Clinical research associate jobs in Rochester, NY - 20 jobs
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Clinical Research Associate
Clinical Coordinator
Clinical Research Specialist
Research Coordinator
Clinical Research Coordinator
Clinical Researcher
Sr Clinical Research Data Specialist
Thus Far of Intensive Review
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 clinicalresearch 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 ClinicalResearch Coordinator Preferred
or CCRP - Certified ClinicalResearch 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.
$24.9-34.9 hourly Auto-Apply 60d+ ago
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Clinical Research Coordinator
Iterative Health
Clinical research associate job in Rochester, NY
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch 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.
ClinicalResearch Coordinator
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites 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.
We are seeking a full-time, experienced ClinicalResearch Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
Schedule all patient research visits and procedures consistent with protocol requirements
Conduct patient visits as outlined within each study protocol
Dispense study medication, collect vital signs and perform ECGs
Perform blood draws, process and ship specimens per study protocol and IATA regulations
Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
Act as point of contact for study participants
Adhere to Research SOPs, Good Clinical Practices, and the study protocols
Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
Ensure all safety data is reviewed by the PI in a timely manner
Maintain inventory of study equipment and supplies onsite at all times
Participate actively in communication of status and results to management
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
Schedule and prepare for monitor visits
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
Minimum 1-2 years of clinicalresearch experience
Strong written and verbal communication skills
Ability to read, interpret, and apply clinic policies and research protocols
Ability to use standard office software
Must be able to lift up to 25 pounds
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.
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.
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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 ClinicalResearch Professional by the Association of ClinicalResearch Professionals (ACRP) within 1 year required or
+ SOCRA - Certification In ClinicalResearch 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.
$60.4k-84.6k yearly 45d ago
Clinical Risk Coordinator, prov.
Monroe County, Ny 3.6
Clinical research associate job in Rochester, NY
This is a professional position at Monroe Community Hospital responsible for identifying, reviewing, and investigating potential violations of facility policy and procedure as well as State and Federal regulations, with focus on patient safety and prevention of resident abuse, neglect, and mistreatment. The employee reports directly to, and works under the general supervision of a Quality Assurance Manager or other higher-level staff member. Does related work as required.
Minimum Qualifications
Graduation from high school or possession of an equivalency diploma, plus EITHER:
(A) Graduation with a Bachelor's degree, plus two (2) years paid full‑time or its part‑time equivalent experience in a health or health related field, six (6) months of which must have involved risk management or quality activities; OR,
(B) Graduation with an Associate's degree, plus four (4) years paid full‑time or its part‑time equivalent experience in a health or health related field, six (6) months of which must have involved risk management or quality activities; OR,
(C) An equivalent combination of education and experience as defined by the limits of (A) and (B) above.
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$49k-67k yearly est. 38d ago
ASSISTANT MAAT CLINICAL COORDINATOR
Anthony L. Jordan Health Corporation 3.7
Clinical research associate job in Rochester, NY
Job DescriptionDescription:
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)
$52k-71k yearly est. 26d ago
Admitting Clinical Coordinator
Highland Hospital 4.0
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.
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
$77.2k-93.6k yearly 60d+ ago
Clinical Coordinator - Imaging Sciences
Northeast College of Health Sciences 4.3
Clinical research associate job in Seneca Falls, NY
TITLE: Clinical Coordinator - Radiologic Technology
DEPARTMENT: Imaging Sciences
DIVISION: Academic Affairs
STATUS: Exempt
Note: As a member of our exempt work force there could be occasions when a commitment beyond the normal workweek may be required.
___________________________________________________________________________
Salary: $73,000 to $75,000 annually
BENEFITS:
• Medical Dental Vision Health Savings Account Flexible Spending Account
• College Paid Life, AD&D, LTD insurance Generous PTO 12 Paid Holidays
• TIAA Retirement with 8% college contribution after one year of employment
• Free EAP Counseling Services Free Chiropractic Care
Northeast College of Health Sciences is committed to creating a culture of diversity, equity, inclusion, and belonging with our college campus community. In support of our institutional values, we acknowledge each person's unique experience, perspective, and ability as contributions that both enrich our community and enhance the professions and people we serve. As such, the College is dedicated to providing equitable opportunities to all future and current employees, including those belonging to groups that have been historically underrepresented in higher education.
General Description
The Imaging Sciences Clinical Coordinator is primarily responsible for correlating and coordinating clinical education with didactic education and evaluating its effectiveness within the Radiologic Technology program. The position is a full-time administrative appointment requiring a minimum of 35 hours per week.
Organizational Relationships
Reports to the Director of Imaging Sciences.
Collaborates with faculty, staff, and students within the imaging sciences program.
Serves as the college's clinical site liaison, collaborating with the Clinical Preceptor(s) and Clinical Staff.
Specific Duties and Responsibilities
Participate in didactic and/or clinical instruction. Serve as the course lead for all clinical education courses within Imaging Sciences.
Support the Program Director to assure effective program operations, including but not limited to development, implementation, and evaluation of the programs.
Participate in the accreditation and assessment processes.
Maintain current knowledge of the professional disciplines and educational methodologies through continuing professional development.
Maintain current knowledge of program policies, procedures, and student progress; promote and enforce program and college policies and procedures.
Ensure that the Clinical Preceptors are knowledgeable of the programs mission and goals.
Ensure that the Clinical Preceptors understand the clinical objectives, the clinical evaluation system, and how to evaluate students' clinical competence.
Manage and provide leadership to Clinical Preceptors that provide students with clinical instruction and supervision.
Educate Clinical Preceptors on the assessment process.
Maintain and update program clinical policies and procedures and promote Clinical Preceptors enforcing the policies and procedures.
Educate and ensure Clinical Staff understand the clinical competency system.
Train Clinical Staff that are providing student supervision.
Ensure Clinical Staff are provided resources to evaluate students' clinical competence.
Regularly communicate with Clinical Staff to support the educational process. Routinely perform site visits and hosts annual program meetings.
Ensure Clinical Staff are knowledgeable of program policies, procedures, and student progress.
Provide oversight of all Imaging Sciences clinical educational experiences per course syllabi and course requirements, including but not limited to scheduling rotations, credentialing/health clearance, student assessment, remediations as needed, student expectation and learning progress communications, student advising, course evaluation, and submission of course grade.
Participate in department, division, college, and professional meetings/committees.
Other duties as assigned.
Methods of Accountability
Verbal and written communications with Program Director, faculty, staff, students, and clinical sites.
Compliance with college and clinical sites policies/requirements.
Maintain active involvement with professional, national, and state organizations important to clinical and educational responsibilities.
Annual performance evaluations by the Program Director.
Mental and Physical Requirements
Effective and professional verbal and written communication skills.
Professional demeanor.
Effective critical thinking, problem solving and decision-making skills.
Basic proficiency in PC use and Microsoft Office programs (Word, Excel, PowerPoint, and Outlook) and willingness to learn/use additional software platforms used for student education.
Proficient in imaging sciences equipment used in program.
Manage stressful situations in a fast-paced, multi-task work environment.
Perform all services expected of a licensed Radiologic Technologist and exhibit responsible clinical judgement.
Occasional travel may be required.
Education, Training and Experience
Bachelor's degree required.
Proficient in curriculum development, supervision, instruction, evaluation, and academic advising.
At least two years of clinical experience in imaging sciences.
At least one year experience teaching in a JRCERT accredited discipline.
Holds current American Registry of Radiologic Technologists (ARRT) certification and registration, or its equivalent (an unrestricted license for the state in which the program is located) in radiography.
Appropriate professional licensure to practice in New York State.
Current CPR/FA.
NOTE: Due to the driving/ travel requirements, this position is subject to the College's Motor Vehicle Use Policy and the employee will be required to sign a release for a Motor Vehicle Report upon hire. This release will remain in effect through the duration of employment unless revoked in writing. Motor Vehicle Report checks are conducted annually by the College.
If you are interested in applying for this position; please submit a cover letter of interest, resume and contact information for three professional references to: the Office of Human Resources, 2360 State Route 89, Seneca Falls, NY 13148, or e-mail your response to: ***********************************
* Employment is subject to the favorable result of a background investigation and where applicable, confirmation of appropriate degrees and credentialing.
Northeast College of Health Sciences is an Equal Opportunity employer and does not discriminate against students or employees on the basis of age, race, color, creed, gender, sexual orientation, or handicapping conditions (or any other protected status) in its educational programs, financial aid, activities, admissions and employment practices.
$73k-75k yearly Auto-Apply 30d ago
Human Subject Research Coordinator I
Thus Far of Intensive Review
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.
$21.4-29.9 hourly Auto-Apply 55d ago
Sr Clinical Research Data Specialist
University of Rochester 4.1
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):**
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 clinicalresearch 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 ClinicalResearch Coordinator Preferred
+ or CCRP - Certified ClinicalResearch 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.
$24.9-34.9 hourly 60d+ ago
Admitting Clinical Coordinator
Highland Hospital 4.0
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.
$77.2k-93.6k yearly 60d+ ago
Assistant Maat Clinical Coordinator
Anthony L. Jordan Health Corporation 3.7
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
$21-21.4 hourly 60d+ ago
FT Clinical Coordinator-Imaging Sciences
Northeast College of Health Sciences 4.3
Clinical research associate job in Seneca Falls, NY
For description, visit PDF: ************ northeastcollege. edu/webdocs/hr/Clinical Coordinator-Imaging Sciences 11_2024.
pdf
$57k-68k yearly est. 2d ago
Clinical Research Data Specialist
University of Rochester 4.1
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):**
255 Crittenden Blvd, Rochester, New York, United States of America, 14642
**Opening:**
Worker Subtype:
Regular
Time Type:
Time as Reported / Per Diem
Scheduled Weekly Hours:
As Scheduled
Department:
600223 SON Staff/Research Programs
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:**
Coordinates analytic activities associated with secondary use of large-scale electronic health record data within the Truveta platform for projects examining contraceptive exposure and GLP-1 medication patterns. Assumes responsibility for structured data science workflows, timelines, and documentation requirements. Conducts data extraction, transformation, and analysis tasks that support reproducible research. Maintains data quality processes that support project aims and ensures analytic tasks align with regulatory requirements for use of de-identified patient data.
**ESSENTIAL FUNCTIONS**
Primary Data Management and Extraction in Truveta
+ Executes data extraction workflows within the Truveta environment that support investigation of contraceptive use patterns and GLP-1 medication exposure.
+ Conducts code-based queries, phenotype identification, cohort development, and variable construction.
+ Maintains documentation of analytic decisions and dataset versions to ensure reproducibility.
+ Communicates data anomalies or platform-level issues to the research team.
Data Cleaning, Wrangling, and Quality Control
+ Constructs analytic datasets through iterative cleaning, deduplication, missingness assessment, outlier handling, and normalization of structured clinical concepts.
+ Performs data quality checks and maintains logs that document decisions, discrepancies, and validation steps.
+ Implements processes for ongoing dataset updates in alignment with Truveta refresh cycles.
Statistical and Computational Analysis
+ Conducts statistical analysis using Python, including descriptive analysis, regression modeling, longitudinal pattern analysis, and model diagnostics.
+ Supports development of analytic pipelines for exposure classification, cohort refinement, and sensitivity analyses.
+ Generates tables, figures, and summaries for internal team review and for publication purposes.
Complies with Responsible Conduct of Research and the Code of Federal Regulations.
+ Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
+ 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.
+ 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
+ Experience with statistical programming (Python), data wrangling, or large-scale EHR datasets preferred
**KNOWLEDGE, SKILLS AND ABILITIES**
+ Understanding of data science workflows within large datasets required
+ Ability to follow structured analytic protocols and maintain data integrity. required
+ Experience with EHR data models, OMOP, coding systems (ICD, SNOMED, RxNorm), or de-identified platforms. preferred
+ Proficiency with Python, SQL, Git/GitHub, and documentation tools. preferred
+ Strong communication and organizational skills and ability to work collaboratively in a remote, fast-paced research environment. required
+ Proficient in MS Office (e.g. Word, Excel, and PowerPoint), REDCap. 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.
$21.4-29.9 hourly 18d ago
Clinical Research Data Specialist
University of Rochester 4.1
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):**
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.
$21.4-29.9 hourly 60d+ ago
Clinical Research Spec II
University of Rochester 4.1
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):**
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 clinicalresearch studies as assigned. Assists in day-to-day operations and the implementation of clinicalresearch 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 clinicalresearch 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.
$24.9-34.9 hourly 60d+ ago
Clinical Research Spec II
University of Rochester 4.1
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):**
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 clinicalresearch studies as assigned. Assists in day-to-day operations and the implementation of clinicalresearch 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 clinicalresearch 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.
$24.9-34.9 hourly 54d ago
Research Coordinator - RN
University of Rochester 4.1
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):**
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 clinicalresearch 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**
ClinicalResearch 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.
**ClinicalResearch 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 clinicalresearch 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 clinicalresearch 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.
$35.4-46 hourly 44d ago
Human Subject Research Coordinator I
University of Rochester 4.1
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):**
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.
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.
$21.4-29.9 hourly 60d+ ago
Human Subject Research Coordinator 1
University of Rochester 4.1
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 clinicalresearch 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 clinicalresearch 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 ClinicalResearch 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.
How much does a clinical research associate earn in Rochester, NY?
The average clinical research associate in Rochester, NY earns between $42,000 and $100,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Rochester, NY