clinical research jobs canada remote

Clinical Research Associate I (Trial Monitor) - Remote

🔍 minneapolis, minnesota, united states.

POSITION SUMMARY:

 Please apply online using a laptop or desktop computer.

This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies. This position performs site monitoring visits to complete source document verification and assess site compliance. Additionally, this position is responsible for coordinating and providing support for all aspects of the study including protocol and site management.   This position can be remote (US) or hybrid.  #LI-Remote #LI-Hybrid 

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ACCOUNTABILITIES:  

Monitoring:

• Perform full-scope remote and on-site monitoring visits involving source document verification, review of essential regulatory documents, and assessing site performance. 
• Ensure compliance with clinical trial protocols based on regulations, ICH GCP guidelines, and NMDP standard operations procedures.
• Identify and communicate site findings with site study personnel and the study team.
• Perform query management activities and generate study and site status reports.
• With oversight and guidance, analyze trends in identified issues and author visit reports and letters. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action. 

Site Management:

• Oversee and manage operational aspects of clinical trial sites in conjunction with project teams.
• Assists with site activation and ensures study start-up and enrollment goals are met.
• Collect and review essential documents for investigational sites, including maintenance of electronic Trial Master File.
• Serves as primary liaison for site management issues for assigned studies, escalating to the clinical project manager as required. 
• Utilizes effective and proactive communication, relationship building, and issue management to develop and maintain good working relationships with Investigators and site staff.
• Provide support to Investigators, Study Coordinators, and other appropriate site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.

Centralized Monitoring:

• Assists in reviewing study site data and data reports to ensure timely and accurate submission and compliance with the study protocol.

Other duties as required for clinical operations:

• Performs all duties in compliance with standard operating procedures, regulations outlined in the Code of Federal Regulations (CFR), ICH GCP guidelines, Federal Drug Administration (FDA) guidance and other applicable Federal, state, and local laws. 
• Assist in user acceptance testing (UAT) of clinical database management system for individual clinical trials.
• Performs study tracking (e.g., CTMS, start-up, milestone, closeout); generates, reviews, and distributes management reports from internal tracking systems at requested intervals.
• Develops, maintains, and presents, in conjunction with senior staff, clinical trial and project specific training materials.  
• Assists study related problem-solving activities internally and at trial sites.
• Assists in protocol maintenance, tracking, and communications.
• Works with internal and external team members to deliver high quality trial execution.
• Participates in shared team responsibilities, ensuring optimal coverage of trials.
• Participates in NMDP, CIBMTR, or CIBMTR CRO Services project teams as needed.
• Complete and maintain all training requirements.
• Develop, maintain, and continuously improve study and site management processes, guidelines, tools, templates, best practices, and overall implementation.
• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Knowledge of:

• Clinical research study processes, study design, and protocol management.
• Medical terminology and anatomy/physiology.
• Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of internet.
• Training and conflict resolution skills.
• Time management skills and problem-solving abilities.

Ability to:

• Demonstrate excellent oral and written communication.
• Manage multiple deadlines and priorities while ensuring quality and timeliness.
• Perform tasks requiring excellent attention to detail. 
• Demonstrate independent problem-solving and decision-making for straightforward situations but requires guidance for complex situations.
• Analyze trends, identify issues, and escalate as appropriate.
• Adapt to change.
• Navigate processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently.
• Perform onsite visits. Expect to travel 50 - 70% of time (domestic and international) to sites, as necessary.
• Must exemplify our NMDP values in a highly professional manner in all settings.

Education and/or Experience:

• Bachelor’s degree in healthcare/science related field; however, upon evaluation, equivalent related experience and/or education may be substituted for the scientific or health-related degree requirement. 
• Minimum three years’ experience of conducting clinical research studies according to ICH GCP guidelines and/or verifying clinical data from medical records.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications.
• Direct experience working at research sites on clinical studies, with or without direct interaction with patients.
• ACRP or SOCRA certification.

DEI COMMITMENT: 

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.

 BENEFITS: NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave, and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information

• Number of Openings: 1
• Pay Basis: Yearly
• Schedule: Full-time
• Driver Policy: No
• Job Family: Research & Development
• Career Category: Professional
• Career Level: 5

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Research Billing Charge Review Analyst - Remote - 127813

Job description, #127813 research billing charge review analyst - remote.

UCSD Layoff from Career Appointment : Apply by 2/15/24 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants : Apply by 02/27/24. Eligible Special Selection clients should contact their Disability Counselor for assistance.

Candidates hired into this position may have the ability to work remotely.

DESCRIPTION

UC San Diego Health's Revenue Cycle department supports the organization's mission to deliver outstanding patient care and to create a healthier world - one life at a time. We are a diverse, patient-focused, high-performing team with a commitment to quality, collaboration, and continuous improvement that enables us to deliver the maximum standard of care to our patients. We offer challenging career opportunities in a fast-paced and innovative environment and we embrace individuals who demonstrate a deep passion for problem-solving and customer service.

The Clinical Research Charge Review Analyst will promote and facilitate a culture of financial solvency and compliance through accurate and timely clinical charge review (both technical and professional) for all study participants involved in clinical research activities at UCSD and includes mixed billed services(standard of care and research). This involves using research billing documentation< Epic EMR and/or Velos CTMS to support the clinical research revenue cycle. This includes, but is not limited to, comparing charges to the charge router, internal documentation and seeking concurrence from research staff and physicians to confirm accurate charge posting. Reviews clinical research protocols and determines whether the charges meet the necessary criteria for billing of routine costs to the patient/insurance.

Analyzes and interprets governmental and commercial payer guidelines in conjunction with the study documentation to determine the appropriate payer for each test/procedure required by the research protocol. Maintains up-to-date knowledge on Medicare, Medicaid, and other regulatory requirements pertaining to accepted coverage, billing, and reimbursement policies and standards. Reviews study documentation, medical records, and study coverage analysis grid to appropriately segregate research charges from charges billable to the patient/insurance once the patient visit has been completed and charges appear in the electronic health record billing system. Acts as an expert resource for preparation of claims for patients participating in research studies. Reviews protocol amendments to determine whether changes to the study billing grids will result in rebilling.

Facilitates change in the research revenue cycle process and related interfaces through communication with study teams, clinical departments, revenue integrity/charge description master, finance, information services, compliance, physician group and patient financial services to ensure the integrity and accuracy of medical records and hospital/physician bills.Communicates relevant governmental and commercial policy rules to study teams and appropriate service lines for reimbursement of coverage for services on research patients. Provides education, feedback, and clinical expertise to study teams and clinical departments to ensure consistency and accuracy in research charging and billing process. Collaborates with appropriate personnel to identify and remedy issues with particular studies and/or patient bills. Works with appropriate personnel to manage and appeal rejections/denials on clinical research patients. Incorporates knowledge gained from such activities to enhance front-end processes. Independently works on additional projects as requested.

MINIMUM QUALIFICATIONS

Seven (7) years of related experience, education/training, OR a Bachelor’s degree in related area plus three (3) years of related experience/training. Related experience: clinical research billing, research administration(grants and contracts) or research compliance.

Experience and proven success in billing and / or collections processes, concepts, systems and external regulations. Knowledge of medical terminology and coding

PREFERRED QUALIFICATIONS

HFMA Certified Revenue Cycle Representative (CRCR) highly desired.

AAPC or AHIMA coding certification highly desired.

Lean Six Sigma Green Belt or higher highly desired.

Two (2) years of work experience in healthcare finance (patient billing, collections, account reconciliations, etc.).

Knowledge and experience with aspects of third party reimbursement (Medicare, Blue Cross, Medicaid).

Working knowledge of medical terminology.

Demonstrated accuracy and precision, attention to detail, and exceptional organizational skills are essential.

Ability to interpret research protocol information highly.

Ability to manage large quantities of data in a manner which facilitates sharing of information.

Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines.

SPECIAL CONDITIONS

Must be able to work various hours and locations based on business needs.

Employment is subject to a criminal background check and pre-employment physical.

Pay Transparency Act

Annual Full Pay Range: $61,800 - $108,000 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $29.60 - $51.72

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, the only Burn Center in the county, and and dozens of outpatient clinics. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community .

UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20 For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Application Instructions

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Posted : 4/26/2024

Job Reference # : 127813

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