clinical trial nurse

Tennessee Oncology

<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p>Tennessee Oncology, one of the nation&rsquo;s largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology&rsquo;s mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.</p></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><p></p><p>
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.</p><p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Job Description:</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div><p>
As the Research Nurse for Tennessee Oncology your primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for source documentation and recording of adverse events. You are also responsible for dispensing oral investigational products and ensuring patient compliance with these medications</p><p><b>
ESSENTIAL FUNCTIONS:</b></p><ul><li>
You will be enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.</li><li>
Obtains and maintains informed consents of each patient for the duration of a study</li><li>
You will review the study design and inclusion/exclusion criteria with physician and patient.</li><li>
You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements.</li><li>
You will complete and document screening/eligibility accurately.</li><li>
You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization.</li><li>
You will accurately complete and submit on-study forms within required timelines</li><li>
You will document all specific tools required by the protocol (i.e., oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)</li><li>
You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs</li><li>
You will ensure that patient documentation is completed at each clinic visit while in screening.</li><li>
You will ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.</li><li>
You will accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.</li><li>
You will ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.</li><li>
You will document appropriately when patients are removed from protocol.</li><li>
You will ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately</li><li>
provides patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment.</li><li>
maintains medication inventory and reconciliation</li></ul><p></p><p><b>
KNOWLEDGE, SKILLS &amp; ABILITIES:</b></p><ul><li>
Knowledge of medical and research terminology</li><li>
Knowledge of FDA Code of Federal Regulations and GCP</li><li>
Knowledge of the clinical research processes</li><li>
At least one year of oncology experience, preferably hematology and/or transplant.</li><li>
At least one year of experience in a research setting preferred</li><li>
Research Certification (ACRP or CCRP) Preferred</li></ul><p></p><p><b>
EDUCATION &amp; EXPERIENCE:</b></p><ul><li>
An Associate Degree; preferably a bachelor&rsquo;s degree</li><li>
RN License</li></ul></div><p></p>

Research Nurse

Parexel

<div><p><b>Parexel Early Phase Clinical Unit </b>supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and &ldquo;first in human&rdquo; trials are the first step in testing these novel treatments in humans.</p><div><p><b><br>
At Parexel Baltimore Unit</b> our highly trained and skilled nurses are the front-line staff involved in administering these new compounds to our volunteer participants via multiple routes, including, but not limited to, IV, IM, SC, PO, Topical, Inhalation etc. Then monitor the volunteer participants health status around the clock as per the trial protocol to ensure their safety and wellbeing.</p><p></p><p>
Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.</p><p></p><p><b>
What you&rsquo;ll do after training is completed (including but not limited):</b></p><ul><li>
Support Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).</li><li>
Assume responsibility for patient care and study conduct assignments.</li><li>
Ensure that all study laboratory and medical tests are completed, and that eligibility requirements specific to the assigned study are met. Assess compliance, symptoms, etc. per study protocol. Arrange for pre/post procedure laboratory work to be performed.</li><li>
Ensure that all established timelines relating to areas of responsibility and assigned projects are met.</li><li>
Participate and may direct identification and enrollment of study participants. Contributes to the development and implementation of study/research objectives.</li><li>
Assess, monitor, record, and report patient&rsquo;s condition and reaction to drugs and treatments to the appropriate physician.</li><li>
Collect and prepare data. Organize and enter data into case report forms.</li><li>
Enter data into databases when required. Assist physicians in completing flow sheets in medical records and progress notes. Update and maintain the contents of the Clinical Study File.</li><li>
Perform or arrange for phlebotomy, urine collection, sample preparation, storage and shipment of samples, drug dispensing, and follows GCP quality study documentation.</li><li>
Act as participant advocate in the conduct of clinical studies.</li></ul><p></p><p><b>
Qualifications</b></p><ul><li>
At least 2 years working in a hospital or clinical setting</li><li>
BSN preferred or relevant work experience.</li><li>
Active Registered Nurse License in the state of Maryland</li><li>
Current Basic Life Support (BLS) certification.</li><li>
ACLS certification required within 6 months of start date</li></ul><p></p><p>
Base Pay Range: $40.00 to $45.00 per hour</p><p></p><p>
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.</p><p></p><p>
In addition to base salary, some roles may be eligible for participation in Parexel&rsquo;s annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.</p><p></p><p>
Parexel is dedicated to supporting, developing and retaining a diverse workforce, inclusive of veteran and military spouse talent. The skills and values you have developed are transferrable to meaningful careers here at Parexel. The following military career roles align with this position 66G, 66H, 68C, 4NOX1, 46NX, 66S, 66T, 290X.</p></div></div>

Clinical Research Nurse (RN) - Per Diem

Alcanza Clinical Research

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.<br>
<br>
The <b>Clinical Research Nurse </b>works to ensure the execution of assigned studies, and performs clinical procedures, such as venipunctures, injections, prep or mixing of investigational study drugs and infusions, under the scope of the study protocol and in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.</div><h3 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h3><div><br>
<b>
Essential Job Duties: </b>In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:</div><ul><li>
Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes &amp; procedures, and in compliance with FDA, GCP, ICH regulations and guidelines:<ul>
<li>Screening of patients for study enrollment;</li>
<li>Patient consents;</li>
<li>Patient follow-up visits;</li>
<li>Documenting in source clinic charts;</li>
<li>Entering data in EDC and answers queries;</li>
<li>Starting IVs</li>
<li>Obtaining vital signs and ECGs;</li>
<li>May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;</li>
<li>Performing procedures commensurate with licensure including vitals, ECGs/EKGs, venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.</li>
<li>Requesting and tracking medical record requests;</li>
<li>Updating and maintaining logs, chart filings;</li>
<li>Maintaining &amp; ordering study specific supplies;</li>
<li>Scheduling subjects for study visits and conducts appointment reminders;</li>
<li>Building/updating source as needed;</li>
<li>Conducting monitoring visits and resolves issues as needed in a timely manner;</li>
<li>Ensuring study related reports and patient results are reviewed by investigator in a timely manner;</li>
</ul></li></ul><div>o Filing SAE/Deviation reports to Sponsor and IRB as needed;</div><div>
o Documenting and reporting adverse events;</div><div>
o Reporting non-compliance to appropriate staff in timely manner;</div><div>
o Maintaining positive and effective communication with clients and team members;</div><div>
o Always practicing ALCOAC principles with all documentation;<br>
</div><ul>
<li>Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;</li>
<li>Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;</li>
<li>Prepare and attend site initiation visits (SIV&rsquo;s) and Investigator Meetings (IMs), as needed;</li>
<li>May set up, train and maintain all technology needed for studies.</li>
<li>May assist with study recruitment, patient enrollment, and tracking as needed;</li>
<li>Maintaining confidentiality of patients, customers and company information, and;</li>
<li>Performing all other duties as requested or assigned.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Skills, Knowledge and Expertise</b></h3><div><br>
<b>
Minimum Qualifications</b>: A Bachelor&rsquo;s degree in Nursing (BSN) AND a minimum of 1 year of clinical experience, OR an equivalent combination of education and experience, is required. An active, unrestricted RN license, in state of work location, is required. BLS certification required. Bi-lingual (English / Spanish) proficiency is a plus.
 <br>
<br>
<b>Required Skills:</b>
</div><ul><li>Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);</li>
<li>Proficiency with performing clinical procedures such as injections, vitals, EKGs, phlebotomy, infusions, etc. is required.</li>
<li>Strong organizational skills and attention to detail.</li>
<li>Well-developed written and verbal communication skills.</li>
<li>Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.</li>
<li>Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.</li>
<li>Must be professional, respectful of others, self-motivated, and have a strong work ethic.</li>
<li>Must possess a high degree of integrity and dependability.</li>
<li>Ability to work under minimal supervision, identify problems and implement solutions.</li>
<li>Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Benefits</b></h3><br>
<ul>
<li>
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.</li>
<li>Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.</li></ul><br>
<h3 class="jobSectionHeader"><b>
About Alcanza Clinical Research</b></h3><div>
Alcanza Clinical Research (&ldquo;Alcanza&rdquo;) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
<br>
<br>
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
<br>
<br>
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
<br>
<br>
<b>Alcanza Clinical Research is an Equal Opportunity Employer</b> that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.</div></div>

Clinical Research Registered Nurse

Cancer Specialists of North Florida

<div><div><div><div><div><div><p><b><i>Cancer Specialists of North Florida</i></b> is recruiting for an experienced<b><i> Clinical Research Manager </i></b>for our busy practice. The Research Clinical Manager is responsible for the coordination of all research activities throughout the organization. This position is responsible for managing the administration of clinical trials and the clinical trial monitoring process. Duties include oversight of patients for clinical trials, presenting trial concepts and details to patients, providing education for staff and patients, and ensuring proper treatment for and assuming responsibility for clinical documentation for patients on protocol. In addition to this, the Manager acts to provide guidance and oversight for the research department and to ensure proper execution of clinical trials by all research employees. Essential duties and responsibilities include the following:</p><ul><li>
Obtain and review trials for participation upon research committee&rsquo;s approval; initiates study protocol by oversight of required regulatory documents submission.</li><li>
Responsible for oversight of research business operations including; departmental budgets, financial planning and tracking infrastructures, as well as protocol specific budgetary and contractual negotiations with pharmaceutical companies.</li><li>
Coordinates payment of provided study procedures and ensures accurate data collection in a timely manner to the sponsor.</li><li>
Maintains protocol regulatory documents for compliance with Institutional Review Board, including renewal, amendments and submissions of new protocols.</li><li>
Oversees clinical operations for research department including drug accountability, storage &amp; handling and proper mixing procedures.</li><li>
Maintains a sound plan for organization and recommends changes as needed due to growth and development of the research department.</li><li>
Holds and coordinates training for research personnel for a maximum service to patients in accordance with policies and procedures.</li><li>
Acts as a resource for clinical staff and patients regarding questions of protocol studies.</li><li>
Reports protocol activities, monthly accrual reports at meetings.</li><li>
Promotes and educate clinical staff on the protocol studies available to patient enrollment</li><li>
Develops and establishment of policies and procedures. Ensures their adequate execution, compliance and updates.</li><li>
Ensures all research activities are carried out in compliance with organizational policies, procedures, and governmental laws and regulations.</li><li>
Maintains strict patient confidentiality at all times.</li><li>
Special projects as assigned.</li></ul><p>
Full Time Position, Monday - Friday</p><p><b>
Location Address:</b> 7751 Belfort Parkway, Jacksonville, FL 32256</p><p><b>
Education and Experience:</b></p><ul><li>
Graduated from a four year accredited program.</li><li>
Minimum of seven years of oncology experience with chemotherapy and research experience</li><li>
Minimum of two years of management experience</li></ul><p><b>
Certificates, Licenses, Registrations:</b></p><ul><li>
Current licensure as a registered nurse or pharmacist in state of practice preferred</li><li>
Current BLCS certification required</li><li>
SOCRA or ACRP certification preferred</li></ul><p><b>
Compensation and Benefits:</b></p><ul><li>
Salary is commensurate with experience and qualifications</li></ul><p>
Cancer Specialists of North Florida is an &quot;EEO Employer&rdquo; and &ldquo;Drug Free Workplace&rdquo;</p></div></div></div></div></div></div>

Clinical Research Manager

Mass General Brigham

<div>Site: The General Hospital Corporation<br>
<p></p><br>
<p>Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.<br>
</p><p></p><br>
Research Nurse Coordinator &ndash; Leukemia
<br>
<br>
Current MA RN license required.
<br>
BSN preferred
<br>
Oncology Nursing experience, Min. 2yrs required
<br>
Supportive Nursing Leadership, competitive pay and great benefits!
<br>
The Mass General Cancer Center Protocol Office (CCPO) conducts multi-phase studies in the outpatient setting at the MGH Cancer Center.
<br>
If you want to be on the cutting edge of discovering new cancer therapies, the CCPO is a wonderful place to work.
<br>
Leukemia Research Nurses play a vital role in supporting clinical trials and advancing innovative leukemia cancer treatments. In this position, you will manage study protocols and work collaboratively with research nurse reviewers, clinical research coordinators, physicians, advanced practice providers, and regulatory team members.
<br>
You will be instrumental in translating groundbreaking clinical trial concepts into practical care for patients. By building strong relationships with patients, you&rsquo;ll provide comprehensive education, triage, support, and guidance to help them prepare for and navigate the clinical trial experience, making a meaningful impact on cancer care and outcomes!
<br>
Two years RN experience required. Oncology and/or Research nursing experience preferred.
<br>
<br>
M-F, 7am-5:30pm, set schedule with possibility of one remote day per week after 6 months in the role and subject to clinic needs.
<br>
<br>
CCPO Research Nurses are responsible for screening and enrolling patients for trials, patient education, triage phone support for patients in between treatment visits, symptom management, expert knowledge of protocols, meticulous documentation, and strong advocacy for patients while they are on trial.
<br>
CCPO Research nurses work closely with Infusion RNs, APPs and Physicians within the Cancer Center to support patients on clinical trials and to meticulously adhere to the protocol.
<br>
Research RNs support the organizational mission and the Cancer Center investment in clinical research and making clinical trials accessible to more patients from diverse and underserved communities.
<br>
<br>
Supported by a Nursing Director, Nurse Managers and Nursing Practice Specialists, this team is responsible for establishing standards of care, initiating quality improvement projects, and setting and supporting the overall tone for excellent patient care.
<br>
<br>
Acts as a resource to the multi-disciplinary care team related to protocol specifications such as administration guidelines for investigational agents.
<br>
<br>
Documents research nurse encounters in the medical record including patient education, required protocol assessments including adverse events, oral study drug adherence, protocol deviations, phone encounters and follow-up.
<br>
<br>
We are also committed to providing our employees with a work-life balance that allows them to thrive both professionally and personally. If you are looking for a challenging and rewarding career in medicine, then Mass General Hospital is the place for you. We offer a variety of career opportunities, so you can find a position that fits your interests and skills. We also offer several benefits, so you can be sure that you are well-compensated for your hard work.
<br>
Reasons to Choose MGH
<br>
1. The State&rsquo;s First Magnet Hospital
<br>
2. Opportunities for growth and development
<br>
3. Medical, Dental and Vision insurance
<br>
4. Tuition Reimbursement
<br>
5. Generous paid time off
<br>
6. Subsidized MBTA pass (50% discount)
<br>
7. Free parking for nights and weekends
<br>
8. Resources for childcare and emergency backup care
<br>
9. Hospital paid retirement plan and tax-sheltered annuity plan.
<br>
10. Employee &ldquo;Perks&rdquo; - enjoy discounts on tickets and passes for everything
<br>
from ski resorts to museums to sporting events.
<br>
<br>
If this sounds like the ideal environment for your skills, we invite you to join us.<br>
<p></p><br>
<p><b>Job Summary
</b></p>Job Description Summary
<br>
Summary
<br>
Accountable for interpreting the plan of medical care, assessment of patients' clinical decision-making regarding nursing care, assuring nursing care is provided in a safe and competent manner, providing individualized nursing care, and evaluating nursing care for groups of patients.
<br>
<br>
Does this position require Patient Care?
<br>
Yes
<br>
<br>
Essential Functions
<br>
<ul><li>Maintain accurate, detailed reports, and records.
</li></ul><br>
<ul><li>Administer medications to patients and monitor patients for reactions or side effects.
</li></ul><br>
<ul><li>Record patients' medical information and vital signs.
</li></ul><br>
<ul><li>Monitor, record, and report symptoms or changes in patients' conditions.
</li></ul><br>
<ul><li>Consult and coordinate with healthcare team members to assess, plan, implement, or evaluate patient care plans.
</li></ul><br>
<ul><li>Modify patient treatment plans as indicated by patients' responses and conditions.<br>
</li></ul><p></p><br>
<div><div><div><div><div><div><div><p><b>Qualifications
</b></p></div></div></div></div></div></div></div><p>Job Description
</p><div>Education
<br>
Associate's Degree Nursing required or Bachelor's Degree Nursing preferred
<br>
<br>
Can this role accept experience in lieu of a degree?
<br>
No
<br>
<br>
Licenses and Credentials
<br>
Registered Nurse [RN - State License] - Generic - HR Only required
<br>
<br>
Experience
<br>
Clinical nursing experience 0-1 year required
<br>
<br>
Knowledge, Skills and Abilities
<br>
<ul><li>Familiarity with the principles and skills needed for practical nursing to provide patient care and treatment.
</li><li>Knowledgeable of the care required by respective age groups for which care is being provided.
</li><li>Ability to maintain confidentiality and secure sensitive information.
</li><li>Knowledge of medical terminology.
</li><li>Excellent verbal and communication skills.
</li><li>Ability to accurately screen and triage acute patients.<br>
</li></ul></div><p></p><br>
<div><div><div><div><div><div><div><p><b>Additional Job Details (if applicable)<br>
</b></p></div></div></div></div></div></div></div><p></p><br>
<div><div><div><div><div><div><div><p><b>Remote Type
</b></p></div></div></div></div></div></div></div>Onsite<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Location
</b></p></div></div></div></div></div></div></div>55 Fruit Street<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Scheduled Weekly Hours
</b></p></div></div></div></div></div></div></div>36<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Employee Type
</b></p></div></div></div></div></div></div></div>Regular<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Shift
</b></p></div></div></div></div></div></div></div>Day (United States of America)<br>
<p></p><br>
<p><b>Pay Range
</b></p>$41.72 - $105.65/Hourly<br>
<p></p><br>
<p><b>Grade
</b></p>GHCARN055<br>
<p></p><br>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>EEO Statement:
</b></p></div></div></div></div></div></div></div>1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<br>
<p></p><br>
<h2 class="jobSectionHeader"><b>Mass General Brigham Competency Framework
</b></h2><div><div><p>At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Research Nurse Leukemia-MGH

Atrium Health

<p></p><div><p><b>Department:</b></p>
85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence<p></p><p><b><br>
Status:</b>
</p>Full time<p></p><p><b><br>
Benefits Eligible:</b></p>
Yes<p></p><p><b><br>
Hou</b><b>rs Per Week:</b></p>
40<p></p><p><b><br>
Schedule Details/Additional Information:</b></p><p>
Regular</p><p></p><p><b>
Pay Range</b></p>
$43.30 - $64.95<p></p><p><b>
JOB SUMMARY</b></p><p></p><p>
The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence. The Clinical Trial Methods Center (CTMC) has been established within the Wake Forest University School of Medicine to provide the necessary tools and expertise that the NCCT will access and apply to deliver many of its core services.</p><p>
This position will be part of a team that will report to leadership in the NCCT and will provide overall management of the operational team and will provide study oversight project management for specific trials as needed.</p><p></p><p><b>
EDUCATION/EXPERIENCE</b></p><p></p><p>
Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or an equivalent combination of education and experience. Significant experience in managing clinical trial teams at a service line, therapeutic area or at a site level.</p><p></p><p><b>
ESSENTIAL FUNCTIONS</b></p><p></p><p>
This position will serve as a working manager who manages: Study Start-Up Navigators (SSUNs), Study Feasibility Project Managers (SFPMs) and Study Oversight Project Managers (SOPMs); and will also provide study oversight project management for specific trials as needed.
</p><p></p><p>I. Manager over Study Start-Up Navigators, Study Feasibility Project Managers and Study Oversight Project Managers who perform the following activities:</p><p></p><p><b>
Trial Navigation:</b> SSUNs serve as central point of contact for sponsors and study teams from first contact through trial activation, gather necessary information from sponsors and functional areas for trial feasibility assessments and trial activation, initiate trials in research systems, provide information to regulatory, budgeting and contracting teams for rapid trial start-up.</p><p></p><p><b>
Trial Feasibility Analyses: </b><b>SFPMs work</b><b> c</b>losely with local study teams, ancillary service providers and with informatics, recruitment and IT functional areas to render informed decisions as to whether the AHNCCT should take on specific trials.</p><p></p><p><b>
Study Oversight Services: </b>SOPMs serve as central points of contact for sponsors and study teams from trial activation through trial closeout. SOPMs facilitate set up of trials and can provide oversight of multisite trials, link local study teams to recruitment, informatics, budget/contracting, regulatory and IT teams. In addition, they can deploy 3rd party clinical trial coordinators to back up local study teams as needed.</p><p></p><p>
II. Study Oversight Project Management</p><p>
Study Oversight Manager helps to set up, monitor and manages the overall progress of trials.</p><ul><li>
Facilitates set up of trials at sites</li><li>
Facilitates and attends site initiation visits.</li><li>
Responsible for outreach to applicable physicians, care teams, etc to gain valuable information.</li><li>
Maintain working knowledge of clinical trials within research portfolio.</li><li>
Connects study staff members with training resources as necessary for compliance with policies.</li><li>
Monitors progress of the clinical trial until completion ensuring accrual, study activities and quality measures are met.</li><li>
Mitigates issues as they arise (e.g., difficulty meeting enrollment targets, etc.)</li><li>
Liaises with regulatory to monitor amendments, personnel changes, etc.</li><li>
Liaises with sponsor, investigator(s) and site staff throughout trial.</li><li>
Monitors resource demands throughout trial.</li><li>
Supports the deployment of coordinators and Advanced Care Providers to sites as needed for study conduct.</li></ul><p></p><p>
III. Performs other related duties incidental to the work described herein.</p><p></p><p><b>
SKILLS/QUALIFICATIONS</b></p><p>
Excellent verbal and written communication skills. Ability to work independently to develop processes. Ability to travel to affiliate sites and central offices as needed. Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices.</p><p></p><p><b>
Our Commitment to You:</b></p><p></p><p>
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more &ndash; so you can live fully at and away from work, including:</p><p></p><p><b>
Compensation</b></p><ul><li>
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training</li><li>
Premium pay such as shift, on call, and more based on a teammate's job</li><li>
Incentive pay for select positions</li><li>
Opportunity for annual increases based on performance</li></ul><p></p><p><b>
Benefits and more</b></p><ul><li>
Paid Time Off programs</li><li>
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability</li><li>
Flexible Spending Accounts for eligible health care and dependent care expenses</li><li>
Family benefits such as adoption assistance and paid parental leave</li><li>
Defined contribution retirement plans with employer match and other financial wellness programs</li><li>
Educational Assistance Program</li></ul><p></p><p><b><br>
About Advocate Health</b></p><p></p><p>
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation&rsquo;s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.</p><p>
</p>Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.</div>

National Center for Clinical Trials (NCCT) Clinical Trial Facilitation Manager

Minerva Research Solutions

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  JOB DESCRIPTION:
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 </strong>
 Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
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 Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.
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 We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
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 Minerva Research Solution is looking for dynamic individuals with a passion for ensuring the highest standards in clinical trial data quality assurance. As a key player in our team, you will play a crucial role in maintaining the integrity and accuracy of clinical trial data.
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  Responsibilities:
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 </strong>
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   Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness
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   Ensure data is recorded under sponsor protocol, GCP guidelines, industry guidelines, and agency regulations
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   Perform quality control checks; identify and track source documentation errors and non-conformances with requirements
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   Provide ongoing compliance support including but not limited to:
  </li>
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   Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans
  </li>
  <li>
   Collaborating with the Clinical Team to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs)
  </li>
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   Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities
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   Assist in preparing for all Sponsor and FDA audits
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   Assist in conducting internal audits to review key processes
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   Provide appropriate support to assigned cross-functional workgroups
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   Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement
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   Query resolution and data entry and questionnaire preparation regarding the respective studies
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   Other related Quality Assurance projects as assigned
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   The QA Associate will report to the Quality Assurance Lead
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  </li>
 </ul>
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  Knowledge, Education, and Experience:
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 </strong>
 <ul>
  <li>
   Qualified Profession with strong medical background (Pharm-D, MBBS, BDS etc) with a keen interest in Clinical Research are strongly encouraged to apply
  </li>
  <li>
   In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials
  </li>
  <li>
   Knowledge of IRB requirements
  </li>
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   1+ years in work related to Quality Control / Quality Assurance area in clinical research will preferred.
  </li>
  <li>
   Experience including external clinical/regulatory and document auditing will be a plus
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  </li>
 </ul>
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  Skills and Abilities:
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 </strong>
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  <li>
   Good communication skills (interpersonal, written, verbal)
  </li>
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   Strong attention to detail and good time management skills
  </li>
  <li>
   Flexible attitude concerning work assignments
  </li>
  <li>
   Ability to manage multiple and varied tasks in a fast-moving environment
  </li>
  <li>
   Ability to interact professionally at all levels within the organization
  </li>
  <li>
   Knowledge of the HIPAA Privacy Act and its application to clinical research
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   <br/>
  </li>
 </ul>
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  Benefits:
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  <br/>
 </strong>
 <ul>
  <li>
   Competitive salary and performance-based bonuses
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   Medical health insurance coverage
  </li>
  <li>
   Employees Old-age benefits coverage
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   Flexible work hours and remote work options
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  <li>
   Professional learning and development support
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  <li>
   Generous vacation and paid time off
  </li>
  <li>
   Employee assistance programs for mental health
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  <li>
   Company-sponsored events and team-building activities
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  <li>
   Diverse, professional, and inclusive work environment
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   Opportunities for career growth
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   Cutting-edge technology and tools
  </li>
  <li>
   Family-friendly policies, including parental leave
  </li>
  <li>
   Commuter benefits or transportation assistance
  </li>
  <li>
   Social responsibility and community involvement programs
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   <br/>
  </li>
 </ul>
 <strong>
  Openings:
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  <br/>
 </strong>
 04 positions
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 <br/>
 Full-time
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 <br/>
 On-site job
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 <strong>
  Work Schedule Timings:
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 </strong>
 Monday to Friday
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 <br/>
 Evening Shift (07 PM to 03 AM)
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 <br/>
 (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
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Clinical Trials Quality Assurance Associate (Night)

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