clinical research coordinator ii

University of Alabama, Birmingham

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), Med - Cardiovascular Disease, is seeking a Clinical Research Coordinator II.</p><p><b>
General Responsibilities</b></p><p></p><ul><li><p><br>
To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.</p></li><li><p>
To support screening and participant eligibility determination, working with more senior team members to ensure compliance.</p></li><li><p>
To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).</p></li><li><p>
To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.</p></li></ul><p><b>
Key Duties &amp; Responsibilities</b></p><p>
We are seeking a Clinical Research Coordinator II to perform some of or all of the following duties and responsibilities, depending on the candidate's experience level:</p><ul><li><p>
Recruits, screens, consents, and enrolls participants.</p></li><li><p>
Implements study participant recruiting and screening protocols.</p></li><li><p>
Meets recruitment and enrollment goals.</p></li><li><p>
Manages all aspects of assigned clinical studies, including education.</p></li><li><p>
Collects, analyzes, and enters data for clinical trials and ensures quality control.</p></li><li><p>
Completes enrollment logs, informed consent logs, and all other data forms with high accuracy and attention to detail.</p></li><li><p>
Assists in the coordination of lab work.</p></li><li><p>
Prepares for study monitoring visits.</p></li><li><p>
Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, and IRB-, Good Clinical Practice-, and HIPAA regulations are followed.</p></li><li><p>
Uses REDCap and SPSS databases to enter and summarize study data.</p></li><li><p>
Monitors compliance of study procedures with federal, state, and university regulations.</p></li><li><p>
Performs general clerical duties (faxing, scanning, routing messages, coordinating the purchase of study supplies/materials).</p></li><li><p>
Works with minimal supervision, plans, organizes, and coordinates multiple work assignments, and establishes and maintains effective working relationships with others.</p></li><li><p>
Effectively and professionally communicates sensitive information and maintains confidentiality.</p></li><li><p>
Assist with regulatory submissions and duties.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p></p><p><b><br>
Annual Salary Range</b>: $50,050 - $81,330</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.</p><p><b>
Preferences</b></p><ul><li><p>
Previous clinical research experience, particularly in cardiovascular studies.</p></li><li><p>
Familiarity with REDCap and SPSS databases for data entry and analysis.</p></li><li><p>
Experience with Good Clinical Practice (GCP) guidelines and regulatory compliance.</p></li><li><p>
Knowledge of IRB processes and HIPAA regulations.</p></li><li><p>
Strong attention to detail for accurate data collection and documentation.</p></li><li><p>
Excellent interpersonal and communication skills for patient interaction.</p></li><li><p>
Ability to work independently with minimal supervision while managing multiple studies.</p></li></ul><p><br>
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.</p><div><br>
</div></div><div><b>
Primary Location</b><b>:</b> University</div><div><b>
Job Category</b><b>:</b> Clinical Research</div><div><b>
Organization</b><b>:</b> 311401000 Med - Cardiovascular Disease</div><div><b>
Employee Status</b><b>:</b> Regular</div><div><b>
Shift</b><b>:</b> Day/1st Shift</div><div><b>
Work Arrangement (final schedule to be determined by the department/hiring manager)</b><b>:</b> Onsite</div></div></div></div></div><div></div>

CLINICAL RESEARCH COORDINATOR II

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

Clinical Research Coordinator III

CenExel Clinical Research

<p></p><div><p><b>About Us:
</b></p><p>Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.</p><br>
<p></p>
<p>
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.</p><br>
<p></p>
<p><b>
Job Summary:
</b></p><p>Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.</p><br>
<p></p>
<p><b>
Compensation: </b>$35-$41/h depending on education, experience, and skillset.</p><br>
<p></p>
<p><b>
Essential Responsibilities and Duties:</b></p>
<ul>
<li>Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.</li>
<li>Organizes research information for clinical trials.</li>
<li>Observes subjects and assists with data analysis and reporting.</li>
<li>Oversees study protocol scheduling and collection of data.</li>
<li>Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.</li>
<li>Manages, monitors, and reports research data to maintain quality and compliance.</li>
<li>Performs administrative and regulatory duties related to the study as appropriate.</li>
<li>Participates in other protocol development activities.</li>
<li>Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.</li>
<li>Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)</li>
<li>Educates potential participants and caregivers on protocol specific details and expectations.</li>
<li>Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).</li>
<li>Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.</li>
<li>Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.</li>
<li>Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul><br>
<p></p>
<p><b>
Education/Experience/Skills:</b></p>
<ul>
<li>Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position.</li>
<li>Bachelor's degree, preferred.</li>
<li>CCRC certification preferred.</li>
<li>5 years of experience in the medical field or Masters Degree, preferred.</li>
<li>Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.</li>
<li>Strong leadership and mentorship skills.</li>
<li>Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.</li>
<li>Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.</li>
<li>Works independently as well as functioning as part of a team.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul><br>
<p></p>
<p><b>
Working Conditions
</b></p><div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Shift work, depending on location.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>Overnight travel may be required for training and/or investigative meetings.</li></ul></div><br>
<p></p>
<p>
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.</p><p></p><p>
Equal Opportunity Employer<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</p></div>

Clinical Research Coordinator Sr.

The IMA Group

<div><div><h2 class="jobSectionHeader"><b>Clinical Research Coordinator &ndash; Austin, TX</b></h2><div>
(<b>Clinical Research - Research Coordinator - Research Assistant - Clinical Research Associate</b>)</div><div>
</div><div>
Join <b>IMA Clinical Research</b> as a <b>Clinical Research Coordinator</b> and help drive innovative <b>clinical research</b> studies that improve patient outcomes. This role is ideal for candidates experienced in <b>Research</b>, <b>Research Coordination</b>, <b>Clinical Research Associate</b> work, or <b>Research Assistant</b> responsibilities.</div><h3 class="jobSectionHeader"><b>
What You&rsquo;ll Do</b></h3></div><ul><li>
Support and coordinate clinical research trials from start to finish</li><li>
Guide patients through study visits and research procedures</li><li>
Work closely with investigators, sponsors, labs, and monitors</li><li>
Complete blood draws and clinical tasks</li><li>
Maintain accurate research documentation (ALCOA)</li></ul><div><h3 class="jobSectionHeader"><b>
What We&rsquo;re Looking For</b></h3></div><ul><li>
At least 2 years of <b>clinical research</b> experience (required)</li><li>
Phlebotomy experience (required)</li><li>
Bachelor&rsquo;s degree; Master&rsquo;s or CCRC a plus</li><li>
Strong organization skills and ability to manage multiple research studies</li></ul><div><h3 class="jobSectionHeader"><b>
What We Offer</b></h3></div><ul><li>
Fast-paced clinical research environment</li><li>
No on-call work</li><li>
Tuition support &amp; student loan assistance</li><li>
Medical, dental, vision, 401(k) match, PTO, holidays</li></ul><div><div>
</div><div>
Join our growing <b>Clinical Research</b> team and build your career as a <b>Clinical Research Coordinator</b>, <b>Research Coordinator</b>, <b>Clinical Research Associate</b>, or <b>Research Assistant</b>.</div></div><div>
</div><div></div><div><b><i>The IMA Group is an Affirmative Action/Equal Opportunity Employer</i></b>
</div><div></div><div>Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
</div><div></div><div>#LI-EG1 #LI-ONSITE</div></div>

Clinical Research Coordinator - Growing Clinical Research Team - Austin, TX

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), DOM Research Unit [RET], is seeking a Clinical Research Regulatory Coordinator I. This position will support the Clinical Research Support Enterprise (CReSt). This position requires on-site workdays and does not offer remote work options.</p><p><b>
General Responsibilities</b></p><p></p><ul><li><p><br>
To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.</p></li><li><p>
To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.</p></li><li><p>
To assist with initial drafts of informed consent documents.</p></li><li><p>
To prepare regulatory binders and associated documentation.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p><b>
Hourly Range</b>: $18.85 - $30.65</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
High School diploma or GED required.</p><p><br>
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.</p><div><br>
</div></div><div><b>
Primary Location</b><b>:</b> University</div><div><b>
Job Category</b><b>:</b> Clinical Research</div><div><b>
Organization</b><b>:</b> 311400030 DOM Research Unit [RET]</div><div><b>
Employee Status</b><b>:</b> Regular</div><div><b>
Shift</b><b>:</b> Day/1st Shift</div><div><b>
Work Arrangement (final schedule to be determined by the department/hiring manager)</b><b>:</b> Onsite</div></div></div></div></div><div></div>

CLINICAL RESEARCH REGULATORY COORDINATOR I

University of Pennsylvania Health System

<div><p><b>Description</b>
</p>Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.<br>
<br>
Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?<p><b><br>
Entity: CCA-Penn Primary Care and Penn Specialty Practices</b></p>
<p><b>Department: Valley Forge Floor 3</b></p>
<p><b>Location: Penn Medicine Valley Forge- 1001 Chesterbrook Blvd</b></p>
<p><b>Hours: Full-Time
</b></p><p>Summary:</p>
<ul><li>The Ambulatory Nurse II Colleague is an RN that practices as a full partner on the health care team and consistently demonstrates safe practice within the organizational professional practice model.</li><li>
The Ambulatory Nurse II Colleague possesses the knowledge, skills and the attitude to effectively meet standards for competent professional nursing practice as specified in the Ambulatory Nurse II position description addendum. The Ambulatory Nurse II Colleague exhibits UPHS organizational behavioral competencies which reflect its mission and are embedded in the professional practice competency domains.</li><li>
The Ambulatory Nurse II Colleague independently provides patient care through the application of the nursing process and accepts accountability for the nursing care of assigned patients. Assigned patients may range in age from infancy to the elderly. The Ambulatory Nurse II Colleague demonstrates within the competency domains of Continuous Quality Improvement, Evidence Based Practice and Research, Leadership, Person and Family Centered Care, Professionalism, Safety, Technology/Informatics, and Teamwork (Definitions listed below).</li><li>
The Ambulatory Nurse II Colleague works closely with the interprofessional health care team to facilitate the coordination of care across the continuum. The nurse focuses on expanding the knowledge and skills necessary to provide individualized care based on physical, psychosocial, cultural, educational, safety, and age appropriate considerations of assigned patients.</li></ul>
<p>Responsibilities:</p>
<ul><li>Evidence Based Practice and Research: The nurse evaluates and integrates best current evidence with clinical expertise and patient and family preferences and values for the delivery of optimal health care and system effectiveness.</li><li>
Safety: The nurse minimizes risk of harm to patients, families, providers and self through system effectiveness and individual performance.</li><li>
Professionalism: The nurse demonstrates a commitment to the nursing profession through lifelong learning, adherence to ANA&rsquo;s Code of Ethics for Nurses, participation in a professional organization and advancing community outreach.</li></ul>
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.<br>
<br>
Live Your Life's Work<p></p><p>
We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.</p></div>

Ambulatory Nurse II

ICON plc

<div>Site Specialist II, Study Start Up<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Site Specialist II (Study Start Up Associate II) to join our diverse and dynamic team. As a Site Specialist II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.</div><div></div><div>
What you will be doing</div><ul><li><div>
Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.</div></li></ul><ul><li><div>
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.</div></li></ul><ul><li><div>
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence</div></li></ul><ul><li><div>
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.</div></li></ul><ul><li><div>
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.</div></li></ul><div></div><div>
Your profile</div><ul><li><div>
Bachelor's degree in life sciences or a related field.</div></li></ul><ul><li><div>
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.</div></li></ul><ul><li><div>
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.</div></li></ul><ul><li><div>
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.</div></li></ul><ul><li><div>
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.</div></li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Site Specialist II, Study Start Up

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