clinical research manager

Stanford University

<div><p>The Tass Lab at Stanford University is seeking a Clinical Research Manager to provide leadership and operational oversight for our pioneering research in Parkinson&rsquo;s disease. This key role offers a unique opportunity to partner directly with faculty to transform groundbreaking research visions into clinical reality. You will serve as the strategic backbone of our studies&mdash;empowering clinical staff, navigating regulatory excellence, and ensuring our fiscal and operational management is as world-class as the science itself.</p><p><b><br>
Duties include*:</b></p><ul><li>
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.</li><li>
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.</li><li>
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.</li><li>
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.</li><li>
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.</li><li>
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.</li><li>
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.</li><li>
Make recommendations for a variety of options within a trial; track physician compliance.</li><li>
Assist with analysis of data and preparation of manuscripts and scientific presentations.</li><li><i>- Other duties may also be assigned</i></li></ul><br>
<p></p>
<div><p><b>EDUCATION &amp; EXPERIENCE (REQUIRED):</b></p><p>
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred</p><p><b>
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):</b></p><ul><li>
Excellent interpersonal skills.</li><li>
Proficiency in Microsoft Office and database applications.</li><li>
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.</li><li>
Knowledge of medical terminology.</li><li>
Demonstrated managerial experience.</li></ul><p><b>
CERTIFICATIONS &amp; LICENSES:</b></p><p>
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.</p><p><b><br>
PHYSICAL REQUIREMENTS*:</b></p><ul><li>
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.</li><li>
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.</li><li>
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.</li><li><i>- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.</i></li></ul><p><b><br>
WORKING CONDITIONS:</b></p><ul><li>
Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.</li><li>
May require extended or unusual work hours based on research requirements and business needs.</li></ul><p><b><br>
WORK STANDARDS:</b></p><ul><li>
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.</li><li>
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.</li><li>
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.</li></ul><p><br>
The expected pay range for this position is $124,521 to $153,615 per annum.</p><p>
Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.</p><p>
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.</p><p>
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.<br>
<br>
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.</p><p>
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.</p></div></div>

Clinical Research Manager

Arizona Arthritis and Rheumatology

<div>Description:
<p>
Arizona Arthritis &amp; Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States. The practice has over 60 providers, 15 sites and over 350 employees providing assessment and treatments for our rheumatology patients. Our providers work together to keep patients healthy, and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.</p><p>
We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.</p><p>
Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.</p><p>
We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Coordinator to join our team.</p><p>
The Regional Research Manager reports to the Director of Clinical Research and is responsible for the clinical research staff &amp; daily operations at each assigned medical clinic (research site).</p><p>
RESPONSIBILITIES</p><ul><li>
Travel daily to research sites to provide support and complete job responsibilities listed below</li><li>
First line manager (direct, supervise, and evaluate) to research coordinators and assistants</li><li>
Conduct training and mentorship of new clinical research staff, ensuring their success</li><li>
Assign tasks and studies to ensure workloads are balanced among recruitment staff</li><li>
Utilize Clinical Trial Management System weekly to ensure productivity goals are met</li><li>
Monitor electronic source data capture system reports to ensure data and query goals are met</li><li>
Meet with employees monthly to review metrics and conduct weekly huddles with the team</li><li>
Perform HR responsibilities including interviews, reviews, reprimands, and terminations</li><li>
Manage operations at the clinical sites and facilitate all medical staff&rsquo;s participation in research</li><li>
Implement Clinical Trial Agreements &amp; Budgets and ensure model fiscal operations</li><li>
Assist with qualifying and onboarding vendors and staff for clinical services as required per study</li><li>
Approve and order supplies and equipment as needed from sponsors and vendors</li><li>
Ensure clinical research staff have the skills and resources necessary for success</li><li>
Ensure clinical sites have the medical equipment and resources necessary for success</li><li>
Ensure clinical sites are engaging in recruitment activities and meeting patient enrollment goals</li><li>
Facilitate operational changes using professional and positive motivation</li><li>
Ensure compliance with research protocols, handbook policies, standard operating procedures, ICH-GCP Standards, FDA regulations, medical laws and implement solutions for compliance</li><li>
Perform quality assurance and complete corrective action and prevention assessment plans</li><li>
Conduct Pre-Study Visits and Site Initiation Visits for new clinical trials</li><li>
Serve as an escalation point all clinical trials and first point of contact for site staff members</li><li>
Provide ongoing support, needs assessment, and issue resolution to clinical sites and staff on an ongoing basis, and escalate to Director of Clinical Research when needed</li><li>
Communicate with physicians, vendors, sponsors and CROs to address and resolve issues</li><li>
Collaborate with fellow Regional Research Managers to ensure a consistent and coordinated department and management style across all sites nationally</li><li>
Meet with administrative staff regularly to ensure all research operations are running smoothly</li><li>
Perform duties for coordinators and managers when there is a lapse in coverage</li><li>
Participate in continuing education to remain a subject matter expert on all research protocols, medical indications, company policies, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal medical laws</li></ul><p>
Learn more about AARA on our website at http://azarthritis.com</p>
Requirements:
<p>
QUALIFICATIONS</p><ul><li>
Bachelor&rsquo;s Degree, or equivalent</li><li>
2 years&rsquo; experience as clinical research coordinator</li><li>
Subject Matter expert in clinical research and relevant clinical indications</li><li>
Understands specific state and federal regulations governing medicine and privacy</li><li>
Possess strong leadership &amp; organizational skills</li><li>
Excellent verbal and written communication skills</li><li>
Willing and able to travel to all regional offices daily</li><li>
Management experience and/or formal training preferred but not required</li><li>
Clinical Research Certification (CRCC/CCRP) preferred but not required</li></ul></div>

Clinical Research Regional Manager

The General Hospital Corporation

<div>Site: The General Hospital Corporation<p></p><p><br>
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.</p><p></p><p><b><br>
Job Summary</b></p>
Summary<br>
Responsible for managing a clinical study involving multiple sites around the world. Leading the efforts on selecting the sites, testing the sites capabilities to ensure long-term compliance, engaging in contractual agreements with the sites, working together with the department to manage the execution of the site agreements, training the staff at each site with respect to the study protocol and data upload to the web-based data collection system. Responsible for the generation of standard operating procedures; works directly with investigators, clinicians, software developers and other lab personnel.
<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Engages potential sites and tests their capabilities for long-term compliance.
</li><li>Trains the site coordinators at each clinical site.
</li><li>Monitors the site coordinators at each clinical site.
</li><li>Trains newly hired technical staff to work on this project.
</li><li>Responsible for the generation and maintenance of standard operating procedures.
</li><li>Responsible for communicating project progress with the sponsor.
</li><li>Responsible for troubleshooting problems related to access the web based registry.
</li><li>Prepares reports and presents progress at research staff meetings.</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required<br>
<br>
Can this role accept experience in lieu of a degree?<br>
No<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Research Related Experience 3-5 years required<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Excellent critical thinking skills and ability to work independently are essential.</li><li>Must be self-motivated and able to work independently.</li><li>Good verbal and written communication skills.</li><li>Proficiency in Word, Power point, Excel.</li><li>Ability to make independent effective decisions.</li><li>Strong organizational skills.</li><li>Demonstrated analytical skills to problem solve effectively.</li></ul></div><p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Onsite<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
55 Fruit Street<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$78,936.00 - $126,401.60/Annual<p></p><p><b><br>
Grade</b></p>
8<br>
<p></p>
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.<p></p><div><div><div><div><div><div><div><p><b><br>
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.<p></p><h2 class="jobSectionHeader"><b><br>
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>

Clinical Research Program Manager

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, VA, SC, TX 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>Manager, Clinical Operations </b>is responsible for leading the operational performance of the clinical research staff. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures.</div><h3 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h3><div><b><br>
Essential Job Duties:</b></div><ul>
<li>Overall team management and leadership support with a focus on driving study performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance.</li>
<li>Collaborating with other departments (Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality) to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors.</li>
<li>Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency).</li>
<li>Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget).</li>
<li>Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study.</li>
<li>Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures.</li>
<li>Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level.</li>
<li>Overseeing people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and employment meetings.</li>
<li>Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations.</li>
<li>Collaborating with investigators to ensure patient safety and meeting client goals and timelines.</li>
<li>Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.</li>
<li>Participating and presenting in management or site meetings.</li>
<li>Perform all other duties as required or assigned.</li></ul><br>
<h3 class="jobSectionHeader"><b>
Skills, Knowledge and Expertise</b></h3><div><br>
<b>
Minimum Qualifications:</b><br>
Bachelor&rsquo;s degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience, is required. 2+ years&rsquo; experience as a clinical research coordinator (CRC). 1+ years of management experience in clinical research is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.<br>
</div><div><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>Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines.</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 Operations Manager - Bilingual required (English/Spanish)

Children's Hospital of Philadelphia

<div><p>SHIFT:</p>
Day (United States of America)<p></p><p><b>
Seeking Breakthrough Makers</b><br>
<br>
Children&rsquo;s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.<br>
<br>
At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care&mdash;and your career.<br>
<br>
CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.<br>
<br>
<b>A Brief Overview</b></p><p>
The Very Early Onset (VEO) Inflammatory Bowel Disease Research Program Manager will join a highly collaborative and high performing team dedicated to uncovering the genetic and immunologic drivers of VEO-IBD and advancing targeted therapeutic approaches.</p><p><br>
</p><p>This management role entails providing clinical organizational support for the research in the VEO Program, directed by Judith Kelsen, MD. Our multidisciplinary translational program includes experts in immunology, genetics, bioinformatics, pathology and basic science biology who are highly collaborative and innovative using cutting edge technologies to develop an individualized and targeted therapies to help improve our patients&rsquo; quality of life.</p><p>
We are seeking a full-time clinical research program manager who works closely with the clinical care team as well as the clinical and laboratory research teams. This is a unique career opportunity to be part of a large prospective translational research program that includes a large patient registry and biorepository and collaborations that span CHOP, the University of Pennsylvania and many national and international collaborators. Responsibilities include, but are not limited to, organizing the recruitment of research participants, interfacing with clinical care and lab staff to schedule research visits, ensuring adherence to study protocols, preparing and submitting regulatory documentation to the Institutional Review Board, developing and maintaining accurate clinical study databases, collaborating with laboratory teams, and supervising clinical research coordinators. The ideal candidate is an exceptional communicator with strong organizational and time‑management skills, advanced medical knowledge, and prior experience in a clinical setting.</p><p><b><br>
What you will do</b></p><ul><li>
Supervision, training, support, and management of staff (direct and/or indirect) to ensure compliance with study protocol, NIH and FDA policies.</li><li>
Work collaboratively and effectively with the individual study management teams, various core groups at CHOP&rsquo;s Research Institute and other participating institutions.</li><li>
As part of Management Team, develop, review, and update program policies and procedures as needed.</li><li>
Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s).</li><li>
Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed.</li><li>
Track regulatory compliance of CHOP and other sites.</li><li>
Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.</li><li>
Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.</li><li>
Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program.</li><li>
Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research.</li><li>
Responsible for Regulatory compliance for clinical research program.</li><li>
Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle.</li><li>
Additional responsibilities may include</li><li>
Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports.</li><li>
Serve as the primary contact for trial for internal and external participants.</li></ul><p><b>
Education Qualifications</b></p><ul><li>
Bachelor's Degree Required</li><li>
Master's Degree in a related field Preferred</li></ul><p><b>
Experience Qualifications</b></p><ul><li>
At least five (5) years of relevant &amp; complex research experience Required</li><li>
At least seven (7) years of relevant &amp; complex research experience Preferred</li><li>
At least one (1) year of leadership, management or supervisory experience Required</li><li>
At least three (3) years of leadership, management or supervisory experience in a clinical research or academic environment Preferred</li><li>
At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management Preferred</li></ul><p><b>
Skills and Abilities</b></p><ul><li>
Excellent verbal and written communications skills</li><li>
Excellent interpersonal skills</li><li>
Excellent customer service skills</li><li>
Excellent time management skills</li><li>
Strong critical thinking / problem-solving skills</li><li>
Strong project management skills</li><li>
Strong organizational skills</li><li>
Strong analytical skills</li><li>
Solid leadership skills</li><li>
Ability to maintain confidentiality and professionalism</li><li>
Ability to work independently with minimal supervision</li><li>
Ability to convey complex or technical information in an easy-to-understand manner</li><li>
Ability to collaborate with stakeholders at all levels</li><li>
Ability to be flexible and adaptable to change</li></ul><p><b><br>
To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. </b><b>Learn more.</b><br>
<br>
<b>EEO / VEVRAA Federal Contractor</b><b> | </b><b>Tobacco Statement
</b></p><p></p><p><b>SALARY RANGE:</b></p><p></p>
$74,250.00 - $94,660.00 Annually<p></p><p>
Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.</p><p></p><p>
-</p>
This job is eligible for an incentive program.<p></p><p>
At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.</p></div>

Clinical Research Program Manager I - Very Early Onset (VEO) Inflammatory Bowel Disease

University of Alabama, Birmingham

<div></div><div><div><div><div><div><b>Description</b><div></div><p>
The University of Alabama at Birmingham (UAB), Clinical Research Support Enterprise, is seeking a Manager-Clinical Research Nursing.</p><p><b>
General Responsibilities</b></p><ul><li><p>
To oversee staff in conducting all study activities including more complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).</p></li><li><p>
To assist with the management of the life cycle of the clinical trial as needed from study start-up through trial maintenance to study closure.</p></li><li><p>
To oversee and/or manage multiple clinical research protocols and the associated personnel.</p></li><li><p>
To serve as a resource person or act as a subject matter expert (SME) within area of clinical expertise.</p></li></ul><p><b>
Key Duties &amp; Responsibilities</b></p><ul><li><p>
Provides strategic and operational leadership for the CReSt study startup and clinical research systems infrastructure.</p></li><li><p>
Guides and directs startup workflows to ensure the timely, accurate, and efficient execution of feasibility coordination, protocol calendar development, billing plan alignment, OnCore configuration, and EPIC research integration.</p></li><li><p>
Establishes and monitors startup performance indicators, identifies process inefficiencies, and implements structured workflow improvements to enhance activation timelines and operational performance.</p></li><li><p>
Serves as a clinical and operational subject matter expert (SME) across drug, device, behavioral, and investigator-initiated trials.</p></li><li><p>
Leads process improvement initiatives to strengthen research infrastructure, promote financial stewardship, and ensure compliance with IRB, FDA, and Good Clinical Practice (GCP) standards.</p></li><li><p>
Performs other duties as assigned.</p></li></ul><p><b>
Annual Salary Range</b>: $85,600 - $139,100</p><div><br>
</div></div><div><b>
Qualifications</b><div></div><p>
Bachelor's degree in a related field and eight (8) years of related experience required. <b>Work experience may NOT substitute for education requirement.</b> Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing 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> 310009510 Clinical Research Support Enterprise</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> Hybrid Eligible</div></div></div></div></div><div></div>

MANAGER-CLINICAL RESEARCH NURSING

University of California - San Francisco

<p></p><div><div><div><div>Under the supervision of the Clinical Research Manager, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed. Responsibilities include communicating with the Clinical Trial manager to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI. The CRC will support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies).
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The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.<br>
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The duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator&rsquo;s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.<br>
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The Department of Urology in the School of Medicine educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, San Francisco General Hospital (SFGH), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.<br>
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<b>Note</b>: The work schedule will be Wednesday (8 hours); remote Tuesday 8hrs via zoom Bayne TH clinic, remaining days, 8 hours a week but can be remote with occasional in-person as needed.<p><br>
The final salary and offer components are subject to additional approvals based on UC policy.</p><p>
Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.</p><p>
The salary range for this position is $34.32 - $55.19 (Hourly Rate).</p><p>
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html</p></div>
</div><div><p><b>Department Description</b></p>
<div>The Department of Urology in the School of Medicine (SOM) educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, Zuckerberg San Francisco General (ZSFG), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children&rsquo;s Hospital Oakland.</div>
</div><div><p><b>Required Qualifications</b></p>
<div><ul><li>HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.</li><li>
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.</li><li>
Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.</li><li>
Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments.
</li><li>Outstanding communication skills</li><li>
Ability to learn new tasks quickly and apply good judgement in unexpected situation</li></ul></div>
</div><div><p><b>Preferred Qualifications</b></p>
<div><ul><li>Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.</li><li>
Knowledge/experience with research regulatory process</li><li>
Knowledge/experience with in RedCAP database, Oncore</li><li>
Knowledge/experience in submitting protocol to Institutional Review Board (IRB or CHR)</li><li>
Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.</li><li>
Experience with EPIC medical record system or other electronic medical records.</li><li>
Previous UC experience</li><li>
4yrs college graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.</li><li>
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.</li><li>
Experience applying the following regulations and guidelines:<ul><li>
Good Clinical Practice Guidelines</li><li>
Health Information and Accountability Act (HIPAA)</li><li>
The Protection of Human Research Subjects</li><li>
CHR regulations for recruitment and consent of research subjects</li><li>
Effective Cash Handling Procedures</li><li>
Environmental Health and Safety Training</li><li>
Fire Safety Training</li></ul></li></ul></div>
</div><div><p><b>About UCSF</b></p>
<div>The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world&rsquo;s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.</div>
</div><div><p><b>Pride Values</b></p>
<div>UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence &ndash; also known as our PRIDE values.
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In addition to our PRIDE values, UCSF is committed to equity &ndash; both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
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Join us to find a rewarding career contributing to improving healthcare worldwide.</div>
</div><div><p><b>Equal Employment Opportunity</b></p>
<div>The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.</div>
</div><div><p><b>Organization</b></p>
<div>Campus</div>
</div><div><p><b>Job Code and Payroll Title</b></p>
<div>009335 CLIN RSCH CRD
</div></div><div><p><b>Job Category</b></p>
<div>Research and Scientific</div>
</div><div><p><b>Bargaining Unit</b></p>
<div>University Professional Technical Employees &ndash; Research Support Professionals Unit (UPTE-RX)
</div></div><div><p><b>Employee Class</b></p>
<div>Career</div>
</div><div><p><b>Percentage</b></p>
<div>60%</div>
</div><div><p><b>Location</b></p>
<div>Oakland, CA, San Francisco, CA</div>
</div><div><p><b>Campus</b></p>
<div>Benioff Children's Hospital, Mission Bay (SF), Parnassus Heights (SF)</div>
</div><div><p><b>Work Style</b></p>
<div>Fully On-Site</div>
</div><div><p><b>Shift</b></p>
<div>Days</div>
</div><div><p><b>Shift Length</b></p>
<div>6 Hours
</div></div><div><p><b>Additional Shift Details</b></p>
<div>Monday - Friday</div></div></div></div><div></div>

Part-Time Clinical Research Coordinator

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