clinical trial investigator

Alcanza Clinical Research

<div><h3 class="jobSectionHeader">Description</h3><div> 
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.
 
 
The Principal Investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Working with a local and central team drives clinical oversight and the quality of the assigned studies at the site.</div><h3 class="jobSectionHeader"> 
Key Responsibilities</h3><div> 
Essential Job Duties:</div><ul>
<li>Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs &amp; HIPAA guidelines, study protocols, as well as company policies and processes</li>
<li>Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP /regulatory compliance</li>
<li>Evaluates and assesses participants to ensure only eligible participants enroll into the trials.</li>
<li>Participates and engages in successful delivery and retention of study participants.</li>
<li>Interacts positively and collaboratively with sponsors, clients and team members.</li>
<li>Practices attention to detail in recording data and participant information, following protocol guidelines and GCPs.</li>
<li>Actively involved in protocol training for staff.</li>
<li>Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current knowledge of recruitment affairs and issues.</li>
<li>Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company.</li></ul><div></div><h3 class="jobSectionHeader"> 
Skills, Knowledge and Expertise</h3><div> 

Minimum Qualifications: MD or DO degree, an active physician license (in good standing) in the state of practice for this role is required. Clinical Research experience is required. Board certification in neurology is required. 
</div><div>Required Skills:</div><ul>
<li>Clinical procedures based on area of specialty.</li>
<li>Proficiency with computer applications such as MS Office, electronic health records, and web applications, and the ability to type proficiently (40+ wpm).</li>
<li>Must possess strong organizational skills, attention to detail, and math proficiency.</li>
<li>Well-developed written and verbal communication skills. Bi-lingual (English / Spanish) proficiency is highly preferred.</li>
<li>Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, employees, subjects, managers and external customers.</li>
<li>Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.</li>
<li>Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic.</li>
<li>Must possess a high degree of urgency, self-motivation, integrity and dependability.</li>
<li>Ability to work independently to 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><div></div><h3 class="jobSectionHeader"> 
Benefits</h3> 
<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> 
<h3 class="jobSectionHeader">
About Alcanza Clinical Research</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.
 
 
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.
 
 
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.
 
 
Alcanza Clinical Research is an Equal Opportunity Employer 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 Principal Investigator - Neurologist

City of Hope

<div><div><div><div><div><div><div><div><div>Clinical Study Coordinator - Clinical Research (On-Site-Duarte,CA)</div><div>
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope&rsquo;s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.</div><div>
Duarte Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials. Under the supervision of the Director, Clinical Research, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials. Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance. The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.</div><div>
As a successful candidate, you will:</div><ul><li>
Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.</li><li>
Follow and execute clinical trial protocols and procedures.</li><li>
Coordinate participant recruitment, informed consent, and care.</li><li>
Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.</li><li>
Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.</li><li>
Pursue continuous education and training opportunities, staying updated with the latest clinical research information, and maintain necessary certifications and licensure.</li></ul></div></div></div></div></div></div></div><div></div><div><div><div>
Your qualifications should include:</div><ul><li>
Bachelor&rsquo;s degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.</li><li>
Minimum of 2 years research or relevant clinical experience</li><li>
ACRP or SOCRA certification within 1 year of employment</li><li>
International Air Transport Association (IATA) within 1 month of employment</li><li>
Good Clinical Practice (GCP) within 1 month of employment</li><li>
Human Subjects Protection (HSP) within 1 month of employment</li><li>
Basic Life Support (BLS) within 1 month of employment</li></ul><div>
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.</div><div>
To learn more about our Comprehensive Benefits, please CLICK HERE.</div></div></div></div>

Clinical Study Coordinator

VCU Health System

<div>The Clinical Research Coordinator II is responsible for all aspects of conducting Phase I, II, III, and IV clinical trials for children, adult, and/or geriatric patients within internationally accepted standards of knowledge and understanding of the clinical research process and related regulations. The position duties include administrative and clinical study initiation processes, enrollment of patients, data collection, managing study patient follow-up, coordination of monitoring visits, and other administrative duties. The CRC II will also be a resource on general and VCU Health/VCU-specific clinical research processes for junior clinical research staff as well as University and health system staff.
Essential Job functions
Performance Expectation: Exhibit advanced competencies required to conduct clinical research 
Maintains an intermediate knowledge and understanding of the research process and related regulations; 
Maintains CCRC certification; 
Maintains membership in one (1) professional organization or hospital committee or high-profile activity; 
Maintains an intermediate level of knowledge including anatomy, disease process, medical terminology, tests and procedures relating to area of responsibility; 
Receives a minimum of 24 contact hours per year related to clinical research or job-related discipline documented by certificates of continuing education credits; 
Exhibits a high skill level of Microsoft Office and enrolls in classes as needed to achieve this level; 
Exhibits a high level of proficiency in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements; 
Develops a system for organizing, planning and controlling work-flow as related to specific activities with meticulous attention to detail and ordering of priorities; and 
Proven to function independently and proficiently as defined in the position essential functions with minimal supervision.
Performance Expectation: Initiates studies 
Coordinates and facilitates site qualification visits; 
Assists in evaluation of all potential clinical research studies; 
Exhibits a working knowledge of the protocol, including background, rationale and description of investigational drug/device; 
Understands inclusion/exclusion criteria; 
Understands visits, tests, procedures and concomitant medications per protocol; 
Knowledgeable and confident to perform informed consent process including multiple consenting when appropriate; 
Maintains communication with sponsor representatives, including acquisition of case report forms, device and/or drug stock, study tools and related documents; 
Maintains current inventory logs; 
Identifies study specific tests and procedure protocols, contacts appropriate departments and facilitates required training, certification and validation; 
Coordinates and facilitates site initiation visits; 
Assesses protocol requirements for patient care and provides necessary instruction; 
Collaborates with principal investigator to identify standard of care vs. nonstandard of care visits, hospitalizations, tests and procedures; 
Assembles, updates and maintains study packets, including consent, inclusion/exclusion check list, sponsor contact information and other related information; 
Prepares and distributes study specific flyers for ancillary staff and departments; 
Coordinates in-service/training/proctoring for physicians, departments and appropriate staff with supervision; and 
Ensures accurate progress of the protocol from planning to closure. 
 
Performance Expectation: Enrolls patients 
Diligently screens for patients in appropriate departments and participating physician offices; 
Completes and submits screening forms; 
Enters screen failures in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements; 
Maintains contact with principal investigators and sub-investigators to promote study and encourage patient enrollment; 
Available and prepared for patient enrollment; 
Promotes protocol compliance by being in clinic/physician&rsquo;s office/lab/OR when the subject is seen or leaves guidelines for investigator or sub-investigator to follow; 
Notifies and schedules sponsor clinicians, engineers and/or proctors for cases as necessary; 
Orders all protocol required labs, tests, procedures and medications accurately and according to VCU Health/VCU and area of responsibility SOPs; 
Manages studies prospectively to prevent protocol deviations; 
Enters patient enrollments and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements; 
Communicates regularly with PI, research nurse, and RCII team to ensure smooth and accurate enrollments; and 
Maintains screening and enrollment logs and provides to sponsor within established timeframe.
Performance Expectation: Collects data 
Knowledgeable of both electronic and paper case report forms and procedures for completion and correction; 
Ensures all study documentation is accurately maintained, utilizing sponsor source documents or develops source documents as necessary; 
Completes case report forms at time of enrollment and at follow-up visits with appropriate source documentation; 
Returns case report forms to study sponsor in a timely manner; 
Responds to data clarification requests adequately and in a timely manner; 
Maintains a log of outstanding queries; 
Maintains confidentiality of Protected Health Information (PHI) and keeps all records secure; 
Requests charts and office notes from referring physicians and investigators to retrieve/capture data; 
Obtains all required signatures in a timely manner; and 
Processes, stores, and ships biospecimens according to local and study specific requirements.
Performance Expectation: Manages study patient follow-up 
Follows study patient both in-patient and out-patient throughout course of study; 
Meets the timetable for protocol procedures and follow-up schedule; 
Ensures patient is scheduled for follow-up appointments; 
Orders all protocol required follow-up labs, tests, procedures and medications accurately and according to area of responsibility SOPs; 
Is present for all follow-up appointments when possible; 
Collects appropriate data during follow-up visit utilizing acceptable source documentation; 
Enters patient follow-up visits and completes check list in the Clinical Trial Management System or other electronic database/management system per VCU Health/VCU requirements; 
Monitors for adverse events, including daily review of study patient hospitalizations; 
Informs patients of changes in protocol and adverse events; re-consents patients as required; 
Makes every attempt to locate patient for follow-up and documents activity appropriately; and 
Collaborates with attending physician and principal investigator to report serious adverse events to study sponsor and regulatory personnel within mandated timeframe.
Performance Expectation: Manages monitoring visits 
Coordinates and schedules monitoring and study close-out visits; 
Schedules conference room, principal investigator, regulatory personnel, pharmacist and other staff in advance for sponsor visit; 
Ensures all data is entered on case report forms; 
Provides source documentation for all data; 
Maintains organized, complete study charts, including legible, accurate research notes; 
Requests and has available all medical records related to study patient; and 
Is available to monitor for clarification and corrections as needed.
Performance Expectation: Communication and Problem-Solving 
Effectively shares and educates university and health system staff regarding the process for management of the segregation and routing of charges related to the treatment of patients enrolled in clinical trials; 
Independently identifies barriers to the segregation process and utilizes appropriate resources to resolve problems and remove barriers; 
Communicates in a timely professional manner with investigators, research staff, colleagues, and university and health system departments; 
Answers pages, phone messages and e-mails in a timely manner documenting communication as necessary; 
Takes the necessary initiative and collaborates with the interdisciplinary team members; 
Coordinates with research study staff and health system departments to identify and interact efficiently to maximize use of health system resources; and 
Capable of anticipating obstacles and proactively developing solutions to achieve identified goals.
Performance Expectation: Additional Responsibilities 
Attends research meetings (e.g., staff, Scientific Review, Protocol Review. etc.); 
Assists in preparing agenda(s) for research meetings; 
Participates in continual learning, Performance Improvement (PI) projects and JCAHO Readiness; 
Functions within the guidelines of VCU Health, VCU, HIPAA, OSHA, JCAHO, federal, state and other regulatory agencies including OPRR, GCP and FDA guidelines; 
Participates in VCU Health/VCU quality assurance programs; 
Acts as liaison and &quot;Good Will Ambassador&quot; between research department, physician practices, hospital and staff; 
Assists in training new CRCs; 
Ensures all regulatory documents and correspondence are submitted to regulatory personnel in a timely manner; 
Meets department screening and accrual goals; 
Assists in recruiting and interviewing potential candidates for research positions; 
Assists in planning and design of new forms/flowsheets to be used in research activities; 
Performs other duties as assigned and/or participates in special projects in order to support the mission of clinical research at VCU Health; 
Provides assistance to team members as needed/requested; 
Accepts alternate assignments, as required, graciously; and 
Completes one (1) special project a year or presentation per year that impact clinical research at VCU Health/VCU.
Patient Population: N/A 
 
Employment Qualifications
Required Education:
Bachelor&rsquo;s degree in Health-related Field
Licensure/Certification Required: None
Licensure/Certification Preferred:
Clinical Certification, and maintenance, of one of the following:<ul><li>
Certified Medical Assistant</li><li>
Certified Nursing Assistant
</li><li>Emergency Medical Technician</li><li>
Paramedic
</li><li>Or equivalent level of certification</li></ul> 
Basic Life Support (BLS) training for Healthcare Professionals
Experience Required: 
Minimum of two (2) years of clinical research experience
Experience Preferred: 
Three (3) years of work experience in clinical research; 
Five (5) years of work experience in disease/discipline; 
Significant previous patient records review and abstraction experience; 
Five (5) years of work experience in a team environment; and 
Experience training research staff.
Cultural Responsiveness:
 
Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. 
 
Working Conditions
Periods of high stress and fluctuating workloads may occur. 
General office environment. 
Prolonged periods of working alone.
Physical Requirements
Lifting/ Carrying (0-50 lbs.), Push/ Pull (0-50 lbs.), Stoop, Kneel, Squat, Balance, Bending 
Work Position: Sitting, Walking, Standing 
Additional Physical Requirements/ Hazards
Physical Requirements: Manual dexterity (eye/hand coordination), Finger Dexterity 
Hazards: none
Mental/Sensory: Reasoning, Problem solving, Speak clearly, Reading, Logical Thinking 
Emotional: Steady pace, Able to handle multiple priorities
EEO Employer/Disabled/Protected Veteran/41 CFR 60-1.4.</div>

Clinical Research Coordinator III

Orlando Health

<div>Position Summary:
<div>
Orlando Health is a 3,200-bed system that includes 15 wholly-owned hospitals and emergency departments; rehabilitation services, cancer institutes, heart institutes, imaging and laboratory services, wound care centers, physician offices for adults and pediatrics, skilled nursing facilities, an in-patient behavioral health facility, home healthcare services in partnership with LHC Group, and urgent care centers in partnership with CareSpot Urgent Care. Nearly 4,200 physicians, representing more than 80 medical specialties and subspecialties have privileges across the Orlando Health system, which employs nearly 22,000 team members. Areas of clinical excellence are orthopedics, heart and vascular, cancer care, neurosciences, surgery, pediatric specialties, neonatology, women&rsquo;s health and trauma</div><div></div><div> 
Successful candidates joining our TEAM will be eligible for:</div><ul><li>
Outstanding Benefits with a 403(B) match for full and part-time employees.</li><li>
Retirement Savings plan.</li><li>
Paid Time Off plan.</li><li>
Education Assistance programs; Tuition reimbursement, Student Loan repayment program, and Preferred Education Program.</li><li>
Maternity leave; 4 weeks yearly.</li><li>
Among many other benefit programs. Benefits do kick in from day one!</li></ul><div></div><div> 
Position Summary
 
Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research.</div><div></div><ul><li> 
Phlebotomy experience a plus</li></ul><div></div><div> 
Seeking individual with a high attention to detail, quick learner, and able to work in a fast-paced environment. Individual must be comfortable working with patient&rsquo;s and in an operating room setting.</div><div></div><div> 
Essential Functions
 
Participate in the coordination of multi-site or large-scale clinical trials research studies conducted by a supervising principal
 
investigator(s) in support of activities that meet objectives of assigned research protocol(s).
 
Assesses patients for protocol eligibility and communicates findings to investigator/physician.
 
Coordinates the implementation of protocol procedures.
 
Operates specialized equipment as needed in assigned area, if applicable.
 
Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
 
Provides appropriate patient and family education.
 
Completes a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and
 
for internal purposes.
 
Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify
 
potential problems and/or inconsistencies and take action as appropriate.
 
Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
 
Provides educational in-services as needed.
 
Promotes interdepartmental cooperation and coordination for each protocol.
 
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other
 
federal, state, and local standards.
 
Maintains compliance with all Orlando Health policies and procedures.
 
Other Related Functions
 
Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
 
Assists the research team in preparing for site audits.
 
Attends appropriate departmental and/or corporate meetings
 
Attends study group and investigator meetings as required.
 
Demonstrates ability in using computer software specific to department.
 
Support the team of data managers by answering complex questions and entering information into the EDC if necessary.</div><div> 
Education/Training
 
Must meet one of the following:
 
Bachelor&rsquo;s degree in health-related field (i.e., Healthcare Administrative, Nursing, Respiratory Therapy, Health &amp; Wellness
 
or Health Information Management); or
 
Associate degree in related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health &amp; Wellness or Health
 
Information Management) and one (1) year of clinical research or healthcare experience (in addition to the requirements
 
listed in the Experience section); or
 
Graduate of an accredited allied health program and one (1) year of clinical research or healthcare experience (in addition
 
to the requirements listed in the Experience section).
 
If no degree, experience may be substituted at a two for one ratio and a minimum of one-year clinical research experience
 
required.</div><div></div><div> 
Licensure/Certification
 
All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the
 
medical director.
 
BLS/Healthcare Provider certification required.</div><div> 
Experience
 
One (1) year of healthcare experience required</div></div><div></div>

Clinical Research Coordinator I - Orlando Health - Corporate - Full Time

Atrium Health

<div>Department:
85296 Wake Forest University Health Sciences - Clinical Trial Methods Center of Excellence 
Status:
Full time 
Benefits Eligible:
Yes 
Hours Per Week:
40 
Schedule Details/Additional Information:
Regular
Pay Range
$43.30 - $64.95
JOB SUMMARY
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.
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.
EDUCATION/EXPERIENCE
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.
ESSENTIAL FUNCTIONS
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.
I. Manager over Study Start-Up Navigators, Study Feasibility Project Managers and Study Oversight Project Managers who perform the following activities:
Trial Navigation: 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.
Trial Feasibility Analyses: SFPMs work closely 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.
Study Oversight Services: 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.
II. Study Oversight Project Management
Study Oversight Manager helps to set up, monitor and manages the overall progress of trials.<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>
III. Performs other related duties incidental to the work described herein.
SKILLS/QUALIFICATIONS
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.
Our Commitment to You:
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:
Compensation<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>
Benefits and more<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> 
About Advocate Health
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.
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

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $70,000 - $80,000</li>
</ul><div>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</div> 
<div></div>

Position Summary

Reporting directly to the Associate Director of Regulatory Science (the &quot;Associate Director&quot;) of the Clinical Trials Office (the &quot;CTO&quot;) of Columbia University's Vagelos College of Physicians &amp; Surgeons (&quot;P&amp;S&quot;) at Columbia University Irving Medical Center (&quot;CUIMC&quot;), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials.

The CTO, which is operated jointly with the New York-Presbyterian Hospital (&quot;NYPH&quot;) assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research.

Responsibilities

The Regulatory Science Specialist is responsible for the following:
<ul>
<li>Collaborates with the Associate Director, the Executive Director of the CTO (the &quot;Director&quot;), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals.</li>
<li>Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission.</li>
<li>Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials.</li>
<li>Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request.</li>
<li>Provides guidance regarding regulatory and institutional requirements to investigators and research personnel</li>
<li>Provides assistance and support in creating and maintaining www.ClinicalTrials.gov records in compliance with applicable regulations and policies.</li>
<li>Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials.</li>
<li>Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs.</li>
<li>Provides support of RecruitMe Platform for the CUIMC research community including:</li>
<li>Coordinating with investigators and research teams in RecruitMe entry.</li>
<li>Developing training and process improvement projects, and other project management duties with RecruitMe.</li>
<li>Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites.</li>
<li>Fulfilling reporting requirements for management, including metrics from Google Analytics data.</li>
<li>Monitoring external communications for social media websites.</li>
<li>Liaising with RecruitMe contacts, information technology (&quot;IT&quot;) groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites.</li>
Represents the Manager and Director in his/her absence and all other duties as assigned. 
<li>
</li>
</ul>Minimum Qualifications
<ul>
<li>Bachelor's degree</li>
<li>At least 4 years of experience in conducting clinical research</li>
</ul>
Preferred Qualifications
<ul>
<li>In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:</li>
<li>Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs</li>
<li>Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research</li>
<li>Demonstrable ability to collaborate with partners in research, investigators and coordinators</li>
<li>Excellent verbal and written communication skills</li>
<li>Excellent interpersonal and presentation skills</li>
<li>Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office</li>
Ability to manage/handle multiple tasks, teams, and teamwork simultaneously. 
<li>
</li>
</ul>Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Regulatory Science Specialist

Syneos Health

<div>Description
Sr CRA II - FSP - Turkey - Homebased
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health<ul><li>
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>
We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records 
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.</li><li>
Understands project scope, budgets, and timelines for own and others&rsquo; activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.</li><li>
For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include: 
Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs 
Chart abstraction activities and data collection 
As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff 
The SMA II may be requested to train junior staff 
Identify and communicate out of scope activities to Lead CRA/Project Manager 
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 
Identify operational efficiencies and process improvements 
Develop study and country level informed consent forms 
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared 
Participate in bid defense meetings 
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy. 
Participate in Case Report Form design and edit check development.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div>

Sr CRA II - FSP - Turkey - Homebased

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