Clinical Trial Manager
Clinical research associate job in Rochester, NY
Country Lead Monitor
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
What you will be doing
Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
Build and manage strong relationships with trial investigators and stakeholders.
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
Your Profile
University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Ability to travel up to 20%
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Salary Range
$110,520.00-$138,150.00
Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
Are you a current ICON Employee? Please click here to apply
Auto-ApplyClinical Trial Manager
Clinical research associate job in Rochester, NY
Country Lead Monitor
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
What you will be doing
Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
Build and manage strong relationships with trial investigators and stakeholders.
Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
Your Profile
University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Ability to travel up to 20%
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Salary Range
$110,520.00-$138,150.00
Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.
Are you a current ICON Employee? Please click here to apply
Auto-ApplySr Clinical Research Data Specialist
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
220 Hutchison Rd, Rochester, New York, United States of America, 14620
Opening:
Worker Subtype:
Regular
Time Type:
Time as Reported / Per Diem
Scheduled Weekly Hours:
As Scheduled
Department:
400094 Neurology - NMD M & D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 108 H
Compensation Range:
$24.91 - $34.87
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
GENERAL PURPOSE
Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data and is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
ESSENTIAL FUNCTIONS
Assists in conducting quality checks of data accuracy with data source records as assigned. Perform data entry and verification tasks. Provides custom programming, statistical analysis, reporting and presentation graphics. Prepare and transfer data for analysis.
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics. Adheres to defined application development life-cycle practices, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
Consults with user departments and sites to assess data preparation and management needs, program design and testing; package selection and use of systems, software and equipment. Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately. Answers a broad range of data clarifications for each study, ranging from simple to complex. Fields complex inquiries from investigational, site, and study staff pertaining to study data, in conjunction with leadership when appropriate. Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. Assists in audit preparation. Develops source data worksheets specific to each assigned study. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
Acts as a mentor to lower level staff. Provides general support and education to staff. Collaborates with leadership to develop and update training modules and educational opportunities specific to the data coordination team.
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
Other duties as assigned
MINIMUM EDUCATION & EXPERIENCE
Bachelor's degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
KNOWLEDGE, SKILLS AND ABILITIES
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
Commitment to the University's core values Required
Ability to work independently and/or in a collaborative environment Required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required
Strong interpersonal, communication, and organizational skills
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet Required
LICENSES AND CERTIFICATIONS
CCRC - Certified Clinical Research Coordinator Preferred
or CCRP - Certified Clinical Research Professional Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Auto-ApplyClinical Research Coordinator
Clinical research associate job in Rochester, NY
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Job description
We are seeking a full-time, experienced Clinical Research Coordinator. The Research Coordinator will facilitate all facets of Gastrointestinal clinical research studies.
Responsibilities
Administratively and clinically manage industry-sponsored clinical trials
Adhere to Research SOP's, Good Clinical Practices, and the study protocols
Participate actively in communication of status and results to senior management
Assist in training site personnel in regulatory, lab procedures, and general study-related training
Assist in patient recruitment by performing detailed chart reviews and patient interviews
Discuss study protocols with patients and verify the informed consent documentation
Review medical history of patients against Inclusion/Exclusion Criteria of studies
Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations
Schedule all patient research visits and procedures consistent with protocol requirements
Dispense study medication, collect vital signs and perform ECGs
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
Ensure the filing and maintenance of all regulatory documents
Schedule and prepare for monitor visits
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Maintain contact with clients and resolve any issues or questions for which the client made inquiries
Assist with Practice focus on improving patient satisfaction and the patient experience
Assist in preparing a brief monthly report on key indicators and issues
Qualifications
Medical Assistant or LPN required
Associates degree in a clinical or scientific-related discipline preferred
1+ years previous experience as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials experience preferred
Computer skills - Microsoft Word, Excel, PowerPoint, CTMS, EMR
Previous experience in a role of complex administration or project coordination
Effective communication skills to include written, verbal ,and presentation skills
Strong attention to detail and organizational, analytical, and problem-solving skills, an agile sense of prioritization and urgency
Collaborative mindset
Periodic local travel to other practice locations on an as-needed basis
Physical Requirements
Ability to stand and walk throughout the day
Prolonged periods of sitting and performing administrative duties, including the use of computers
Ability to bend, twist, stoop, and reach
Able to lift and carry supplies and equipment as needed (up to 15 pounds)
Schedule
8 hour shift
Monday to Friday
Experience
Phlebotomy: 1 year (Required)
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplySenior Clinical Research Specialist
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
601 Elmwood Ave, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400072 Pediatric Hospital Medicine
Work Shift:
UR - Day (United States of America)
Range:
UR URG 110
Compensation Range:
$60,431.00 - $84,603.00
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Manages multiple studies' day-to-day operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensures each study's integrity, and mentors less experienced staff. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to study protocol. Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities, and personnel.
**ESSENTIAL FUNCTIONS**
+ Coordinates enrollment of participants.
+ With minimal supervision, coordinates the implementation of multiple complex clinical research protocols.
+ Oversees and facilitates eligibility screening and study recruitment activities. Implements strategies to increase accrual and may perform second eligibility checks as delegated by leadership.
+ Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents for non-treatment trials.
+ Plans study timelines and schedules appointments and study visits.
+ Manages and organizes case report forms, source documents and research records.
+ Enters research data into data collection forms and/or study databases.
+ Assists in conducting quality checks for data accuracy with data source records as assigned.
+ Develops and implements strategies to promote adherence to cultural competency guidelines, meet participants' needs for language translation, health literacy, etc.
+ Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
+ Manages and coordinates multiple complex studies and study patients.
+ Maintains study continuity and coordinates study participants and research procedures.
+ Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
+ Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and projected timeline.
+ Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines.
+ Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences, protocol deviations.
+ Develops and implements preventive/corrective actions.
+ Assists in identifying and developing data collection tools.
+ Performs quality checks for data accuracy, reports, and follows-up with discrepancies.
+ Assists in safety and quality improvement efforts, minimizing risk/safety threats.
+ Prepares for and responds to internal and external audits.
+ Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments.
+ Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department SOPs.
+ Assists in training less experienced research personnel in research competencies, UR and department SOPs, and protocol specific training.
+ Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies.
+ Complies with Good Clinical Practice and the Code of Federal Regulations.
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
+ Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
+ Obtains and/or maintains clinical research certification.
+ Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
+ Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
+ Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
+ Maintains proficiency in UR-specific research software needed to manage clinical research protocols.
+ Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards.
+ Assists in helping others in same.
+ Participates in protocol-related training as required.
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Bachelor's degree and 3 years of relevant experience required
+ Or equivalent combination of education and experience
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Ability to effectively manage complex research protocols/procedures required
+ Fully adheres to applicable safety and/or infection control standards required
+ Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards preferred
+ Proficiency in managing multiple and competing priorities/demands preferred
+ Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
+ Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred
+ Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
+ Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
+ Possesses a high degree of self-motivation preferred
+ Recognized ability to function independently preferred
**LICENSES AND CERTIFICATIONS**
+ CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year required or
+ SOCRA - Certification In Clinical Research within 1 year required
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Part Time - Clinical Robot Associate - Rochester, NY
Clinical research associate job in Rochester, NY
Clinical Robot Associate - Part Time (3 8-Hour Shifts per week) (5am-1pm OR 1-9pm ET shifts available) - Rochester, NY
We envision a future powered by robots that work seamlessly with human teams. We build the artificial intelligence that enables service robots to collaborate with people and adapt to dynamic human environments. Join our mission-driven, venture-backed team as we build out our customer-facing operations arm.
As part of Diligent Robotics' founding operations team, you will uphold the highest standards for safe clinical use of robots in real-world hospital environments. Through excellent communication and documentation, you will work alongside the hospital staff and our engineering team while assisting a cutting-edge fleet of robots. As part of the founding team, you will help design and implement processes as the organization scales. Clinical Robot Associates will solve unexpected situations that might arise during a shift, and work effectively as a team to ensure exceptional results to our hospital partners.
This is a part-time, entry-level role at Diligent Robotics and will work 3 afternoon 8-hour shifts per week. We have openings on our 5am-1pm OR 1-9pm ET shifts. This position is located in Rochester, NY and you must be local to be considered. The position pays $20/hr.
This is not an engineering position and a background in robotics or engineering is not required. If you have ever been an outstanding customer service representative helping busy customers with their needs, you may be a great fit for the role.
Your responsibilities will include:
Monitoring and safely assisting mobile service robots in a hospital environment
Collecting data and troubleshooting in a variety of real-world situations, while simultaneously providing detailed and accurate feedback to our engineers
Prioritizing the customer experience, ensuring their expectations are always met or exceeded
Communicating with hospital staff and, occasionally, the public regarding robot operation
A good candidate would be, at minimum:
A high school graduate or possess a GED
Customer-service oriented: you are friendly, skilled in the art of de-escalation, and an able juggler of customer demands and company needs
An excellent written and verbal communicator: you convey information to internal stakeholders in phone calls and direct messenger
Organized: you can juggle and make progress on multiple tasks simultaneously
Self-sufficient: you get things done, learn what you don't know, and can make quick decisions independently, as circumstances require
Able to lift up to 40 pounds
Able to work varying shift times including nights and weekends and understanding that your schedule may shift as customer needs change over time
Willing to work during significant holidays: you understand that our customers (i.e. hospitals) don't shut down during the holidays and neither can our robots
Willing to be vendor credentialed: our customers have strict standards and employment will be dependent on obtaining vendor credentials, the process of which will include various immunizations, a background check, a drug screen, among other steps
The ideal candidate would be:
Extraverted: you can strike up a conversation with anyone and everyone loves your presence
Responsive and responsible: you commit to deadlines, err on the side of over-communication, and understand the challenges of working with some co-workers that may be remote.
Results-oriented: you're happy to observe and take notes on end users interacting with the robot all day if that's what it takes
Passionate about healthcare and technology coming together to help people
Formerly employed in the healthcare space: you have an insider understanding of the vernacular, organizational structure, and operational processes of hospitals
Passionate and clear-eyed when it comes to robots: you understand that there's a gap between technological reality and media-driven expectations and are excited about the opportunity to move the industry forward by whatever means necessary, even if it isn't glamorous
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Auto-ApplyAdmitting Clinical Coordinator
Clinical research associate job in Rochester, NY
***Highland Hospital is seeking a full time Admitting Clinical Coordinator. This is a Salaried position, working rotating shifts on Days, Evenings and Nights.** Facilitates timely admission of adult patients to Highland Hospital (HH). Using Clinical Judgment and experience, interacts collaboratively with physician/provider teams, staff from the Emergency Department, Inpatient and Ambulatory areas, Wilmont Cancer Center, Transfer Center, and Bed Management to ensure timely decision-making relative to disposition and care needs of people requiring inpatient placement. Using clinical judgment and reviewing care needs, assigns patients to appropriate unit(s). Discretionary skills, critical thinking, collaboration, and excellent communication are essential to function as a liaison between physicians/providers, charge nurses, CRA's, managers, directors, and Bed Management staff in order to facilitate the admission of acute care patients. The ACC RN assures internal and external customer satisfaction and promotes a positive image of Highland Hospital by providing customer-friendly service at all times. Professional demeanor and Highland ICARE values are evident in all interactions.
**SALARY RANGE:**
$77,220.15 - $93,600.00
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Auto req ID:**
17379BR
**Job Requirements:**
**Qualifications:**
Education: **Fulfilled the education requirements to be a licensed RN in NYS;** BSN preferred
Experience: **3-5 years recent acute care hospital or comparable experience**
License/Certification Required: **Valid, current NYS RN license**
Skills: Ability to work independently and as part of a team; Possesses excellent communication and critical thinking skills; Demonstrates strong interpersonal skills and customer service skills
**Employment Status:**
Full-Time
**Hours/Week:**
40
**Posting Title:**
Admitting Clinical Coordinator
**City:**
Rochester
**Work Shift:**
Evenings/Nights
**Area of Interest:**
Nurses
The Hospital is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law.
Assistant Maat Clinical Coordinator
Clinical research associate job in Rochester, NY
Full-time Description
The health services that became the Anthony L Jordan Health Corporation (Jordan Health) began more than 100 years ago, in 1904. As one of the first 5 Federally Qualified Health Centers (FQHC) established in the nation, its roots are steeped in service to those who face barriers to health and health care, meeting their need for comprehensive medical, dentistry, behavioral health, and community services. Starting in northeast Rochester, NY, Jordan Health has since expanded to become a network of primary care offices and health centers serving residents living in three quadrants of Rochester, NY and in Canandaigua, N.Y.
Jordan Health is now seeking an Assistant MAAT Clinic Coordinator who, under the guidance of the Chief of MAAT Clinic, is primarily responsible for pretreatment screenings, intake evaluations under the close supervision of Chief and working directly with the MAAT Clinic Coordinator.
If you want to apply your specialized experience and education in an environment where you can make a difference and significantly impact patients' quality of life, please consider our Assistant MAAT Clinic Coordinator opportunity.
The Assistant MAAT Clinic Coordinator will perform the following Clinical Duties as follows:
· Conduct pre-treatment telephone screenings to assess patient's appropriateness for buprenorphine treatment
· Conduct chemical dependency evaluation and intake appointments utilizing alcohol and drug abuse assessment tools
· Assist with communicating with Chemical Dependency and/or mental health counselors in conjunction with MAAT Clinic Coordinator
· Assist with facilitating CD and Mental Health referrals for treatment utilizing community resources with MAAT Clinic Coordinator
· Assist with overseeing treatment compliance along with MAAT Clinic Coordinator
· Assist with updating and maintaining the protocol for the program under the direction of the medical director along with MAAT coordinator.
· Participate in monthly MAAT meetings and assist MAAT coordinator and medical director in preparing for the meeting
· Assist with managing provider schedules and monitoring patient census to ensure compliance with treatment standards.
· Assist in working with staff including care management teams to ensure patient access to appropriate services.
Requirements
Required Qualifications:
EDUCATION AND EXPERIENCE REQUIRED: Credentialed Alcoholism and Substance abuse Counselor (CASAC) preferred, minimum 1 year experience in alcoholism and substance abuse, Bachelor's degree preferred. Willing to consider training in other disciplines with experience and interest in addiction
LICENSES AND CERTIFICATIONS: CASAC certification up to date including professional continuing education if applicable
SPECIAL SKILLS, KNOWLEDGE REQUIRED: Fluency in Spanish Preferred, Experience with Microsoft Office including Word and Excel is required. Having valid driver's license and a vehicle strongly preferred as position may require travel to 3 sites - all sites are within 5-10 minutes by car. Proficiency in MS Office Applications (Word, Access, Excel, Power Point, Outlook)
Salary Description $21.00-$21.42/HOURLY
Sr Clinical Research Data Specialist
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
220 Hutchison Rd, Rochester, New York, United States of America, 14620
**Opening:**
Worker Subtype:
Regular
Time Type:
Time as Reported / Per Diem
Scheduled Weekly Hours:
As Scheduled
Department:
400094 Neurology - NMD M & D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 108 H
Compensation Range:
$24.91 - $34.87
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data and is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
**ESSENTIAL FUNCTIONS**
+ Assists in conducting quality checks of data accuracy with data source records as assigned. Perform data entry and verification tasks. Provides custom programming, statistical analysis, reporting and presentation graphics. Prepare and transfer data for analysis.
+ Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics. Adheres to defined application development life-cycle practices, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
+ Consults with user departments and sites to assess data preparation and management needs, program design and testing; package selection and use of systems, software and equipment. Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
+ Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately. Answers a broad range of data clarifications for each study, ranging from simple to complex. Fields complex inquiries from investigational, site, and study staff pertaining to study data, in conjunction with leadership when appropriate. Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. Assists in audit preparation. Develops source data worksheets specific to each assigned study. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
+ Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
+ Acts as a mentor to lower level staff. Provides general support and education to staff. Collaborates with leadership to develop and update training modules and educational opportunities specific to the data coordination team.
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
Other duties as assigned
**MINIMUM EDUCATION & EXPERIENCE**
+ Bachelor's degree Required
+ 2 years of relevant experience Required
+ or equivalent combination of education and experience Required
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Skill in completing assignments accurately and with attention to detail Required
+ Ability to understand and follow standard research protocols and procedures Required
+ Ability to process and handle confidential information with discretion Required
+ Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
+ Commitment to the University's core values Required
+ Ability to work independently and/or in a collaborative environment Required
+ Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required
+ Strong interpersonal, communication, and organizational skills
+ Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet Required
**LICENSES AND CERTIFICATIONS**
+ CCRC - Certified Clinical Research Coordinator Preferred
+ or CCRP - Certified Clinical Research Professional Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Sr Clinical Research Data Specialist
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
220 Hutchison Rd, Rochester, New York, United States of America, 14620
Opening:
Worker Subtype:
Regular
Time Type:
Time as Reported / Per Diem
Scheduled Weekly Hours:
As Scheduled
Department:
400094 Neurology - NMD M & D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 108 H
Compensation Range:
$24.91 - $34.87
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
GENERAL PURPOSE
Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data and is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
ESSENTIAL FUNCTIONS
* Assists in conducting quality checks of data accuracy with data source records as assigned. Perform data entry and verification tasks. Provides custom programming, statistical analysis, reporting and presentation graphics. Prepare and transfer data for analysis.
* Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics. Adheres to defined application development life-cycle practices, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
* Consults with user departments and sites to assess data preparation and management needs, program design and testing; package selection and use of systems, software and equipment. Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
* Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately. Answers a broad range of data clarifications for each study, ranging from simple to complex. Fields complex inquiries from investigational, site, and study staff pertaining to study data, in conjunction with leadership when appropriate. Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. Assists in audit preparation. Develops source data worksheets specific to each assigned study. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
* Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
* Acts as a mentor to lower level staff. Provides general support and education to staff. Collaborates with leadership to develop and update training modules and educational opportunities specific to the data coordination team.
* Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
Other duties as assigned
MINIMUM EDUCATION & EXPERIENCE
* Bachelor's degree Required
* 2 years of relevant experience Required
* or equivalent combination of education and experience Required
KNOWLEDGE, SKILLS AND ABILITIES
* Skill in completing assignments accurately and with attention to detail Required
* Ability to understand and follow standard research protocols and procedures Required
* Ability to process and handle confidential information with discretion Required
* Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
* Commitment to the University's core values Required
* Ability to work independently and/or in a collaborative environment Required
* Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required
* Strong interpersonal, communication, and organizational skills
* Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet Required
LICENSES AND CERTIFICATIONS
* CCRC - Certified Clinical Research Coordinator Preferred
* or CCRP - Certified Clinical Research Professional Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Auto-ApplyClinical Research Data Specialist
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
10 Miracle Mile Dr, Rochester, New York, United States of America, 14623
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400911 Ctr Musculoskeletal Research
Work Shift:
UR - Day (United States of America)
Range:
UR URG 106 H
Compensation Range:
$21.36 - $29.90
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
Assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting. Answers simple data clarifications (i.e. data queries) for each study.
**ESSENTIAL FUNCTIONS**
+ Inspects clinical data and research data from electronic records and other sources and assists study staff on entering this data into electronic medium for each assigned study.
+ Supports the collection and analysis of research protocols and coordinates with the primary and sub-investigators.
+ Reviews all data submitted for accuracy and completeness and determines if any actions are required to resolve any errors, omissions or discrepancies.
+ Independently answers simple data clarifications and answers more complex data clarifications under guidance from management.
+ Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
+ Develops source data worksheets specific to each assigned study to ensure accurate source documentation.
+ Assists with the preparation and maintenance of electronic logs and data status updates to be presented routinely at PI Oversight meetings.
+ Investigates and reports on data collection into an electronic data capture system in a timely manner according to protocol guidelines and department standard operating procedures (SOPs).
+ Maintains screening, enrollment, and other sponsor and/or protocol specific logs, as required by protocol and department SOPs.
+ Works closely with the investigators and study personnel from all cross-functional teams to establish appropriate data collection methods to meet the needs for each assigned project.
+ Designs and creates data collection forms and communicates regularly with the study team to optimize data review and handling processes.
+ Ensures that appropriate quality assurance procedures are in place for error detection and correction.
+ Maintains currently knowledge and practice of all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
+ Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
+ Demonstrates accountability for continuous learning and participates in protocol-related training as required.
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Associate's degree and 1 year of relevant experience required
+ Bachelor's degree preferred
+ Or equivalent combination of education and experience
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Skill in completing assignments accurately and with attention to detail required
+ Ability to process and handle confidential information with discretion required
+ Commitment to the University's core values required
+ Ability to work independently and/or in a collaborative environment required
+ Understands and follows data integrity standards and processes required
+ Strong interpersonal, communication, and organizational skills required
+ Highly collaborative, works well in teams required
+ Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
+ Ability to understand and follow standard research protocols and procedures preferred
+ Knowledge of medical terminology preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Clinical Research Spec II
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
90 Crittenden Blvd, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400178 Cancer Center/Clin Trials Ofc
Work Shift:
UR - Day (United States of America)
Range:
UR URG 108 H
Compensation Range:
$24.91 - $34.87
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL SUMMARY
Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Assists in day-to-day operations and the implementation of clinical research protocols. Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. Assists in assuring the overall integrity of studies. Assists in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to approved protocols. Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.
**ESSENTIAL FUNCTIONS**
+ Coordinates enrollment of participants.
+ Manages and coordinates the enrollment of participants in moderate risk/moderately complex studies.
+ Participates in recruitment activities and performs screening and eligibility checks for potential study participants.
+ Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents to non-treatment trials.
+ Assists in planning study timelines and schedules appointments and study visits.
+ Manages and organizes case report forms, source documents, and research records.
+ Enters research data into data collection forms and/or study databases.
+ Assists in conducting quality checks for data accuracy with data source records as assigned.
+ Manages and coordinates studies that are of a moderate size and complexity.
+ Maintains study continuity and coordinates study participants and research procedures.
+ Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
+ Performs data collection and entry activities according to protocol requirements and established operational procedures and timelines.
+ Observes for deviations and takes action to minimize them.
+ Reports and documents deviations when they occur.
+ Identifies logistical challenges in protocol implementation with the research team, assisting in resolving challenges.
+ Performs quality checks for data accuracy, reports, and follows-up with discrepancies.
+ Assists in safety and quality improvement efforts, minimizing risk/safety threats.
+ Prepares for and responds to internal and external audits.
+ Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic, administrative personnel, and other departments.
+ Adheres to cultural competency guidelines.
+ Implements strategies to meet study participants' needs for language translation, health literacy, etc.
+ Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs).
+ Assists in identifying and developing data collection tools. Assists the data coordinator in data tasks.
+ Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
+ Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
+ Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
+ Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
+ Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards.
+ Assists in helping others in the same. Participates in protocol-related training as required.
+ Complies with Good Clinical Practice and the Code of Federal Regulations.
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
+ Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Bachelor's degree and 1 year of relevant experience required
+ Or equivalent combination of education and experience
KNOWLEDGE, SKILLS AND ABILITIES
+ Ability to understand, follow and coordinate standard research protocols and procedures required
+ Fully adheres to applicable safety and/or infection control standards required
+ Understands and follows data integrity standards and processes required
+ Strong interpersonal, communication, and organizational skills preferred
+ Highly collaborative, ability to work well in teams preferred
+ Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Clinical Research Spec II
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
90 Crittenden Blvd, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400123 Radiation Oncology M&D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 108 H
Compensation Range:
$24.91 - $34.87
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL SUMMARY
Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Assists in day-to-day operations and the implementation of clinical research protocols. Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. Assists in assuring the overall integrity of studies. Assists in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to approved protocols. Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.
**ESSENTIAL FUNCTIONS**
+ Coordinates enrollment of participants.
+ Manages and coordinates the enrollment of participants in moderate risk/moderately complex studies.
+ Participates in recruitment activities and performs screening and eligibility checks for potential study participants.
+ Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents to non-treatment trials.
+ Assists in planning study timelines and schedules appointments and study visits.
+ Manages and organizes case report forms, source documents, and research records.
+ Enters research data into data collection forms and/or study databases.
+ Assists in conducting quality checks for data accuracy with data source records as assigned.
+ Manages and coordinates studies that are of a moderate size and complexity.
+ Maintains study continuity and coordinates study participants and research procedures. Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Performs data collection and entry activities according to protocol requirements and established operational procedures and timelines.
+ Observes for deviations and takes action to minimize them.
+ Reports and documents deviations when they occur. Identifies logistical challenges in protocol implementation with the research team, assisting in resolving challenges. Performs quality checks for data accuracy, reports, and follows-up with discrepancies. Assists in safety and quality improvement efforts, minimizing risk/safety threats.
+ Prepares for and responds to internal and external audits.
+ Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic, administrative personnel, and other departments.
+ Adheres to cultural competency guidelines.
+ Implements strategies to meet study participants' needs for language translation, health literacy, etc.
+ Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs).
+ Assists in identifying and developing data collection tools.
+ Assists the data coordinator in data tasks.
+ Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
+ Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
+ Maintains CITI and Conflict of Interest (COI) certification and renewal as required.
+ Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
+ Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards.
+ Assists in helping others in the same.
+ Participates in protocol-related training as required.
+ Complies with Good Clinical Practice and the Code of Federal Regulations.
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
+ Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Bachelor's degree and 1 year of relevant experience required
+ Or equivalent combination of education and experience
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Coordinate standard research protocols and procedures required
+ Fully adheres to applicable safety and/or infection control standards required
+ Understands and follows data integrity standards and processes required
+ Strong interpersonal, communication, and organizational skills preferred
+ Highly collaborative, ability to work well in teams preferred
+ Proficient in MS Office (e.g
+ Ability to understand, follow and. Word, Excel, and PowerPoint), email, internet preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Research Coordinator - RN
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
601 Elmwood Ave, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400157 Anesthes & Periop Med Research
Work Shift:
UR - Day (United States of America)
Range:
UR URCC 214 H
Compensation Range:
$35.35 - $45.96
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
The Clinical Trials Research Nurse is a registered professional nurse responsible for coordinating and conducting clinical research studies involving human subjects in compliance with national regulations, Good Clinical Practice (GCP) guidelines, institutional policies, and sponsor protocols. This role supports Phase I-III clinical trials and ensures the safety, rights, and well-being of research participants while maintaining high standards of data integrity and regulatory compliance.
The Clinical Trials Research Nurse works collaboratively with principal investigators, research coordinators, sponsors, and multidisciplinary healthcare teams to facilitate study implementation, subject recruitment, clinical procedures, monitoring, and ongoing participant care.
**Key Responsibilities**
Clinical Research Operations - 40%
+ Direct participant care, protocol-required procedures, monitoring for adverse events, specimen collection, and clinical assessments.
+ Maintain accurate and complete source documentation in accordance with GCP and federal regulations (FDA, NIH, OHRP)
+ Perform quality assurance reviews to ensure consistency between source documents and case report forms (CRFs).
Participant Recruitment & Enrollment - 20%
+ Screening, informed consent, eligibility reviews, outreach, and participant education.
Regulatory Compliance & Documentation - 15%
+ Source documentation, AE/SAE reporting, audit preparation, and regulatory submissions.
Study Coordination & Quality Improvement - 10%
+ Team meetings, protocol adherence monitoring, workflow optimization, and performance improvement initiatives.
Administrative & Support Functions - 10%
+ Data entry, filing, scheduling, inventory control, and study material management.
Training & Professional Development - 5%
+ Sponsor training, GCP certification, and continuing education.
**Clinical Research Operations**
+ Conduct protocol-specific clinical procedures including venipuncture, ECGs, nasal swabs, urine collection, specimen processing, and vital sign monitoring.
+ Perform structured and unstructured interviews to assess subject eligibility, clinical status, and adverse reactions.
+ Monitor research participants for local and systemic reactions and document adverse events (AEs) and serious adverse events (SAEs).
+ Ensure timely reporting of AEs and SAEs to sponsors, Institutional Review Boards (IRBs), and regulatory authorities.
**Participant Recruitment & Enrollment**
+ * Identify potential subject pools through clinic settings, community outreach, and referral sources.
+ * Conduct screening and eligibility assessments via in-person and telephone evaluations.
+ * Obtain and document informed consent ensuring participant comprehension and voluntary participation.
+ * Provide ongoing education to participants and families regarding study requirements, risks, and benefits.
**Regulatory Compliance & Documentation**
+ Monitor for protocol deviations and implement corrective actions as needed.
+ Assist with audits and inspections by sponsors and regulatory authorities.
**Study Coordination & Quality Improvement**
+ Participate in study team and sponsor meetings throughout the trial lifecycle.
+ Collaborate with investigators and research staff to improve site performance and data quality.
+ Contribute to process improvement initiatives to enhance participant safety and study efficiency.
**Administrative & Support Functions**
+ Track participant visits and prepare compensation requests.
+ Manage inventory of study supplies and maintain organized exam and research areas.
+ Support data entry, filing, correspondence, and development of study-related documentation.
+ Assist with compiling study metrics and reports as required.
**National Standards & Compliance**
+ This position adheres to national and international clinical research regulations including: FDA Clinical Trial Regulations
+ Office for Human Research Protections (OHRP) guidelines
+ HIPAA privacy standards
+ Institutional Review Board (IRB) policies and procedures
**Qualifications**
+ Associate Degree in Nursing (ADN) required
+ Bachelor of Science in Nursing (BSN) preferred
+ Active Registered Nurse (RN) license in the practicing state and/or compact license
+ Minimum of 1 year clinical nursing experience; clinical trials experience preferred or a combination of education and experience
+ Proficiency in phlebotomy and adult patient care
+ Strong interpersonal, communication, and organizational skills
+ Competency in electronic medical records and research databases
**Preferred Skills and Competencies**
+ Knowledge of clinical research protocols and regulatory frameworks
+ Ability to work independently and manage multiple priorities
+ Strong critical thinking and problem-solving abilities
+ Attention to detail with high standards of accuracy
+ Experience with data collection and clinical documentation systems
**Physical & Work Environment Requirements**
+ Ability to perform clinical procedures and prolonged standing
+ Occasional travel to community clinics or medical facilities
+ Exposure to biological specimens and clinical environments
+ Ability to work under infection control and safety protocols
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Human Subject Research Coordinator 1
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
4901 Lac De Ville Blvd, Rochester, New York, United States of America, 14618
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400104 Neurology Movement Disorders
Work Shift:
UR - Day (United States of America)
Range:
UR URG 106 H
Compensation Range:
$21.36 - $29.90
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
Under the direct supervision of the Clinical Trial Manager with direction from the Principal Investigators,
coordinates all aspects of assigned human subject research studies involving Spanish-speaking patients. Typically, responsible for the successful coordination of observational and clinical drug trials. Provides assistance to the other research coordinators and Principal Investigators, works as an integral part of the research team.
**ESSENTIAL FUNCTIONS**
Recruits, consents, schedules, and conducts research subject visits for _observational studies_ (i.e., less complex studies involving minimal risk to subjects) in accordance with study protocol, coordinating these visits with the Principal Investigator.
+ Meets with Spanish-speaking patients interested in research after their clinical visit to discuss research opportunities
+ Recruits and consents subjects to assigned research studies.
+ Schedules and facilitates visits, performing study related procedures as outlined in protocol.
+ May perform testing such as cognitive function tests, depending on protocol.
+ Resolves questions and concerns received from study subjects, triaging to Principal Investigator as necessary.
+ Monitors study progress on a continuous basis.
+ Understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, following up and communicating as needed.
+ Assists Spanish-speaking patients with research visit appointment confirmation and transportation facilitation
Manages the regulatory details for assigned research studies and registries.
+ Prepares and/or maintains regulatory and study documentation, including study protocols, consent forms, logs, certifications, labs, IRB and sponsor documents, and applicable communication.
+ Manages and submits amendments and continuing reviews for IRB approval.
+ Ensures compliance with all applicable regulatory and institutional requirements and standards.
Trains with and assists other Human Subject Research Coordinators as directed on complex studies (i.e., industry-sponsored clinical drug trials involving greater risk to subjects).
+ Receives training and mentoring on conducting human subject research from HSRC II.
+ Provides support with study visits, regulatory compliance, and queries.
+ Assists with specimen processing and shipping.
+ Serves as back-up research coordinator in the absence of the HSRC II.
Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration.
+ Maintains continuous communication with all relevant stakeholders.
+ Resolves issues in a timely manner.
+ Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol.
+ Represents the University and Principal Investigator at study meetings as needed.
Develops and/or manages databases for research studies and registries.
+ Ensures data is entered in a timely manner, accurate, and database(s) is up-to-date.
+ Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved.
Demonstrates accountability for initial and ongoing learning related to clinical research studies.
+ Keeps current with study-specific training, including understanding of inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and report completion, adverse event reporting, and all relevant sponsor and institutional policies.
+ Attends training sessions and other educational opportunities related to clinical research in order to learn and keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas.
+ Attends division and research meetings
+ Attends and leads talks with community groups such as the Ibero-American Action League
+ Participates in Ibero's community advisory board
+ Partners with the Latino Health Coalition
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Bachelor's degree Required
+ OR Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee Program Required
+ Or equivalent combination of education and experience Required
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Fluent in the Spanish language (verbal & written) Preferred
+ Prior experience as a Phlebotomist Preferred
+ Word processing and data analysis software Preferred
+ Knowledge of word processing, spreadsheets, Red Cap and electronic data capture (EDC) software Preferred
+ Excellent communication skills, strong attention to detail, and strong interpersonal skills Preferred
+ Ability to work independently and as part of a team Preferred
**LICENSES AND CERTIFICATIONS**
+ Association of Clinical Research Professionals (ACRP) upon hire Preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Human Subject Research Coordinator I
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400087 Pediatrics M&D Inf Diseases
Work Shift:
UR - Rotating (United States of America)
Range:
UR URG 106 H
Compensation Range:
$21.36 - $29.90
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
Coordinates the activities associated with human subject research.
RESPONSIBILITIES:
- Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.
- Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment.
- Conducts visits to ensure research participant adherence with protocol requirements, such as taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. Ensures all data are collected and secured within approved parameters and procedures.
- Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures, and standards for documentation and communication. Under general direction from the Principal Investigator (PI), trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
- Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
- Acts as liaison with Sponsor's Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits).
- Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies. Makes recommendations and implements changes as appropriate.
QUALIFICATIONS:
- Bachelor's degree required
- 1 year of experience in human subject research coordination required
- or equivalent combination of education and experience required
- Word processing and data analysis software preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Auto-ApplyHuman Subject Research Coordinator Trainee- Part time
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
220 Hutchison Rd, Rochester, New York, United States of America, 14620
Opening:
Worker Subtype:
Regular
Time Type:
Part time
Scheduled Weekly Hours:
32
Department:
400010 Neuroscience
Work Shift:
UR - Day (United States of America)
Range:
UR URG 104 H
Compensation Range:
$18.65 - $26.11
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
GENERAL SUMMARY
The Human Subject Coordinator (HSRC) Trainee will assist with day-to-day implementation of the Adolescent Brain and Cognitive Development (ABCD) Study, a federally funded research study in the Cognitive Neurophysiology Lab. General protocol and directions are provided by a team of scientists at the ABCD Coordinating Center in San Diego, California. These protocols and directions are overseen by supervisory staff working at the Cognitive Neurophysiology Lab.
HSRC Trainee will assist with human subject consents for participation in neuroscience-related behavior and physiology research. This research will involve working with adolescents and their families but may also involve working with individuals with developmental disabilities, learning disorders, and diverse backgrounds. Under supervision, the HSRC Trainee will work with human subjects and carrying out study protocol.
The HSRC Trainee assists in subject consents and performing neurocognitive and psychological tests, as well as coordinating biologic sample collection. Study visits include conducting cognitive assessments, electronic surveys and interviews, collecting biological samples for genetic or drug testing, and guiding participants through MRI scans under supervision of a licensed technologist. The HSRC Trainee will utilize a variety of platforms for testing and data management, such as RedCap. All information, samples, and data that are collected must be stored and documented in accordance with IRB regulations.
Under supervision, the HSRC Trainee will be responsible for ensuring the comfort, privacy, and informed consent of human subjects during experimental procedures by explaining study information fully and following all protocols precisely. The HSRC Trainee will contribute to maintaining supplies and the cleanliness of the study.
ESSENTIAL FUNCTIONS
Plans and performs a variety of moderately complex laboratory tests including MRI and cognitive/behavioral assessments on an iPad.
Administers surveys and interviews research participants.
Ensures research participants' adherence to protocol requirements.
Assures proper setup and operation of specialized equipment.
Understands, reviews, and documents all aspects of approved protocols, procedures, and standards for documentation and communication.
Supports team members on the details of the protocol, including inclusion and exclusion criteria, informed consent procedures, and study activities.
Actively contributes to improving workflows, interacting with participants and parents.
Assists in other study based delegations and management.
Other duties as assigned.
MINIMUM EDUCATION & EXPERIENCE
Associate's degree required
Or equivalent combination of education and experience
Experience as a Phlebotomist preferred. No previous experience required
KNOWLEDGE, SKILLS AND ABILITIES
Excellent interpersonal and customer service skills preferred.
Strong organizational and communication skills, including written communication preferred.
Ability to collect observational data, attention to detail, and competence with lab equipment preferred.
Knowledge of word processing and other Microsoft Office tools, such as Excel preferred.
Knowledge with Google based tools, such as Google Sheets preferred.
Experience with data collection software (i.e. Redcap) preferred.
CERTIFICATIONS
CITI training certifications
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Auto-ApplyClinical Research Coordinator I
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
220 Hutchison Rd, Rochester, New York, United States of America, 14620
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
910088 Pediatrics Neonatology
Work Shift:
UR - Day (United States of America)
Range:
UR URG 102 H
Compensation Range:
$17.00 - $22.10
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
GENERAL SUMMARY
Assists with various activities associated with human subject research. Gains knowledge regarding clinical research procedures and protocols. Maintains logs and assists in entering research data into data collection forms and/or study databases.
ESSENTIAL FUNCTIONS
Assists with the administrative details required to conduct human subject research.
Works under supervision to learn and apply the details of standard protocols, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
Maintains all logs, including system data entry, according to all pre-established Standard Operating Procedures (SOPs).
Assists in entering research data into data collection forms and/or study databases.
Practices continuous learning in accordance with Good Clinical Practice (GCP) standards and guidelines.
Maintains requisite skills and completes mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Obtains and maintains various certifications applicable to the filed and/or assigned subject matters. Gains knowledge in medical research terminology.
Gains and practices proficiency in specific research software needed to manage clinical research protocols.
Keeps up to date with new developments in the field by reading related literature and studying relevant clinical standards.
May present/share these educational findings with other team members.
Participates in protocol-related training as required.
Complies with Good Clinical Practice and other applicable regulations.
Keeps current with all federal, state, sponsor, and institutional policies, laws, standard operating procedures, and guidelines.
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
Other duties as assigned.
MINIMUM EDUCATION & EXPERIENCE
High School diploma required
Associate's degree preferred
Or equivalent combination of education and experience
KNOWLEDGE, SKILLS AND ABILITIES
Ability to understand and follow simple research protocols and procedures preferred
Ability to adhere to applicable safety and/or infection control standards preferred
Ability to understand and follow data integrity standards and processes preferred
Strong interpersonal, communication, and organizational skills, and ability to work well in teams preferred
Proficiency in Microsoft Office Suite (e.g. Word, Excel, and PowerPoint), email, and internet preferred
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Auto-ApplyManager, Clinical Coordinator
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
**Job Location (Full Address):**
1860 South Ave, Floor 1 Reception, Rochester, New York, United States of America, 14620
**Opening:**
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
500125 Psychiatry SMH Child/Adoles
Work Shift:
UR - Day (United States of America)
Range:
UR URCB 212
Compensation Range:
$65,125.00 - $84,662.00
_The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations._
**Responsibilities:**
GENERAL PURPOSE
The Manager, Clinical Coordinator functions as the leader responsible for the clinical staff of all school-based satellite locations. There are currently 18 school-based satellites in the Greater Rochester area. The Manager, Clinical Coordinator provides clinical and administrative supervision to senior-level staff clinicians (e.g., Senior Mental Health Therapists), and they may provide clinical supervision to some non-senior staff clinicians. The position shares responsibility for clinical productivity and quality of care with the school-based clinicians. The Manager, Clinical Coordinator is the point person for urgent situations involving school-based staff, both during regular business hours and after business hours. They report to the Director/Chief of the Service and are essential to programmatic development, implementation, and evaluation of the school-based satellites. They collaborate in the development of policies and procedures and participate in the Department of Psychiatry Ambulatory Leaders Meeting. They spend a portion of their time as a primary therapist in one or more school-based satellite settings, providing behavioral health assessment, treatment planning, and treatment for patients with mental health diagnoses and their families, including providing crisis and risk management interventions, collaboration with collateral contacts, and coordination of linkages to necessary community resources. The Manager, Clinical Coordinator is the primary facilitator of the school-based satellite multidisciplinary treatment team meeting.
**ESSENTIAL FUNCTIONS**
+ The Manager, Clinical Coordinator provides oversight to ensure that staff clinicians located in school-based satellites meet all service standards (e.g., high-quality clinical care, productivity expectations, and timely completion of high-quality documentation).
+ They complete staff evaluations for direct report clinicians.
+ They serve as the point person for all performance issues, including overseeing Letters of Expectation and Letters of Written Warning.
+ Provides direct evidence-informed clinical treatment to assigned patients.
+ Assesses successful completion of therapeutic goals (i.e., progress monitoring) and plans patient discharge accordingly.
+ Independently performs complex psychosocial assessments and diagnostic formulations for patients and their families.
+ Meets minimum target for clinical productivity set by Ambulatory Chief.
+ Collaborates with referral sources and other professionals both internal and external throughout patient care activities (e.g., PCPs).
+ Mobilizes family and natural support networks when clinically indicated.
+ Documents treatment in patients' electronic medical record in compliance with regulations.
+ This includes the development of family-centered, comprehensive, and individualized treatment plans for patients with clearly defined therapeutic goals in collaboration with patients and families.
+ Provides clinical and administrative supervision to senior-level staff clinicians (e.g., Senior Mental Health Therapists).
+ Also, may provide clinical supervision to staff clinicians and trainees.
+ Shares responsibility for the quality of care being provided by the supervisee (e.g., shares knowledge of evidence-based assessment and interventions, community resources, models ethical behavior and standards, provides regular feedback on strengths and areas for growth, and communicates with other members of the supervisory team).
+ Provides daily consultation and support to clinical and support staff, faculty, and trainees as necessary.
+ Responds to urgent situations in real-time (e.g., dysregulated patient incidents).
+ As a member of the Pediatric Behavioral Health & Wellness Outpatient Services Leadership Team participates in planning & program development and develops written policies and procedures.
+ Responsible for staff recruitment in collaboration with the other Clinical Coordinators and the Director/Chief.
+ Reviews resumes in Workday, identifies qualified candidates, conducts interviews, arranges necessary follow-up interviews, contacts references as needed, and obtains required documentation (e.g., Justice Center Forms, LDSS). Collaborates with other Clinical Coordinators and the Director/Chief to decide on final selection. Supports clinicians with the onboarding process.
+ Establishes and regularly maintains cooperative working relationships with school district personnel where school-based satellites are located, as well as with professional and administrative staff of the Medical Center and University.
+ Responsible for assisting in resolving patient/family concerns that cannot be managed by the assigned clinician, including concerns from the Office of Patient and Family Relations.
+ Conducts Incident Reporting Reviews (CIRR) for assigned site/program.
+ Reviews incidents submitted in RL Solutions to decide if the standard of care has been met and to determine if there is room for improvement.
+ Also, completes Program Level Reviews (PLR) for incidents assigned by the Quality Assurance Team, as well as Special Investigations for cases from other ambulatory services.
+ Serves as a member of Incident Review Committee (IRC). Provides feedback to clinicians, supervisors, and service director/chief.
Other duties as assigned.
**MINIMUM EDUCATION & EXPERIENCE**
+ Master's Degree from a program in a mental health field that is accredited by the Counsel for Accreditation of Counseling and Related Education Programs (CACREP), the American Art Therapy Association, the Commission on Accreditation of Marriage and Family Therapy Education (COAMFTE), or another acceptable accrediting agency as determined by the NY State Office of Professions to be the substantial equivalent of such a registered or accredited program. Required
+ Experience providing clinical services to children with behavioral health disorders and their families. Required
+ 5 or more years of clinical and/or supervisory experience. Required
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Knowledge, skills and abilities to provide mental health services to children and families. Required
+ Excellent supervision skills. Required
+ Excellent interpersonal, problem-solving, crisis management, and organizational skills. Required
**LICENSES AND CERTIFICATIONS**
+ N.Y.S. or National Credential/Certificate in addiction-related specialty upon hire required
+ NYS Certified Alcohol Substance Abuse Counselor if in an Addiction Psychiatry Program upon hire required
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
Notice: If you are a **Current Employee,** please **log into my URHR** to search for and apply to jobs using the Jobs Hub. Your application, if submitted using this portal, cannot be moved forward.
**Learn. Discover. Heal. Create.**
Located in western New York, Rochester is our namesake and our home. One of the world's leading research universities, Rochester has a long tradition of breaking boundaries-always pushing and questioning, learning and unlearning. We transform ideas into enterprises that create value and make the world ever better.
If you're looking for a career in higher education or health care, the University of Rochester may offer the perfect opportunity for your background and goals.
At the University of Rochester, we are committed to fostering, cultivating, and preserving an inclusive and welcoming culture and are united by a strong commitment to be ever better-Meliora. It is an ideal that informs our shared mission to ensure all members of our community feel safe, respected, included, and valued.
Clinical Coordinator - Psych ACT Team
Clinical research associate job in Rochester, NY
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
2613 W Henrietta Rd, Suite A, Brighton, New York, United States of America, 14623
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
500137 Psychiatry SMH Strong Ties
Work Shift:
UR - Day (United States of America)
Range:
UR URCB 212
Compensation Range:
$65,125.00 - $84,662.00
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
Responsible for the administrative, clinical and professional direction of a clinical program in Is responsible for the administrative, clinical and professional direction of a clinical team in Psychiatry offering Forensic Assertive Community Treatment for a cohort of patients with serious mental illness, often comorbid substance use, and involvement with the legal system, who are not engaging in traditional outpatient clinical care. Oversees all administrative and clinical matters on the ACT Team. Manages services and program development; ensures that applicable regulations are operationalized within the program. Responsible for the ongoing performance improvement initiatives on the team. Represents the program to the community, fostering referrals, and assumes teaching and direct clinical care responsibilities. The team provides most of its interventions in the community, wherever the patient is located and provides 24/7 coverage for acute patient needs. ACT services are provided to patients who cannot engage with traditional mental health clinics; thus, the ACT Team Clinical Coordinator engages with multiple government agencies such as the jail, mental health court, homeless shelter providers, etc. to facilitate meeting regulatory requirements and high-quality clinical care. The Clinical Coordinator oversees the daily clinical operations of the interdisciplinary team including making assignments, triaging cases, and prioritizing staff activities to meet acute patient needs. The Clinical Coordinator strives to maintain regulatory required staffing levels through recruitment, onboarding and retention strategies for this team who interact with the most challenging and vulnerable patient population in Behavioral Health clinical services. The Clinical Coordinator is also an integral member of the ACT team, providing comprehensive integrated mental health and substance abuse treatment to enrolled clients and provides administrative and clinical supervision of an interdisciplinary group of clinical staff including multidisciplinary mental health therapists, CASAC's, Rehabilitation Therapists, Case Managers, and other team members.
RESPONSIBILITIES:
Administrative:
Ensures that the ACT team adheres to all aspects of the OMH regulatory requirements for the ACT team in terms of service delivery, documentation that the team completes OMH reporting in a timely and comprehensive manner (i.e., CAIRS, AOT, etc.), billing and data reporting.
Work with Strong Ties leadership and Dept of Psychiatry Utilization Review team to address documentations concerns in a timely way and problem-solving reduction in risk of noncompliance going forward.
Prepares for and participates in regulatory surveys for ACT with the Strong Ties Leadership team and engages in the development, monitoring and evaluation of Performance Improvement Plans required as part of the survey process.
Approval of purchases for patients directly related to patient care as WRAP funding. Ensure appropriate process for procurement card acquisition, purchases, completion of SOE┐s, reconciliation, and doumentation of WRAP utilized per patient.
Facilitates daily team meetings to assign cases to team members and reviews days┐ work responsibilities
Accepts referrals for ACT and completes necessary collaboration with community providers in the assessment and determination for enrollment in ACT. Works with the team to complete the enrollment process as indicated
Supervisory:
Is responsible for the hiring, onboarding, and supporting new clinicians and ACT team staff.
Provides weekly clinical supervision to all direct care staff on the team per OMH guidelines.
Works with Strong Ties leadership and HRBP regarding any staff disciplinary issues.
Provides feedback to the treatment team regarding patient progress in recovery and facilitates and supervises the placement of patient in other community treatment programs as necessary.
Clinical:
Serves as liaison between the ACT program and other community agencies that provide chemical dependence or MICA treatment programs for ACT clients who choose additional or inpatient chemical dependence treatment services.
Serves as liaison between the ACT program and the courts, probation, and parole.
Transports clients as needed to appointments and assists clients in moving or shopping.
Participates in a client on-call phone rotation with other ACT team members once every 5-8 weeks.
The Team Leader also provides back-up (when not directly on call) to any clinical staff on the team that is on call as needed in the event of patient acuity.
Works with clients individually and in group format to help initiate and maintain recovery from substances of abuse and other addictive behaviors.
Engages clients in both individual and group psychoeducational to minimize the incidence of relapse using recovery-based principles, collaboration and shared decision making.
Provides cognitive behavioral therapy for psychosis including education about stress-vulnerability and symptom management.
Monroe County designee to complete 9.45 Mental Hygiene Transport of patients to psychiatric facilities.
Staff Development:
Subscribes to creating a culturally competent environment by treating patient, families, trainees, and co-workers in a sensitive manner with appropriate attention to cultural differences.
Participates in available cultural competency events and training appropriate to job duties.
Participates in OMH led Quality Improvement initiatives specific to ACT.
QUALIFICATIONS:
Masters prepared clinician of any qualified health professional discipline with NYS Licensure or Certification required.
Five years of related clinical, supervisory, and administrative experience, previous experience working in the mental health field with patient experiencing severe mental illness required.
Or equivalent combination of education and experience required.
Previous supervisory experience required.
Must possess a valid NYS driver┐s license in good standing required.
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
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