Research Nurse jobs at Hackensack Meridian Health - 74 jobs
Clinical Research Coordinator
Hackensack Meridian Health 4.5
Research nurse job at Hackensack Meridian Health
Our team members are the heart of what makes us better. At **Hackensack Meridian** **_Health_** we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The **Clinical Research Coordinator** is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.
**Education, Knowledge, Skills and Abilities Required** :
+ BA/BS diploma/degree in science or healthcare field.
+ Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
+ Strong attention to detail and customer service focus.
+ Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
+ Excellent organizational, presentation, documentation and interpersonal skills.
+ Excellent written and verbal communication skills.
+ Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
**Education, Knowledge, Skills and Abilities Preferred** :
+ Education on human subject research and GCP.
**Licenses and Certifications Preferred** :
+ SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
175288
Minimum rate of $82,513.60 Annually
HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:
+ Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
+ Experience: Years of relevant work experience.
+ Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
+ Skills: Demonstrated proficiency in relevant skills and competencies.
+ Geographic Location: Cost of living and market rates for the specific location.
+ Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
+ Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.
Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.
In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
$82.5k yearly 2d ago
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Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Los Angeles, CA jobs
This role offers a **fully remote work arrangement** . Please note that **applicants must be based in California** to be considered for this opportunity
This position is a **post-award** role, meaning the incumbent will support sponsored research projects **after funding has been awarded** . Responsibilities include financial management and oversight of active grants and contracts, such as monitoring budgets and expenditures, ensuring compliance with sponsor and institutional policies, processing financial transactions, preparing financial reports, and partnering closely with investigators and research teams to support the ongoing fiscal health of awarded studies. This role does not focus on proposal development or grant submission activities.
The Clinical Research Finance Coordinator III develops highly complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost allocation, negotiates budgets, details budgets, and responsible for monitoring and invoicing. Plans and coordinates strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
**Primary Duties and Responsibilities**
+ Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details.
+ Evaluates highly complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments. Processes Ancillary Agreements with departments providing research services.
+ Determines whether research procedures in the protocol are standard-of-care or a research-related cost in order to correctly classify expenses.
+ Develops highly complex clinical trial budgets sponsored for industry and the National Institutes of Health (NIH), investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects. Reviews and approves internal and/or satellite site budgets.
+ Negotiates trial budgets and payment terms with industry sponsors.
+ Monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and determines the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. Conducts quality review and/or audits of clinical trial budgets. Serves as point of contact for fiscal related questions and engages management as appropriate.
+ Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Works closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
+ Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability, and makes recommendations and/or creates proposals to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
+ Enters financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes study calendars to ensure agreement with Medicare coverage analysis and clinical trials budget.
+ Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval.
+ Reviews protocol amendments for impact to sponsored research budget/contract. Processes budget/contract amendments as applicable.
+ Provides training, education, onboarding and mentors other personnel.
+ Plans and coordinates strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. Identifies quality and performance improvement opportunities and work with management to lead the development of new (or improvement of existing) processes, policies or standard operating procedures. Assists with business software launches, implementation or optimization.
+ May lead or facilitate team meetings.
**Qualifications**
**Requirements:**
+ High School Diploma/GED.
+ 5 years of Experience with billing, accounting, accounting, finance, financial analysis or related field.
+ 2 years of Experience in clinical research.
**Preferred:**
+ Bachelors in Accounting, Finance, or other related degree
**Req ID** : 13660
**Working Title** : Clinical Research Finance Coordinator III - Post Award
**Department** : Cancer - SOCCI Clinical Research
**Business Entity** : Cedars-Sinai Medical Center
**Job Category** : Academic / Research
**Job Specialty** : Contract & Grant Budget/Fund
**Overtime Status** : EXEMPT
**Primary Shift** : Day
**Shift Duration** : 8 hour
**Base Pay** : $41.42 - $70.41
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.
$41.4-70.4 hourly 2d ago
IRB Administrator / TSRI- Human Research Protection Program / Full-time / Days
Childrens Hospital Los Angeles 4.7
Los Angeles, CA jobs
NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children.
The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation.
Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding.
It's Work That Matters.
Overview
This position is 100% remote. CHLA does require a primary residence in CA prior to start date.
Schedule: M-F
Purpose Statement/Position Summary: Under supervision, supports the efficiency of the Human Subjects Protection Program in the areas of protocol reviews, liaison with the Institutional Review Board, and simple to moderately complex correspondence.
Minimum Qualifications/Work Experience: 1+ years IRB experience.
Education/Licensure/Certification: Bachelor's degree in a scientific or business discipline or an equivalent combination of relevant education and work experience.
Pay Scale Information
USD $70,304.00 - USD $104,832.00
CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures.
Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career!
CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932.
At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance.
Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process.
Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA.
TSRI - Human Research Protection Program
$70.3k-104.8k yearly 23d ago
Research Coordinator I
Centerstone 4.2
Fort Myers, FL jobs
Centerstone is among the nation's leading nonprofit behavioral health systems with thousands of employees dedicated to delivering care that changes people's lives. A dynamic, well-established organization, we offer rewarding opportunities to serve all ages in a variety of settings. Come talk to us about joining the Centerstone team!
JOB DESCRIPTION:
SUMMARY OF POSITION
Centerstone's Institute works to support the organization's mission of delivering care that changes people's lives by generating knowledge that transforms behavioral healthcare and translating that knowledge meaningfully into behavioral healthcare practice. Our main goal is closing the research-to-practice gap so our clients can receive excellent behavioral healthcare and achieve their best outcomes. We bring technology, innovation, and multidisciplinary approaches to the forefront in all we do. We aim to set standards for the mental health care field as a whole.
As a Research Associate at Centerstone's Institute, you will provide a wide array of support for evaluation projects, including Data Collection and Data Management, Research/Evaluation Planning, Data Reporting and Dissemination, and other tasks related to program evaluation. You will work closely with the Lead Evaluator and clinical program staff to achieve program goals and objectives and address any barriers to achieving these goals. The ideal candidate will demonstrate effective communication skills, the capacity to work effectively independently, and within a functional team, while managing responsibilities and prioritizing tasks in an environment with overlapping activities and competing priorities.
ESSENTIAL DUTIES & RESPONSIBILITIES
Research/Evaluation Planning and Organizing
Contribute to the planning, implementation, and maintenance of evaluation and research projects
Assist with the recruitment and tracking of evaluation participants
Conduct surveys, interviews and engage in other primary and secondary data collection
Support the evaluation team in the development of surveys, questionnaires, reports and presentations
Data Collection, management, and analysis
Collect and submit all project data as required by funding agencies (e.g., adhere to follow-up data collection schedules, conduct phone calls/text communication, maintain databases, and complete data entry within specific time requirements) as directed by the Lead Evaluator
Assist with coding and organizing data for analysis and interpretation
Use hardware and software for data management, data analysis, document creation, and system maintenance, that may include (but not be limited to) Microsoft Outlook, Excel, PowerPoint, Access, SPSS, REDCap, SPARS, Atlas ti
Data Reporting and Dissemination
Communicate clearly and effectively with staff, supervisors, and others of diverse social, cultural, economic, and educational backgrounds
Maintain accurate records, coordinate multiple tasks, and ensure comprehensive documentation of operations
Assist the Lead Evaluator, evaluation staff, and clinical personnel in the effective dissemination and utilization of evaluation information
Assist with the creation of data visualization graphics and narrative interpretation
When able, attend and present program findings at conferences
Organizational Development
Participate in Program Evaluation Departmental initiatives and meetings, Institute, and Centerstone as a whole, including attendance at Town Halls, Table Topics, Employee Resource Groups, and other developmental or educational activities as directed by the Lead Evaluator or supervisor
KNOWLEDGE, SKILLS & ABILITIES
Ability to effectively work remotely and maintain a professional demeanor
Able to communicate clearly and effectively with staff, supervisors and others.
Possesses organizational skills to maintain records and coordinate other tasks.
Skilled in speaking and writing to persons of various social, cultural, economic and educational backgrounds.
Familiarity with behavioral sciences
Competent in the use of personal computers and software (i.e. Excel, Access, SPSS, Atlas ti). Able to perform basic qualitative and/or quantitative data analysis. Assists in quality improvement activities.
Capacity to work both independently as well as within a team,.
Capacity and interest in learning how to apply social science research methods to the field of evaluation, which aims to improve the performance or efficiency of individuals, groups, programs, policies, government and others, capacity to manage responsibilities and prioritize tasks in an environment with many activities and competing priorities.
QUALIFICATIONS
Education Level
· Bachelor's degree preferred
· Associate's degree OR equivalent combination of four (4) years of post-secondary education, training, and experience in social sciences, mental health, or experience providing customer service or technical support will be accepted in lieu of the Associate's degree.
Years of Experience
Minimum of 1 year of progressive experience in program evaluation or research, and superior performance on an evaluation or research project is preferred.
Certification/Licensure
Possess a valid driver's license, current auto insurance and willing/able to travel locally
PHYSICAL REQUIREMENTS
Standing - 10%
Sitting - 90%
Squatting - Occasional
Kneeling - Occasional
Bending - Occasional
Driving - Occasional
Lifting - Occasional
DISCLAIMER
The duties and responsibilities described in this document are not a comprehensive list and additional tasks may be assigned to the employee from time to time, or the scope of the job may change as necessitated by business demands.
Time Type:
Full time
Pay Range:
$15.00--$21.00
Delivering care that changes people's lives starts with our employees. Below are just some of the great benefits Centerstone employees enjoy:
Medical, dental, and vision health coverage
Flexible Spending and Health Savings Accounts
403b retirement plan with company match
Paid time off and ten paid holidays
AD&D Insurance, Life Insurance, and Long Term Disability (company paid)
Employee Resource Groups
Continuing education opportunities
Employee Assistance Program
Centerstone is an equal opportunity employer. Employment at Centerstone is based solely on a person's merit and qualifications directly related to professional competence. We treat all clients and colleagues with dignity and respect.
At Centerstone, we use our values as a guide for what we do. Respect, Expertise, Integrity and Empowerment are at the heart of every interaction at Centerstone, and particularly rooted in our Culture.
Our approach to culture is to create an environment that encourages, supports and celebrates the voices and experiences of our employees. We are committed to a culture of empowerment, respect, integrity and expertise that powers our innovation and connects us to each other, our clients and the communities we serve.
Centerstone is also committed to a strong culture of quality and safety, celebrating role-models who champion best practices for quality, clinical risk, and patient safety.
$15 hourly Auto-Apply 5d ago
Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
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.
$54.4k-80.1k yearly Auto-Apply 60d ago
Associate Research Coordinator-PRN
Ochsner Health 4.5
New Orleans, LA jobs
**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.**
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job evaluates, initiates, and maintains activities related to the conduct of clinical trials with the assistance and guidance of departmental staff.
Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials.
Organizes and manages all patient care requirements of the company with the direction and approval of other research staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.
**Education**
Required - High school diploma or equivalent.
**Work Experience**
Required - 1 year of relevant research or clinical experience,
OR
Bachelor's degree in life science or related field.
**Certifications**
Required - Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
**Knowledge Skills and Abilities (KSAs)**
+ Knowledge of medical and clinical research terminology and processes.
+ Familiarity with ICH guidelines for ethical conduct of research.
+ Ability to follow the investigational plan in execution of study visits.
+ Strong organizational and time management skills and ability to multi-task and pay close attention to detail.
+ Knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
+ Proficiency in using computers, software, and web-based applications, including working knowledge of Epic.
+ Effective verbal and written communication skills.
+ Organizational and time management skills and ability pay close attention to detail.
+ Ability to travel throughout and between facilities and work a flexible work schedule.
**Job Duties**
+ Assists in recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
+ Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials including informed consent under direction and supervision of more senior research staff.
+ Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
+ Performs clinical laboratory activities as required per protocol.
+ Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
+ Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution.
+ Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
+ Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
+ Performs other related duties as assigned.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards.
This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
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.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Duties performed routinely require exposure to blood, body fluid and tissue.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases.
Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
**_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or_** **_*******************_** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
$36k-50k yearly est. 7d ago
Associate Research Coordinator-PRN
Ochsner Health System 4.5
New Orleans, LA jobs
We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.
At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!
This job evaluates, initiates, and maintains activities related to the conduct of clinical trials with the assistance and guidance of departmental staff. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company with the direction and approval of other research staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.
Education
Required - High school diploma or equivalent.
Work Experience
Required - 1 year of relevant research or clinical experience,
OR
Bachelor's degree in life science or related field.
Certifications
Required - Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
Knowledge Skills and Abilities (KSAs)
Knowledge of medical and clinical research terminology and processes.
Familiarity with ICH guidelines for ethical conduct of research.
Ability to follow the investigational plan in execution of study visits.
Strong organizational and time management skills and ability to multi-task and pay close attention to detail.
Knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
Proficiency in using computers, software, and web-based applications, including working knowledge of Epic.
Effective verbal and written communication skills.
Organizational and time management skills and ability pay close attention to detail.
Ability to travel throughout and between facilities and work a flexible work schedule.
Job Duties
Assists in recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials including informed consent under direction and supervision of more senior research staff.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Performs clinical laboratory activities as required per protocol.
Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution.
Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
Performs other related duties as assigned.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards.
This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Physical and Environmental Demands
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.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Duties performed routinely require exposure to blood, body fluid and tissue.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases.
Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.
Are you ready to make a difference? Apply Today!
Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website.
Please refer to the job description to determine whether the position you are interested in is remote or on-site.
Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.
Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or
*******************
. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
$36k-50k yearly est. Auto-Apply 9d ago
Senior Clinical Research Coordinator - Jefferson Hwy - Full Time
Ochsner Health System 4.5
New Orleans, LA jobs
We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.
At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!
This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Independently organizes and manages all patient care requirements of the company. Serves as an escalation point for junior level departmental staff for problem resolution and support, and coordinates trials that are the most complex and/or the greatest number of trials.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.
Education
Required - High school diploma or equivalent.
Work Experience
Required - 5 years of relevant research experience in a clinical setting,
OR
4 years of relevant research experience in a clinical setting with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.
Certifications
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
Knowledge Skills and Abilities (KSAs)
Knowledge of medical and clinical research terminology and processes.
Expert understanding of ICH guidelines for ethical conduct of research.
Familiarity with and understanding of lean management principles.
Ability to follow and provide critical feedback on the investigational plan.
Ability to develop study related budgets, contracts, and patient consent documents.
Ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activity.
Expertise in using computers and web-based applications including working knowledge of Epic (Super-Users).
Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
Strong interpersonal and leadership skills and ability to coach others, as well as effectively work independently.
Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and develop new techniques.
Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.
Job Duties
Evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings and coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI).
Serves as primary point of contact for patient to report and triage adverse events and serves as a mentor to staff on obtaining informed consent.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment.
Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies.
Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
Provides mentorship, professional development, and support to less senior team members and interns; assesses quality assurance of study visits and data; periodically reviews and provides constructive feedback on standard operating procedures; and coordinates special projects related to workflow optimization.
Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
Performs other related duties as assigned.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards.
This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Physical and Environmental Demands
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.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Duties performed routinely require exposure to blood, body fluid and tissue.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases.
Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.
Are you ready to make a difference? Apply Today!
Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website.
Please refer to the job description to determine whether the position you are interested in is remote or on-site.
Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C.
Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or
*******************
. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
$39k-55k yearly est. Auto-Apply 2d ago
Research Coordinator
Regional Cancer Care Associates 4.2
Sparta, NJ jobs
Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you!
Employment Type: Full Time
Location: Sparta, NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills, experience, and qualifications
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate understanding of the protocol elements and requirements.
Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
Screening, recruit, enroll prospective patients using EMR, EDC, CTMS
Create and maintain enrollment logs for each trial from beginning to end
Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
Enter all the data to EDC, and EMR within 24 hours of data collection.
Communicate and resolve all the data queries within 5-days
Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
Supports internal and external audits
Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
Conduct clinical trial weekly and monthly meetings within the division.
Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
Track and submit clinical trial patient reimbursement.
Other duties as assigned.
Requirements
Minimum Job Qualifications:
Minimum 1 year of experience with oncology interventional clinical trials.
ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience.
High School diploma with four years of oncology clinical trial experience.
Computer literate with good interpersonal, writing, and verbal communication skills.
Previous regulatory affairs experience is a plus.
Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
Prior experience working with centrifuge and handling biofluid specimens is preferred.
Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.)
Large percent of time performing computer based work is required
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 will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Salary Description $27.09 - $36.54
$27.1-36.5 hourly 60d+ ago
Research Coordinator
Regional Cancer Care Associates 4.2
Freehold, NJ jobs
Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you!
Employment Type: Full Time
Location: Freehold, NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills, experience, and qualifications
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate understanding of the protocol elements and requirements.
Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
Screening, recruit, enroll prospective patients using EMR, EDC, CTMS
Create and maintain enrollment logs for each trial from beginning to end
Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
Enter all the data to EDC, and EMR within 24 hours of data collection.
Communicate and resolve all the data queries within 5-days
Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
Supports internal and external audits
Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
Conduct clinical trial weekly and monthly meetings within the division.
Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
Track and submit clinical trial patient reimbursement.
Other duties as assigned.
Requirements
Minimum Job Qualifications:
Minimum 1 year of experience with oncology interventional clinical trials.
ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience.
High School diploma with four years of oncology clinical trial experience.
Computer literate with good interpersonal, writing, and verbal communication skills.
Previous regulatory affairs experience is a plus.
Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
Prior experience working with centrifuge and handling biofluid specimens is preferred.
Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.)
Large percent of time performing computer based work is required
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 will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Salary Description $27.09 - $36.54
$27.1-36.5 hourly 60d+ ago
Research Coordinator
Regional Cancer Care Associates 4.2
Howell, NJ jobs
Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you!
Employment Type: Full Time
Location: Howell, NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills, experience, and qualifications
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate understanding of the protocol elements and requirements.
Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
Screening, recruit, enroll prospective patients using EMR, EDC, CTMS
Create and maintain enrollment logs for each trial from beginning to end
Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
Enter all the data to EDC, and EMR within 24 hours of data collection.
Communicate and resolve all the data queries within 5-days
Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
Supports internal and external audits
Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
Conduct clinical trial weekly and monthly meetings within the division.
Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
Track and submit clinical trial patient reimbursement.
Other duties as assigned.
Requirements
Minimum Job Qualifications:
Minimum 1 year of experience with oncology interventional clinical trials.
ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience.
High School diploma with four years of oncology clinical trial experience.
Computer literate with good interpersonal, writing, and verbal communication skills.
Previous regulatory affairs experience is a plus.
Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
Prior experience working with centrifuge and handling biofluid specimens is preferred.
Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.)
Large percent of time performing computer based work is required
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 will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Salary Description $27.09 - $36.54
$27.1-36.5 hourly 60d+ ago
Clinical Trials Coordinator II
St. Joseph's Healthcare System 4.8
New Jersey jobs
Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality. Navigate patients through clinical trials.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Bachelors degree in Business, public health , or healthcare administration or closely related field, and two to four years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred.
$50k-67k yearly est. Auto-Apply 3d ago
Clinical Trials Coordinator
St. Joseph's Healthcare System 4.8
Paterson, NJ jobs
Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.
$50k-67k yearly est. Auto-Apply 7d ago
Clinical Trials Coordinator
St. Joseph's Healthcare System 4.8
Paterson, NJ jobs
Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.
St. Joseph's Health is recognized for the expertise and compassion of its highly skilled and responsive staff. The combined efforts of the organization's outstanding physicians, superb nurses, and dedicated clinical and professional staff have made us one of the most highly respected healthcare organizations in the state, the largest employer in Passaic County, and one of the nation's "100 Best Places to Work in Health Care".
$50k-67k yearly est. Auto-Apply 60d+ ago
Clinical Trials Coordinator II
St. Joseph's Health 4.8
New Jersey jobs
Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality. Navigate patients through clinical trials.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Bachelors degree in Business, public health , or healthcare administration or closely related field, and two to four years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred.
$47k-64k yearly est. Auto-Apply 3d ago
Clinical Trials Coordinator
St. Joseph's Health 4.8
Paterson, NJ jobs
Under general supervision, coordinates clinical research protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality.t.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinical research or clinical trials coordination program management preferred.
$47k-64k yearly est. Auto-Apply 7d ago
Oncology Research Nurse Nav I PRN
Cooper University Hospital 4.6
Camden, NJ jobs
About Us
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description
Oncology and Research are specialized and require unique skill sets. Realigning our MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston's recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients advanced care. The role of the ResearchNurse Navigator provides advanced clinical management of research protocols.
Research:
1.1 Works with research team to identify clinical trials that would be beneficial to the patient population.
1.2 Works with other nurse navigators to facilitate and assess possible patients for clinical trials, referring possible eligible patients to Research Department. Reviews physician schedules and patient charts to pre-screen inclusion criteria
1.3 Promotes research-based therapies/education to patients.
1.4 Works with clinical research coordinators to develop operational flow plans for each active research protocol
New Patient Support & Education:
2.1 Educates, supports, and assists patients and their families, serving as a link to their doctors and supportive services before, during, and after their participation in a research study. This role is key in the implementation of multidisciplinary care throughout participation in a research protocol.
2.2 Facilitates and implements multidisciplinary cancer care for new research patients within the Cooper Cancer Institute. Functions across all disease sites and, therefore, is a vital resource for information and education related to all cancer research protocols.
2.3 Serves as liaison between new patients, physicians, and diagnostic services in order to expedite the start of participation in a research protocol. Explains role of nurse navigator to patient and family, triages/forwards questions to the appropriate disciplines
2.4 Understands the demands and experiences of cancer, the disease process/treatment and anticipates patient and family needs. Identifies areas in which the patient/family lack knowledge, then provides supportive information/teaching, incorporating the patient's cultural/spiritual beliefs.
2.5 Facilitates patient participation and control in clinical decision-making while providing emotional and informational support to the patient and family.
2.6 Completes all related documentation in a timely manner; provides communication throughout the oncology research team on an on-going basis.
2.7 Utilizes available data bases and other files in a manner that is understandable and accessible to other members of the team.
New Patient Support & Education:
2.1 Educates, supports, and assists patients and their families, serving as a link to their doctors and supportive services before, during, and after their participation in a research study. This role is key in the implementation of multidisciplinary care throughout participation in a research protocol.
2.2 Facilitates and implements multidisciplinary cancer care for new research patients within the Cooper Cancer Institute. Functions across all disease sites and, therefore, is a vital resource for information and education related to all cancer research protocols.
2.3 Serves as liaison between new patients, physicians, and diagnostic services in order to expedite the start of participation in a research protocol. Explains role of nurse navigator to patient and family, triages/forwards questions to the appropriate disciplines
2.4 Understands the demands and experiences of cancer, the disease process/treatment and anticipates patient and family needs. Identifies areas in which the patient/family lack knowledge, then provides supportive information/teaching, incorporating the patient's cultural/spiritual beliefs.
2.5 Facilitates patient participation and control in clinical decision-making while providing emotional and informational support to the patient and family.
2.6 Completes all related documentation in a timely manner; provides communication throughout the oncology research team on an on-going basis.
2.7 Utilizes available data bases and other files in a manner that is understandable and accessible to other members of the team.
Program Development:
3.1 Implements Research Physician outreach by assisting to identify areas of outreach need, overseeing physician outreach plans, and analyzing programmatic patient referrals and growth.
3.2 Works with Events Coordinator and program physicians in the planning and implementation of Research Community Education Programs.
Multidisciplinary Tumor Board :
4.1 Attends and participates in Disease-Specific Tumor Boards.
4.2 Follows up and oversees if research plan agreed upon at tumor board is relayed to patient and necessary action taken. Also relays the agreed upon research follow up plan in writing to the multidisciplinary and clinical research teams.
4.3 Participates in multidisciplinary rounds and conferences. Helps to coordinate and assure all necessary data is available for multidisciplinary cancer team conference.
Education:
5.1 Works with all CCI disciplines to develop, implement, participate and evaluate oncology research programs for patients, healthcare professionals and the community. Acts as liaison with outside research agencies
5.2 Develops educational resources for cancer patients and families interested in clinical research.
5.3 Provides education within the Cooper network and outside the institution as needed.
5.4 Provides educational programs and lectures for oncology fellows, surgical residents, medical students, and nurses.
5.5 Assists with onboarding and training of new research staff and other CCI faculty.
Other:
6.1 Complies with all system and departmental policies and procedures; i.e., completes all related documentation.
6.2 Attends annual mandatory in-services.
6.3 Works efficiently, is flexible and sets priorities.
6.4 Maintains active and current professional credentials.
6.5 Back-up other research staff during vacations, etc. when qualified by education and credentials.
6.6 Performs other duties and functions necessary for the maintenance of efficient, economic and quality operation of the department and system.
6.7 Performs all related duties or special projects as assigned/required.
6.8 Is a participating member of the Research review Committee
6.9 Acts as a liaison/instructor for research staff for utilization of EPIC
Experience Required
0-2 Years Required
Minimum of 2 years Nursing experience required with oncology experience preferred.
Minimum of 2 years research experience preferred
Program Development experience preferred
Education Requirements
Bachelor's degree in nursing
Salary Min ($) USD $40.00 Salary Max ($) USD $64.00
$51k-75k yearly est. Auto-Apply 60d+ ago
Research Coordinator PRN - Neurology
Cooper University Hospital 4.6
Camden, NJ jobs
About Us
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description
The Research Coordinator will independently manage key aspects of sponsored and investigator-initiated trials within Cooper Neurological Institute. This includes project planning, scheduling and administering research study activities, and ensuring that study protocols and regulatory requirements are followed.
Experience Required
3-5 years' experience preferred
Education Requirements
Bachelor's Degree required.
Master's Degree preferred.
License/Certification Requirements
Certified Clinical Research Professional preferred.
Salary Min ($) USD $36.00 Salary Max ($) USD $59.00
$48k-68k yearly est. Auto-Apply 49d ago
Clinical Research Coordinator
Astera Cancer Care 4.0
East Brunswick, NJ jobs
Why Join Us?
For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities within New Jersey and Pennsylvania. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve.
Job Description:
As an Oncology Clinical Research Coordinator (CRC), you will be an integral part of studies at Astera Cancer Care by recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position.
Responsibilities Include:
Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the Astera research program.
Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs.
Assist in the coordination of tests and visits for patients and collaborate with the Astera study team to maximize work efficiency and productivity.
Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol.
Work with researchnurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.
Maintain patient and regulatory research records.
Confer with all members of the clinical team to confirm appropriateness and timeliness of tests.
Collect follow-up data on patient's post-treatment as required by the protocol.
Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status.
Enter research data into a centralized database as per protocol requirements.
Attend investigator meetings as required or requested by the Principal Investigator.
Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs.
If applicable, able to prepare blinded and unblinded study drugs.
If applicable, act as primary coordinators for unblinded team.
Qualifications:
A Bachelor's degree or equivalent working experience required.
Pharmacy Technician certified with infusion drug preparation training preferred.
At least one (1) year of clinical research experience, Oncology experience a plus.
Experience in Oncology Patient Recruitment and retention skills.
Experience with EDC, IWRS. CRF and Microsoft applications.
Able to travel between offices within the offices in Northeast Jersey area.
Excellent communication skills.
Excellent time management skills.
$52k-75k yearly est. Auto-Apply 46d ago
Clinical Research Coordinator
Hackensack University Medical Center 4.5
Research nurse job at Hackensack Meridian Health
Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.
Responsibilities
A day in the life of a Clinical Research Coordinator at Hackensack Meridian Health includes:
* Acts as liaison between principal investigators, sub-investigators, clinical researchnurses and regulatory specialists on all regulatory issues and changes within the protocol.
* In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
* Reviews study with principal investigator and/or clinical researchnurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
* Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
* Coordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required.
* Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary.
* Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
* Monitors all study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
* Registers protocol patients with appropriate statistical centers as required.
* Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
* Acts as principal investigator`s representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.
* Along with clinical researchnurses, maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
* Works closely with clinical research finance to ensure study patient`s clinical trial related activities are billed appropriately.
* Schedules, coordinates, prepares, and assists for all sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.
* Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
* Ensures compliant maintenance of all required records of study activity including case report forms, drug dispensation records, or regulatory forms.
* Oversees and directs the requisition, collection, labeling, storage, or shipment of specimens.
* Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
* Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
* Identifies protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
* Organizes space for study equipment and supplies.
* Participates in the development of study protocols including guidelines for administration or data collection procedures
* Contacts outside health care providers and communicate with subjects to obtain follow-up information.
* Reviews scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
* Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
* Attends research meetings and conferences as required.
* Participates in staff meetings and in-service education as necessary.
* Other duties and/or projects as assigned.
* Adheres to HMH Organizational competencies and standard of behavior.
Qualifications
Education, Knowledge, Skills and Abilities Required:
* BA/BS diploma/degree in science or healthcare field.
* Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
* Strong attention to detail and customer service focus.
* Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
* Excellent organizational, presentation, documentation and interpersonal skills.
* Excellent written and verbal communication skills.
* Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
Education, Knowledge, Skills and Abilities Preferred:
* Education on human subject research and GCP.
Licenses and Certifications Preferred:
* SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
Compensation
Minimum rate of $78,395.20 Annually
HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:
* Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
* Experience: Years of relevant work experience.
* Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
* Skills: Demonstrated proficiency in relevant skills and competencies.
* Geographic Location: Cost of living and market rates for the specific location.
* Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
* Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.
Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.
In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
Our Network
Hackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.
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