Clinical Research Coordinator - Cancer Institute - Danbury, CT (On-site)
Clinical research coordinator job at Danbury Hospital
At Nuvance Health, we enjoy the benefits of a two-state system as we cultivate an inclusive culture where everyone feels welcomed, respected and supported. Together, we are a team of 15,000+ strong hearts and open minds. If you share our values of connected, personal, agile and imaginative, we invite you to discover what's possible for you and your career.
Danbury Hospital, a 456-bed acute care hospital, has been providing award-winning, personalized patient care to the people of Western Connecticut for 140 years. Our specialty areas of excellence include a Level III NICU, a certified Thrombectomy-Capable Stroke Center, and compassionate psychiatric care, including a partial-hospitalization program.
Our accolades include the following:
* The Leapfrog Group - Grade A for quality and patient safety
* U.S. News & World Report - High performance in heart failure treatment
* Healthgrades - One of America's 50 Best Hospitals
* Surgical Review Corporation (SRC) - Robotic Center of Excellence
* Joint Commission - Gold seal of approval in spine surgery
At Danbury Hospital, we take great pride in our team members and their passion for providing the best care possible-always with heart. For many of our team members, that care extends beyond the walls of our hospital. We volunteer at local non-profits and participate in community initiatives and events. Our dedication to the health and well-being of our entire community makes this a truly special place to work.
*Summary:*
Reports to Director of Clinical Trials or Clinical Research Nurse Lead: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in Oncology therapeutic areas. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations.
*Responsibilities:*
Major Accountabilities:
* Screens patients for study participation e.g. reviews medical record, collaborates with medical & research staff, etc. and procures informed consent.,
* Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Enters data. Resolves all patient queries.
* Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians, Monitors), sponsors, federal regulatory agencies, and other involved parties as required.
* Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
* Maintains current regulatory (GCP, HSR) and study specific required trainings.
* Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
* Educates hospital staff about protocols through in-services, written materials and one-on-one interaction, for each study and each patient, and for general marketing.
* Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
* Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within scope of practice and training, consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.
* Fulfills all compliance responsibilities related to the position.
* Performs other duties as assigned.
*Requirements:*
* Bachelor's Degree, Allied health professional degree, or equivalent experience.
* Minimum of one-two (1-2) years' experience with EDC and CRFs.
* Minimum Knowledge, Skills and Abilities Requirements:Ability to multi-task and work as a team and independently.
* Knowledge of Medical Terminology, good clinical practice, FDA, OHRP, and HIPAA policies.
* Outstanding interpersonal communication skills.
* Strong attention to detail, self-motivation, and good organizational skills.
* Ability to prioritize quickly and follow directions and protocol.
*License, Registration, or Certification Requirements:*
* Basic Life Support (BLS) certified or willing to obtain upon employment. Valid driver's license and reliable transportation. PREFER: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or certified within 2 years. Oncology experience is a plus.
Department: Cancer Research
Exempt: Yes
Salary Range: $27.91 - $51.83 Hourly, commensurate with experience.
With strong hearts and open minds, we're pushing past boundaries and challenging the expected, all in the name of possibility. We are neighbors caring for neighbors, working together as partners in health to improve the lives of the people we serve. If you share our passion for the health of our communities, advance your career with Nuvance Health!
We are an equal opportunity employer
Qualified applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.
We will endeavor to make a reasonable accommodation to the known physical or mental limitations of a qualified applicant with a disability unless the accommodation would impose an undue hardship on the operation or our business. If you believe you require such assistance to complete this form or to participate in an interview, please contact Human Resources at ************ (for reasonable accommodation requests only). Please provide all information requested to ensure that you are considered for current or future opportunities.
Dialysis Clinical Coordinator
Greenville, SC jobs
USRC's greatest strength in being a leader in the dialysis industry is our ability to recognize and celebrate the differences in our diverse workforce. We strongly believe in recruiting top talent and creating a diverse and inclusive work climate and culture at all levels of our organization.
The Clinical Coordinator is responsible for assisting with management and operation of clinic. This position assumes full responsibility for the dialysis clinic in the absence of the Administrator.
Growth:
Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments.
Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels.
Demonstrate effective use of supplies and staff labor hours.
Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing.
Perform duties as assigned to meet the patient care or operational needs of the clinic.
Outcomes:
Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare.
Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals.
Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality.
Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals.
Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management.
Operational Readiness:
Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements.
Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations.
Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys.
May assume Charge Nurse's responsibilities as needed.
May fulfill responsibility of facility Alternate CEO as delegated by Governing Body.
Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held monthly as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated.
Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator.
Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
Oversee the maintenance of equipment and supplies to meet current laws and regulations.
Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures.
Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center.
Partnerships:
Maintain collaborative working relationship with Medical Director and physicians.
Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community.
Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization.
Respond effectively to inquiries or complaints.
Staff Development:
Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations.
Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary.
Assists with recruitment, training, development, and supervision of all personnel.
Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees.
Uphold management goals of corporation by leading staff in team concepts and promoting a team effort.
Effectively communicate expectations; accept accountability and hold others accountable for performance.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements include:
Current RN license in applicable state. License must be maintained as current and in good standing.
12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis.
CPR certification required within 90 days of hire.
Confirmation of ability to distinguish all primary colors.
Demonstrated ability to function in a leadership position and to perform in new and emergent situations with sound judgment.
Demonstrated working knowledge of the English language and ability to communicate verbally and in writing.
Must have basic computer skills, including Microsoft Office (Word, Excel, Outlook); proficiency in all USRC clinical applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits: * Medical / Pharmacy * Dental * Vision * Voluntary benefits * 401k with employer match * Virtual Care * Life Insurance * Voluntary Benefits * PTO All Part Time employees are eligible for the following benefits: * 401k with employer match * PTO
Clinic Coordinator - (Mon-Fri 11:30am-8pm)
Belmont, NY jobs
Clinic Coordinator
Location:450 Brookline Ave, Boston, MA 02215 Category:Administration Support/Customer Service Employment Type:full time
Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer.
Responsibilities:
Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process.
Manage complex scheduling to meet patient needs.
Act as a liaison for patients, families and providers.
Respond to emergent and compliance matters with creative problem solving and critical thinking.
Qualifications
Bachelor's degree preferred.
0 - 1 year experience in a customer service setting.
Proficiency in technology and complex computer systems required.
Ability to work in a fast paced and complex clinical environment.
Professional Growth:
The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry.
Well-Being and Benefits
Health, Dental and Vision Insurance
Time Off
Family & Child Care Benefits and Resources
Retirement Programs
Life Insurance
Short Term Disability
Health Savings Account
Flexible Spending Account
Transportation
LGBTQ+
Our Benefits Partners Include:
Harvard Pilgram Health Care
Delta Dental
Eye Med
Fidelity Investments
Sentinel Benefits Group
Prudential
Voya Financial
TIAA
Care.com
Edukate
Headspace
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Join Our Talent Network
Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.
Dialysis Clinical Coordinator
Greenville, SC jobs
USRC's greatest strength in being a leader in the dialysis industry is our ability to recognize and celebrate the differences in our diverse workforce. We strongly believe in recruiting top talent and creating a diverse and inclusive work climate and culture at all levels of our organization.
The Clinical Coordinator is responsible for assisting with management and operation of clinic. This position assumes full responsibility for thedialysis clinic in the absence of the Administrator.
Growth:
Assist with clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments.
Assist with planning/coordinating patient scheduling to assure timely acceptance of patients and effective staffing levels.
Demonstrate effective use of supplies and staff labor hours.
Responsible for updating all logs and ensuring that dialysis run sheets and logs are sent to billing.
Perform duties as assigned to meet the patient care or operational needs of the clinic.
Outcomes:
Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare.
Work with Administrator to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician, and other healthcare professionals.
Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality.
Assist with program's target goals for patient outcomes in accordance with quality patient care and Company goals.
Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting as delegated by Administrator or Management.
Operational Readiness:
Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements.
Work with Administrator to assure clinic is in compliance with all applicable federal, state, and local laws and regulations.
Assist Administrator with development, implementation and follow up of Corrective Action Plans required for internal and external surveys.
May assume Charge Nurse's responsibilities as needed.
May fulfill responsibility of facility Alternate CEO as delegated by Governing Body.
Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director and the staff as delegated. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held monthly as delegated. Assure that Quality Assessment & Performance Improvement Program is current at all times as delegated.
Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center if delegated by Administrator.
Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
Oversee the maintenance of equipment and supplies to meet current laws and regulations.
Responds to all emergencies in clinic. Familiar with emergency equipment and all emergency operational procedures.
Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center.
Partnerships:
Maintain collaborative working relationship with Medical Director and physicians.
Establish and maintain a positive relationship with all Administrators, area hospitals, agencies, vendors and the community.
Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization.
Respond effectively to inquiries or complaints.
Staff Development:
Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations.
Serves as a resource/subject matter expert for patient needs and concerns, staff education and in-service sessions as necessary.
Assists with recruitment, training, development, and supervision of all personnel.
Assists with maintaining effective personnel management and employee relations, including evaluating the performance of all personnel and counseling employees.
Uphold management goals of corporation by leading staff in team concepts and promoting a team effort.
Effectively communicate expectations; accept accountability and hold others accountable for performance.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements include:
Current RN license in applicable state. License must be maintained as current and in good standing.
12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis.
CPR certification required within 90 days of hire.
Confirmation of ability to distinguish all primary colors.
Demonstrated ability to function in a leadership position and to perform in new and emergent situations with sound judgment.
Demonstrated working knowledge of the English language and ability to communicate verbally and in writing.
Must have basic computer skills, including Microsoft Office (Word, Excel, Outlook); proficiency in all USRC clinical applications required within 90 days of hire.
All Full Time employees are eligible for the following benefits:* Medical / Pharmacy* Dental* Vision* Voluntary benefits* 401k with employer match* Virtual Care* Life Insurance* Voluntary Benefits* PTOAll Part Time employees are eligible for the following benefits:* 401k with employer match* PTO
Clinical Research Associate - NAMSA Future Openings USA
Remote
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
Qualifications & Technical Competencies:
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience.
• Preferred monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyClinical Research Coordinator, Sr - Floater
Remote
The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312).
Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights.
Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI.
Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
Coordinate long-term storage of research records in accordance with contractual requirements.
Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response.
Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports.
Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
Adheres to the USRC Research quality assurance program guidelines.
Travel to Investigator Meetings or similar research related meetings is required.
Travel may be required between dialysis facilities or nephrology practices within the community.
Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Participate in staff meetings as required.
Regular and reliable attendance is required for the job.
Clinical Research Regulatory Coordinator I
Boston, MA jobs
Site: Mass General Brigham Incorporated
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
General Summary/Overview Statement:
The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Principal Duties and Responsibilities:
The following regulatory duties will be performed under general supervision by the Clinical Research Manager:
· Maintain and organize study specific regulatory binders
· Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
· Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
· Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
· Submit Data and Safety Monitoring Reports
· Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
· Collect, complete, and submit essential regulatory documents to various regulatory entities
· Participate in monitoring visits and file all monitoring visit correspondence
· Ensure appropriate documentation of delegation and training for all study staff members
· Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
· Careful attention to detail
· Good organizational skills
· Ability to follow directions
· Good communication skills
· Computer literacy
· Working knowledge of clinical research protocols
Qualifications
Education: Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Licenses and Credentials: n/a
Experience:
Knowledge, Skills and Abilities:
- Careful attention to detail.
- Good organizational skills.
- Ability to follow directions.
- Computer literacy.
- Working knowledge of clinical research protocols.
Additional Job Details (if applicable)
Working Conditions:
· Duties will be performed remotely
Remote Type
Remote
Work Location
101 Merrimac Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplyClinical Research Regulatory Coordinator I
Boston, MA jobs
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
General Summary/Overview Statement:
The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Principal Duties and Responsibilities:
The following regulatory duties will be performed under general supervision by the Clinical Research Manager:
* Maintain and organize study specific regulatory binders
* Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
* Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
* Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
* Submit Data and Safety Monitoring Reports
* Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
* Collect, complete, and submit essential regulatory documents to various regulatory entities
* Participate in monitoring visits and file all monitoring visit correspondence
* Ensure appropriate documentation of delegation and training for all study staff members
* Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
* Careful attention to detail
* Good organizational skills
* Ability to follow directions
* Good communication skills
* Computer literacy
* Working knowledge of clinical research protocols
Qualifications
Education: Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Licenses and Credentials: n/a
Experience:
Knowledge, Skills and Abilities:
* Careful attention to detail.
* Good organizational skills.
* Ability to follow directions.
* Computer literacy.
* Working knowledge of clinical research protocols.
Additional Job Details (if applicable)
Working Conditions:
* Duties will be performed remotely
Remote Type
Remote
Work Location
101 Merrimac Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplyJr. Clinical Trials Data Specialist
Remote
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Responsibilities:
Review patient clinical records and use relevant data to determine clinical trial matches.
Independently manage clinical trial workflows, adapting to changing priorities and business needs to ensure efficiency and consistency.
Work collaboratively with cross-functional teams at Tempus (including scientists, pathologists, and product development) to create customized clinical reports.
Navigate and synthesize information from multiple data sources and systems.
Ensure clinical reports are accurate, clear, and aligned with requirements.
Support ongoing and future projects within the team.
Contribute to a dynamic work environment by maintaining flexibility and responsiveness to shifting workflows.
Other duties as assigned.
Qualifications:
Bachelor's or Master's degree in Genetics, Molecular Genetics, Cancer Biology, or Biological Sciences.
Willingness to work flexible hours and adapt to business needs.
Strong written and verbal communication skills.
Proficient in critical thinking, interpersonal, and problem-solving abilities.
Ability to manage complex tasks efficiently under time constraints.
Highly detail-oriented with a commitment to accuracy and consistency.
Self-motivated and able to thrive independently as well as within a collaborative, high-performing team.
Demonstrated passion for making an impact in a fast-paced, mission-driven environment.
Preferred Qualifications:
Experience reviewing hematology/oncology clinical records.
Experience critically evaluating clinical trials.
Basic knowledge of generative AI.
CHI: $46,000-$50,000
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Auto-ApplyClinical Research Coordinator I
Remote
This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour.
St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture.
What We Offer:
Competitive Salary
Comprehensive benefits including Medical, Dental, Vision for you and your immediate family
403b with up to 6% match on Retirement Contributions
Generous Earned Time Off
Growth Opportunities within Healthcare
ST. CHARLES HEALTH SYSTEM
JOB DESCRIPTION
TITLE: Clinical Research Coordinator I
REPORTS TO POSITION: Research Manager
DEPARTMENT: Research
DATE LAST REVIEWED: November 15, 2024
OUR VISION: Creating America's healthiest community, together
OUR MISSION: In the spirit of love and compassion, better health, better care, better value
OUR VALUES: Accountability, Caring and Teamwork
DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care.
POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator.
This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers.
ESSENTIAL FUNCTIONS AND DUTIES:
Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility.
Obtains informed consent according to GCP and ICH guidelines.
Performs study procedures and assessments following protocol specific guidelines.
Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines.
Adheres to St. Charles Health System's compliance plan.
Attends IRB meetings as requested by the IRB.
Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda.
Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level
Prepares for and participates in required sponsor and regulatory audits.
Attend Investigator meetings as required to assure seamless study start-up.
Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects.
Educates patients regarding protocol diagnostic tests and assists with appointments.
Process tissue/blood specimens and prepare it for shipment.
Manages treatment and follow-up schedules to assure protocol compliance.
Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence.
Track study drug usage per protocol and oversee study drug supply.
Maintains subject research records including long-term follow up and reporting.
Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position.
Keeps current with new developments in research methodologies.
Participates in quality assurance program for St. Charles Health System and affiliated research partners.
Supports the vision, mission and values of the organization in all respects.
Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change.
Provides and maintains a safe environment for caregivers, patients and guests.
Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings.
Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate
May perform additional duties of similar complexity within the organization, as required or assigned.
EDUCATION:
Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties.
Preferred: Bachelor of Science degree in related field.
LICENSURE/CERTIFICATION/REGISTRATION
Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification.
Preferred: N/A
EXPERIENCE:
Required: None Required.
Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge.
ADDITIONAL POSITION INFORMATION: N/A
Schedule Weekly Hours:
40
Caregiver Type:
Regular
Shift:
First Shift (United States of America)
Is Exempt Position?
No
Job Family:
COORDINATOR CLERICAL
Scheduled Days of the Week:
Monday-Friday
Shift Start & End Time:
Variable
Auto-ApplyRegistered Nurse / Clinical Research Coordinator
Lake Success, NY jobs
Job Description
The START Center for Cancer Research (“START”) is the world's largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START's mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population - leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many - by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most.
START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda - the most effective cancer drug in medical history.
We are hiring a Clinical Research Coordinator, RN, for our START New York - Long Island location. The Clinical Research Coordinator, RN supports early phase oncology trials under senior research staff guidance. This role ensures accurate, timely research conduct, adhering to protocols, regulatory standards, and patient safety. Responsibilities include direct patient interaction, data collection, maintaining Good Clinical Practice (GCP), overseeing multiple protocols, and coordinating patient participation. The CRC, RN implements and completes protocol requirements, ensuring accurate, up-to-date information is provided to the team.
Address: 450 Lakeville Road, Lake Success, NY 11042
Schedule: Monday through Friday, 8:00am - 5:00pm
This role offers a competitive hourly rate of $60-$75, based on experience and qualifications, along with an annual bonus opportunity of 10%.Essential Responsibilities:
Communicate regularly with Study Sponsors, CROs, and staff regarding protocol status, questions, and concerns.
Monitor day-to-day study conduct to ensure protocol, SOP, and Good Clinical Practice compliance.
Review and create trial forms to ensure protocol compliance.
Maintain organized study files with standardized labeling and filing procedures.
Implement protocols and amendments, training staff on patient treatment and management.
Assist with patient screening, eligibility determination, and informed consent process.
Manage source documents, address protocol deviations, assist with case report forms, and submit Serious Adverse Event reports.
Education & Experience:
Associate's degree in Nursing and RN license in state of Michigan.
2 years of clinical research experience, with a basic understanding of oncology Phase 1 trials.
Strong attention to detail, accuracy in data collection, and ability to meet deadlines.
Excellent organizational, time-management, and communication skills.
Proficient in Microsoft Office Suite, clinical trial management software, and knowledge of GCP and regulatory requirements.
Preferred Education and Experience:
Bachelor's degree in Nursing.
Experience working in an oncology setting.
More about The START Center for Cancer Research
Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including 43 therapies that were approved by the FDA. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.
Ready to be part of a team changing the future of cancer treatment?
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Research Coordinator
New York, NY jobs
How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success.
If this describes you then let's talk!
HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.
Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.
Emp Status
Regular Full time
Work Shift
Day (United States of America)
Compensation Range
The base pay scale for this position is $56,000.00 - $85,250.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.
What you will be doing
Responsibilities include, but are not limited to:
* Contribute to the submission and management (e.g., amendments and continuing reviews) of IRB protocols.
* Integrate study protocol requirements, working with Dr. Otero and different study members or study PIs to coordinate clinical research administration, legal, finance, compliance, and laboratory efforts.
* Contribute to and manage regulatory and patient-facing aspects of clinical studies, including patient screening, enrollment and consent, biospecimen retrieval and transport, and clinical data management.
* Oversee, conduct and manage the informed consent process.
* Coordinate patient research visits, including follow up visits, ensuring adherence to study protocols.
* Ensure compliance with all regulatory requirements, including but not only maintenance of regulatory binders for studies directly led by Dr. Otero and the RC.
* Collect and manage clinical data, ensuring compliance with regulatory aspects and patient privacy.
* Securely access and use EMR systems (e.g., EPIC) and databases (e.g., REDCap).
* Provide training, oversight and consultation to study team members on all study aspects, coordinating with Dr. Otero and specific study PIs (as needed) for IRB submission, patient screening and consent, maintenance of regulatory binders, and biospecimen handling and transportation.
* Conduct literature searches and perform data analyses, in collaboration with the study team and the Department of Biostatistics and Bioinformatics.
* Carry out clerical and technical tasks, including maintaining secure databases.
* Liaise with investigators and Hospital staff, including phone calls, email communications, or videoconferencing.
* Take an active role in data interpretation, generation of reports, presentations, and manuscripts
* Participate in laboratory and departmental meetings
Minimum job requirements:
* Bachelor's degree in life sciences or equivalent.
* Experience with clinical research.
* Technical proficiency and ability to work both independently and as part of a team.
* Ability to learn new tasks following detailed protocols and instructions.
* Excellent time management and organizational skills.
* Proficient use of computers and software.
* Experience managing confidential information.
* Preferred commitment, 2+ years.
Non-Discrimination Policy
Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
Auto-ApplyResearch Coordinator
New York, NY jobs
How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success.
If this describes you then let's talk!
HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.
Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.
Emp Status
Regular Full time
Work Shift
Day (United States of America)
Compensation Range
The base pay scale for this position is $54,000.00 - $82,125.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.
What you will be doing
Reports to: Director of Clinical Research for the Complex Joint Reconstruction Center
The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
SUMMARY:
This individual will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all aspects of research management and quality assurance of data for the projects that will come out of The Complex Joint Reconstruction Center. The candidate will play an integral role in day-to-day research activities and patient coordination ensuring efficient operations.
RESPONSIBILITIES:
Research/Registry:
Coordinates the synchronization of research activities within CJRC under the direction of the Director of Clinical Research and serves as a liaison between the clinicians, research staff, and other research assistants.
Provide overall administrative support for registry/clinical research activities. Provides timely reports to Director, Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
Contributes to all aspects of CJRC research:
* Protocol development
* Recruitment process (conducts informed consent process)
* The development and build of Clinical Research Forms and standard operating procedures as needed by study protocol
* Assures that research is done in an accurate and efficient manner.
Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate.
Handles I.T. communications (requests) and generates reports from the registry as needed.
Facilitates completion of all internal documentation needed for research (IRB applications, conflict of interest forms, data collection forms, etc.)
Assists in data collection for registry/research-specific studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol.
Assists in patient care coordination by assuring patients complete CJRC forms and patient reported outcomes prior to office visits
Responsibilities associated with specific studies include but are not limited to; creation and update of enrollment/screening logs, drug tracking and dispensing, patient contact, administrative support (meetings/minutes/data entry), communication with multidisciplinary study staff, and support for Research Assistants (level 1)
Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
MINIMUM JOB REQUIREMENTS:
Education/Training: Bachelor's degree required, Masters preferred
Experience: 2+ years of experience in clinical research required
Prior Epic experience
Knowledge of Good Clinical Practice and Good Technology Practice
Proficient use of computers and software
Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.
EDUCATION REQUIRED
Bachelors
EDUCATION PREFERRED
CERTIFICATIONS/LICENSURE REQUIRED
CERTIFICATIONS/LICENSURE PREFERRED
SKILLS REQUIRED
SKILLS PREFERRED
Knowledge of Orthopedic and/or Rheumatologic terminology is a plus.
Non-Discrimination Policy
Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
Auto-ApplyClinical Research Coordinator
Amherst, NY jobs
Dent Neurologic Institute is committed to excellence in all we do. Our culture is built on 4 key pillars: respect, quality, productivity, and wellbeing. By remaining dedicated to these values and the overall overall mission, we are dedicated to making a difference for both patients and colleagues. When you join the Dent team, you can take advantage of a variety of benefits:
Work-Life Balance with Set Scheduling (no overnight shifts)
Free Onsite Parking at All Locations
Medical, Dental & Vision Plans
Life Insurance
401(k) Retirement Plan
Critical Illness, Accident, & Legal Plans
Wellness Program
Learning & Development Opportunities
Paid Time Off
Paid Holidays
Schedule: Monday - Friday , 8 hours per day, between 8:00am - 5:00pm
Location: Amherst, NY
Responsibilities include planning, organizing and implementing human subject research for the Dent Neurosciences Research Center according to the procedures set forth in research protocols. The Dent Neuroscience Research Center (DNRC) is a not-for-profit affiliate of DENT dedicated to outcomes research and education supported by foundations, industry and personal contributions. The DNRC is focused on developing comprehensive, clinically relevant, and cost-effective solutions to complex neurological problems faced in our community.
Building awareness, fostering relationships, providing support and continuous education are at the forefront of the DENT philosophy. From providing our patients with the most up-to-date diagnostic and treatment options for assisting each in the best care and coping opportunities, we aim to fulfill the needs of the whole patient. Through foundation support and exceptional faculty leadership, DNRC is able to build upon the philosophy by providing advancement, support, and education to our providers and partners.
Qualifications / Required:
Bachelor's degree or equivalent training preferred
Prior clinical research experience preferred but not required
All personnel drawing blood must be credentialed by Dent phlebotomy protocol; CPR certification preferred.
All personal handling/packaging/shipping hazardous good must become IATA certified
All Personal must receive CITI training, GCP training, NIH training
Strong interpersonal and communication skills
Excellent organizational skills
Problem-solving skills
Computer skills
Ability to manage multiple projects at different stages
Laboratory skills particularly pipetting
High level of communication of interaction with others is required via direct verbal and telephone dialog and in written form; nature of interactions is to give or receive information and knowledge, and to instruct.
Working Conditions:
Moderate physical activity required at times which may include occasional movement of study supplies or equipment.
Also involves driving from office to office depending on study.
Position involves periodic travel throughout the US for investigator meetings and conferences
Compensation:
Most candidates will start within the first quartile of the pay range
Rates are commensurate with experience or certification
EEO Statement : DENT Neurologic Institute is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
Auto-ApplyClinical Research Coordinator
Buffalo, NY jobs
Job DescriptionDent Neurologic Institute is committed to excellence in all we do. Our culture is built on 4 key pillars: respect, quality, productivity, and wellbeing. By remaining dedicated to these values and the overall overall mission, we are dedicated to making a difference for both patients and colleagues. When you join the Dent team, you can take advantage of a variety of benefits:
Work-Life Balance with Set Scheduling (no overnight shifts)
Free Onsite Parking at All Locations
Medical, Dental & Vision Plans
Life Insurance
401(k) Retirement Plan
Critical Illness, Accident, & Legal Plans
Wellness Program
Learning & Development Opportunities
Paid Time Off
Paid Holidays
Schedule: Monday - Friday , 8 hours per day, between 8:00am - 5:00pm
Location: Amherst, NY
Responsibilities include planning, organizing and implementing human subject research for the Dent Neurosciences Research Center according to the procedures set forth in research protocols. The Dent Neuroscience Research Center (DNRC) is a not-for-profit affiliate of DENT dedicated to outcomes research and education supported by foundations, industry and personal contributions. The DNRC is focused on developing comprehensive, clinically relevant, and cost-effective solutions to complex neurological problems faced in our community.
Building awareness, fostering relationships, providing support and continuous education are at the forefront of the DENT philosophy. From providing our patients with the most up-to-date diagnostic and treatment options for assisting each in the best care and coping opportunities, we aim to fulfill the needs of the whole patient. Through foundation support and exceptional faculty leadership, DNRC is able to build upon the philosophy by providing advancement, support, and education to our providers and partners.
Qualifications / Required:
Bachelor's degree or equivalent training preferred
Prior clinical research experience preferred but not required
All personnel drawing blood must be credentialed by Dent phlebotomy protocol; CPR certification preferred.
All personal handling/packaging/shipping hazardous good must become IATA certified
All Personal must receive CITI training, GCP training, NIH training
Strong interpersonal and communication skills
Excellent organizational skills
Problem-solving skills
Computer skills
Ability to manage multiple projects at different stages
Laboratory skills particularly pipetting
High level of communication of interaction with others is required via direct verbal and telephone dialog and in written form; nature of interactions is to give or receive information and knowledge, and to instruct.
Working Conditions:
Moderate physical activity required at times which may include occasional movement of study supplies or equipment.
Also involves driving from office to office depending on study.
Position involves periodic travel throughout the US for investigator meetings and conferences
Compensation:
Most candidates will start within the first quartile of the pay range
Rates are commensurate with experience or certification
EEO Statement
:
DENT Neurologic Institute is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
Monday - Friday, 8 hours per day, between 8:00 am - 5:00 pm
40 hours/week
Clinical Research Coordinator
Charleston, SC jobs
Charleston ENT & Allergy has an immediate opening for a Clinical Research Coordinator! This newly created position reports to the Clinical Research Manager and will provide essential administrative and operational support for all aspects of clinical research studies.
For the right candidate, this role will be interesting, challenging, and fun! You'll have a birds-eye view of the clinical research process, and play a vital role keeping studies on track and moving forward.
This role wears many hats-everything from patient recruitment, screening, and follow-up, to monitoring and documenting adverse events, and preparing and shipping specimens to the lab. Above all, you'll be responsible for maintaining study-related logs and reports, entering data into electronic platforms, and ensuring all study-related data and documentation is archived based on appropriate guidelines and policy.
· Qualified candidates will have CMA, RMA, CCMA, or LPN certification.
· High school diploma or equivalent (GED) and minimum 6 months experience in a medical office or scientific lab environment.
· Good Clinical Practice (GCP) certification is a plus.
· Prior experience in clinical research is a plus.
· Phlebotomy experience a plus, plus!
Charleston ENT & Allergy offers competitive pay, including 401(k) profit sharing plan, medical, dental and vision insurance, company-paid basic life and long-term disability insurance as well as supplemental short-term disability and voluntary life policies.
Charleston ENT & Allergy is an Equal Opportunity Employer
Clinical Research Coordinator
Charleston, SC jobs
Job Description
Charleston ENT & Allergy has an immediate opening for a Clinical Research Coordinator! This newly created position reports to the Clinical Research Manager and will provide essential administrative and operational support for all aspects of clinical research studies.
For the right candidate, this role will be interesting, challenging, and fun! You'll have a birds-eye view of the clinical research process, and play a vital role keeping studies on track and moving forward.
This role wears many hats-everything from patient recruitment, screening, and follow-up, to monitoring and documenting adverse events, and preparing and shipping specimens to the lab. Above all, you'll be responsible for maintaining study-related logs and reports, entering data into electronic platforms, and ensuring all study-related data and documentation is archived based on appropriate guidelines and policy.
· Qualified candidates will have CMA, RMA, CCMA, or LPN certification.
· High school diploma or equivalent (GED) and minimum 6 months experience in a medical office or scientific lab environment.
· Good Clinical Practice (GCP) certification is a plus.
· Prior experience in clinical research is a plus.
· Phlebotomy experience a plus, plus!
Charleston ENT & Allergy offers competitive pay, including 401(k) profit sharing plan, medical, dental and vision insurance, company-paid basic life and long-term disability insurance as well as supplemental short-term disability and voluntary life policies.
Charleston ENT & Allergy is an Equal Opportunity Employer
Research Coordinator
Day, NY jobs
How you move is why we're here. Now more than ever.
Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success.
If this describes you then let's talk!
HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.
Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.
Emp Status
Regular Full time
Work Shift
Day (United States of America)
Compensation Range
The base pay scale for this position is $56,000.00 - $85,250.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing
Responsibilities include, but are not limited to:
Contribute to the submission and management (e.g., amendments and continuing reviews) of IRB protocols.
Integrate study protocol requirements, working with Dr. Otero and different study members or study PIs to coordinate clinical research administration, legal, finance, compliance, and laboratory efforts.
Contribute to and manage regulatory and patient-facing aspects of clinical studies, including patient screening, enrollment and consent, biospecimen retrieval and transport, and clinical data management.
Oversee, conduct and manage the informed consent process.
Coordinate patient research visits, including follow up visits, ensuring adherence to study protocols.
Ensure compliance with all regulatory requirements, including but not only maintenance of regulatory binders for studies directly led by Dr. Otero and the RC.
Collect and manage clinical data, ensuring compliance with regulatory aspects and patient privacy.
Securely access and use EMR systems (e.g., EPIC) and databases (e.g., REDCap).
Provide training, oversight and consultation to study team members on all study aspects, coordinating with Dr. Otero and specific study PIs (as needed) for IRB submission, patient screening and consent, maintenance of regulatory binders, and biospecimen handling and transportation.
Conduct literature searches and perform data analyses, in collaboration with the study team and the Department of Biostatistics and Bioinformatics.
Carry out clerical and technical tasks, including maintaining secure databases.
Liaise with investigators and Hospital staff, including phone calls, email communications, or videoconferencing.
Take an active role in data interpretation, generation of reports, presentations, and manuscripts
Participate in laboratory and departmental meetings
Minimum job requirements:
Bachelor's degree in life sciences or equivalent.
Experience with clinical research.
Technical proficiency and ability to work both independently and as part of a team.
Ability to learn new tasks following detailed protocols and instructions.
Excellent time management and organizational skills.
Proficient use of computers and software.
Experience managing confidential information.
Preferred commitment, 2+ years.
Non-Discrimination Policy
Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
Auto-ApplyResearch Coordinator
Day, NY jobs
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HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.
Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise.
Emp Status
Regular Full time
Work Shift
Day (United States of America)
Compensation Range
The base pay scale for this position is $54,000.00 - $82,125.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future.What you will be doing
Reports to: Director of Clinical Research for the Complex Joint Reconstruction Center
The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
SUMMARY:
This individual will be an integral member of the research team in compliance with all regulatory, institutional, and departmental requirements. The candidate will participate in all aspects of research management and quality assurance of data for the projects that will come out of The Complex Joint Reconstruction Center. The candidate will play an integral role in day-to-day research activities and patient coordination ensuring efficient operations.
RESPONSIBILITIES:
Research/Registry:
Coordinates the synchronization of research activities within CJRC under the direction of the Director of Clinical Research and serves as a liaison between the clinicians, research staff, and other research assistants.
Provide overall administrative support for registry/clinical research activities. Provides timely reports to Director, Institutional Review Board, Principal Investigator, National Institutes of Health and/or sponsor for each research project.
Contributes to all aspects of CJRC research:
-Protocol development
-Recruitment process (conducts informed consent process)
-The development and build of Clinical Research Forms and standard operating procedures as needed by study protocol
-Assures that research is done in an accurate and efficient manner.
Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate.
Handles I.T. communications (requests) and generates reports from the registry as needed.
Facilitates completion of all internal documentation needed for research (IRB applications, conflict of interest forms, data collection forms, etc.)
Assists in data collection for registry/research-specific studies including but not limited to the performance of measurements for applicable studies, collection of clinical data from patients directly, and manage the performance of all other duties as put forth in the protocol.
Assists in patient care coordination by assuring patients complete CJRC forms and patient reported outcomes prior to office visits
Responsibilities associated with specific studies include but are not limited to; creation and update of enrollment/screening logs, drug tracking and dispensing, patient contact, administrative support (meetings/minutes/data entry), communication with multidisciplinary study staff, and support for Research Assistants (level 1)
Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of research data management.
MINIMUM JOB REQUIREMENTS:
Education/Training: Bachelor's degree required, Masters preferred
Experience: 2+ years of experience in clinical research required
Prior Epic experience
Knowledge of Good Clinical Practice and Good Technology Practice
Proficient use of computers and software
Knowledge of Orthopaedic and/or Rheumatologic terminology is a plus.
EDUCATION REQUIRED
Bachelors
EDUCATION PREFERRED
CERTIFICATIONS/LICENSURE REQUIRED
CERTIFICATIONS/LICENSURE PREFERRED
SKILLS REQUIRED
SKILLS PREFERRED
Knowledge of Orthopedic and/or Rheumatologic terminology is a plus.
Non-Discrimination Policy
Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.
Auto-ApplyClinical Coordinator Rapid Response
Clinical research coordinator job at Danbury Hospital
at Norwalk Hospital Association
Provides critical care support to the nursing staff in all areas of the hospital to include transport of critically ill patients, member of the code team, rapid response team, and acute stroke team. Educates staff and provides team member development. Reports to Patient Care Director.
Responsibilities:
1. Care Delivery/Therapeutic Interventions Criteria A: Adheres to established Nursing Standards of Practice to include: Assessment, Planning, Implementation and Evaluation. Care Delivery/Therapeutic Interventions Criteria B: Participates in a committee as designated by Patient Care Director. Care Delivery/Therapeutic Interventions Criteria C: Administers medication/IV solution according to Norwalk Hospital policy/procedure and consults appropriate resources for information as needed. Care Delivery/Therapeutic Interventions Criteria D: Develop, plan, initiate and evaluate patient care interventions within the scope of practice for the unit and the organization.
2. - Crisis Management Criteria A: Responds to cardiac arrest/trauma alerts/stroke alerts/rapid response team in a timely manner and is supportive of team efforts. - Crisis Management Criteria B: Specific duties may include providing nursing care of the patient from resuscitation through inpatient admission. Assists the staff nurse with the patient that has a change in status warranting immediate intervention and potential transfer to critical care areas, as a member of the rapid response team. - Crisis Management Criteria C: Transports critically ill patients to procedures and tests as requested. - Crisis Management Criteria D: Direct staff member and independently assign responsibilities as needed during an emergent situation.
3. Clinical Resource / Support Criteria A: Is a resource and supports staff with clinical problems that may arise and assures standards and protocols are followed. Clinical Resource / Support Criteria B: Facilitates interdisciplinary patient care to provide quality outcomes. Clinical Resource / Support Criteria C: Responds to the needs of the unit in a timely manner.
4. Professional & Personal Responsibilities Criteria A: Pursues professional education to meet the needs of current position and professional goals. Professional & Personal Responsibilities Criteria B: Participates in Nursing/Hospital committees. Professional & Personal Responsibilities Criteria C: Participates in professional organizations, maintains and updates educational records and attends annual required reviews. Professional & Personal Responsibilities Criteria D: Hold self and others accountable for actions and outcomes.
5. Coordination / Consultation Criteria A: Maintains contact with the clinical nurse manager throughout the shift. Coordination / Consultation Criteria B: Shares expertise with nursing / hospital personnel as requested. Coordination / Consultation Criteria C: Serves as a resource and support person to nursing / hospital staff. patients and their families. Coordination / Consultation Criteria D: When involved in a clinical situation that requires decision making and prioritization of needs, independently and appropriately directs other staff members in care of the patient to meet the needs of the patient and the clinical area.
6. - Team Building / Staff Development Criteria A: Participates in the development of team members during clinical calls and consistently teaches staff members during the event , by among other means during their work. - Team Building / Staff Development Criteria B: Coordinates and facilitates interdisciplinary patient care to provide quality outcomes. - Team Building / Staff Development Criteria C: Observes and identifies staff learning need / competencies and provides an environment for learning. Educates staff utilizing various modes of teaching consistent with adult learning. - Team Building / Staff Development Criteria D: Facilitates critical thinking of staff members in caring for patients. Identifies opportunities for teaching and encourages staff to include all pertinent information related to patient care when decisions are made.
7. Human Resources Management Criteria A: Assists with staff development. Human Resources Management Criteria B: Promotes continuing education by encouraging staff to participate in educational offerings within or outside the institution. Human Resources Management Criteria C: Participates in the interviewing process for new staff and makes recommendation for hiring. Assists with completion of unit based competencies in collaboration with the manager and educator. Human Resources Management Criteria D: Provides staff development concerning diagnostic studies, disease entities, policy or procedural changes and other areas leading to an enhancement of knowledge or skills.
8. Leadership Criteria A: Serves as a change agent assisting others in understanding the importance, necessity, impact and process of change. Leadership Criteria B: Demonstrates the value of life long learning through one's own example. Leadership Criteria C: Is a positive example and promotes a positive and creative work environment. Promotes positive working relationships between units.
9. Performs other duties as assigned.
10. Fulfills all compliance responsibilities related to the position.
Education: BACHELOR'S LVL DGRE
Other Information:
Bachelor's Level Degree or within two years
Required: RN License in Connecticut.
Minimum of 2 years' experience in a critical care setting.
Minimum Experience: three years
ACLS certification, BLS (HCP) certification, NIHSS certification, IV certified, CPI certification, and PALS certification within 1 year, TNCC within 1 year.
Prefer: Desired: CCRN Certified to conscious sedation standards and SCRN certified
Working Conditions:
Manual: significant manual skills/motor coord & finger dexterity
Occupational: Significant occupational risk
Physical Effort: Very Heavy effort. May exert up to 50 lbs. force
Physical Environment: Some exposure to dirt, odors, noise, human waste, etc.
Credentials:ACLS,BLS,IV,RN,NIHSS,CPI
Company: Norwalk Hospital Association
Org Unit: 380
Department: Nursing Rapid Response Team
Exempt: Yes
Salary Range: $45.29 - $64.70 Hourly
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