning Health Systems

Job Description

Job Responsibility

Requirements

What we offer

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