Clinical Research Specialist II Job at University of Rochester (Rochester)

Medical Appeals/Grievance Specialist II - Registered Nurse

Responsible for utilizing clinical acumen and managed care expertise related to ...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

1 year experience in clinical and health insurance or other healthcare related field
3 years experience in clinical and health insurance or other healthcare related field AND 1 year Managed care experience with a focus in Utilization Management (UM), Prior Authorization (PA), Claims, Case Management and/or Medical Appeals and Grievance (MAG)
5 years experience in clinical and health insurance or other healthcare related field AND 2 years Managed care experience with a focus in Utilization Management (UM), Prior Authorization (PA), Claims, Case Management and/or Medical Appeals and Grievance (MAG)
8 years experience in clinical and health insurance or other healthcare related field AND 3 years above satisfactory job performance in the managed care environment with a focus in Utilization Management (UM), Prior Authorization (PA), Claims, Case Management and/or Medical Appeals and Grievance (MAG)
Associate’s Degree in a healthcare field of study or Nursing Diploma
Active, current, and unrestricted license to practice in the State of Arizona (a state in the United States) or a compact state as a Registered Nurse (RN), a Physical Therapist (PT) or a Licensed Master Social Worker LMSW.
Intermediate PC proficiency
Intermediate skill using office equipment, including copiers, fax machines, scanner and telephones
Maintain confidentiality and privacy
Advanced clinical knowledge

Job Responsibility

Perform in-depth analysis, clinical review and resolution of provider appeals/inquiries, corrected claims and subscriber reconsiderations, member appeals, corrected claims and provider grievances for all lines of business
Identify, research, process, resolve and respond to customer inquiries primarily through written / verbal communication.
Respond to a diverse and high volume of health insurance appeal related correspondence on a daily basis.
Analyze medical records and apply medical necessity criteria and benefit plan requirements to determine the appropriateness of appeal, grievance and reconsideration requests.
Maintain complete and accurate records per department policy.
Meet quality, quantity and timeliness standards to achieve individual and department performance goals as defined within the department guidelines and required by State, Federal and other accrediting organizations.
Demonstrate ability to apply plan policies and procedures effectively.
Consult and coordinate with various internal departments, external plans, providers, businesses, and government agencies to obtain information and ensure resolution of customer inquiries.
Attend staff and interdepartmental meetings.
Participate in continuing education and current developments in the fields of medicine and managed care.

Fulltime

Senior Clinical Research Associate II - FSP

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

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Site Specialist II

We are currently seeking a Site Specialist II to join our diverse and dynamic te...

Location

China , Shanghai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Minimum of 3 years of experience as a SSU
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment

Job Responsibility

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
Collaborating with investigators and site staff to facilitate smooth study conduct
Performing data review and resolution of queries to maintain high-quality clinical data
Contributing to the preparation and review of study documentation, including protocols and clinical study reports

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
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

New

Clinical Research Specialist II

We are seeking a time-as-reported (10 – 15 hours), bilingual (American Sign Lang...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Master's degree in psychology, social work, counseling, or related mental health field required
1 year of experience in clinical work or an equivalent combination of education and experience in clinical work with Deaf individuals required
Fluent in American Sign Language (ASL) and capable of adapting to the language needs of diverse Deaf individuals required
Experience working with the Deaf community required
Must maintain eligibility to participate in research involving human subjects by completing the Human Subjects Protection Program (HSPP) and NIH’s Good Clinical Practice training
Participation in available cultural competency training required

Job Responsibility

Conduct Deaf CBT-TS intervention sessions with Deaf participants assigned to the intervention group
Coordinate scheduling of intervention sessions with participants
Manage the study email account to appropriately respond to participant inquiries and schedule sessions
Utilize interpersonal skills, clinical knowledge, and clinical judgment to develop and maintain rapport
Utilize advanced Deaf cultural knowledge, ASL skills, and clinical judgment to effectively convey necessary information
Follow up with participants via email to provide them with a written Action Plan and resources
Apply advanced clinical reasoning to provide appropriate support, information, and access to services to participants in distress
Maintain security of study data and follow the study protocol for confidentiality
Present participation information at weekly meetings with the PI
Complete the Deaf CBT-TS training protocol

Parttime

Clinical Laboratory QC Specialist

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions...

Location

United States , Madison

Salary:

76000.00 - 125000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

All assigned job duties are performed following laboratory policies and procedures
Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data
Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified
May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends
May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports
Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members
Responsible for obtaining validation, verification, and study data for review
May be requested to assist in review of validation, verification, and study data
Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained
Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

Fulltime

New

Human subject research specialist ii

The Human Subject Research Specialist II will work across teams to 1) coordinate...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 2 years of experience in human subject coordination
Familiarity and comfort with Excel, ACESS, REDCap, and other databases
Transportation of biological samples to URMC labs
Community-facing experience, including communication with community stakeholders
Prior experience or comfort translating scientific concepts to general audiences
Prior experience with research studies conducting MRI and Phlebotomy assessments
Applicants must be trained, or willing to be trained to perform phlebotomy and assist with MRI scans
Strong written and verbal communication skills, especially with regard to interfacing with participants, individuals seeking services, community partners, and medical professionals
Prior training or interest in data management and/or statistics
Clean background check, valid driver’s license and reliable transportation

Job Responsibility

Coordinate a multi-tier perinatal health intervention program
Work on research studies at Mt. Hope Family Center to collect physiological and biological research data
Conduct research with families from diverse backgrounds
May include community-facing efforts
Occasional evenings and weekends required to accommodate participant’s schedules
Assists in implementing a universal perinatal prevention program
Conducts visit to ensure research participant adherence with protocol requirements, completes MRI and phlebotomy research assessments
Assists with documenting adverse events and reports to senior study staff, PI, Institutional Review Board (IRB), and/or any other required recipients or entities
Ensures all data are collected and secured within approved parameters and procedures
Includes providing transportation for subjects to attend research visits

Fulltime

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
Fluent in English

Job Responsibility

Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle
Supervises data input activities and provides impact analysis and report conclusions and recommendations
Identifies the need for new regulatory procedures and SOPs
Identifies requirements and potential obstacles for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities
Provides regulatory information and guidance for proposed product claims/labelling

What we offer

Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts

Fulltime

Utilization Management Nurse Specialist RN II

The Utilization Management Nurse Specialist RN II facilitates, coordinates, and ...

Location

United States , Los Angeles

Salary:

88854.00 - 142166.00 USD / Year

L.A. Care Health Plan

Expiration Date

Until further notice

Requirements

Associate's Degree in Nursing
At least 5 years of varied RN clinical experience in an acute hospital setting
At least 2 years of Utilization Management/Case Management experience in a hospital or HMO setting
Must be computer literate, with expertise in Outlook, Word, Excel, PowerPoint
Provision of excellent customer service required
Excellent time management and priority-setting skills
Maintains strict member confidentiality and complies with all HIPAA requirements
Strong verbal and written communication skills
Registered Nurse (RN) - Active, current and unrestricted California License

Job Responsibility

Facilitates, coordinates, and approves medically necessary referrals that meet established criteria
Assures timely and accurate determination and notification of referrals and reconsiderations
Generates approval, modification and denial communications
Actively monitors for admissions in any inpatient setting
Performs telephonic and/or onsite admission and concurrent review
Collaborates with onsite staff, physicians, providers, member/family to develop and implement a successful discharge plan
Works with the UM Manager and Physician Advisor on case reviews
Monitors and oversees the collection and transfer of data and referral requests by Providers
Acts as a department resource for medical service requests /referral management and processes
Receives incoming calls from providers, professionally handles complex calls

What we offer

Paid Time Off (PTO)
Tuition Reimbursement
Retirement Plans
Medical, Dental and Vision
Wellness Program
Volunteer Time Off (VTO)

Fulltime

Clinical Research Specialist II

University of Rochester

Location:
United States of America , Rochester

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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