clinical project coordinator

ProPharma

<div>
 For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.
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 **In Office position reporting to either Gaithersburg, MD OR Conshohocken, PA offices**
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 Reporting to one of the VPs, Clinical Development, the Clinical Administrative &amp; Project Coordinator will provide essential support to senior clinicians, including targeted assistance on selected clinical trials they lead within our biotech company. This role will be critical in enabling senior clinicians to focus on their highest-impact activities. To achieve this, the role will focus on ensuring smooth day-to-day functioning of senior physicians&rsquo; schedules; facilitating communications inter- and intra-departmentally; and supporting administrative, operational and business processes, including those related to selected clinical trials. The ideal candidate will be a detail-oriented, highly motivated self-starter, eager to contribute in a dynamic, fast-paced biotech environment. They will have exceptional problem-solving and critical analysis skills, strong interpersonal skills, excellent written, oral and graphic communication skills, ability to leverage technology and artificial intelligence, and an expert attention to detail. Further, they will excel at managing multiple priorities concurrently and will be comfortable collaborating across a diverse range of stakeholders.
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  Executive Support
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   Provide high-quality administrative support to multiple senior clinicians, including drafting correspondence, preparing presentations, and coordinating communications across departments
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   Collaborate closely with the Chief of Staff, Executive Administrator, and Clinical Development Leadership Team to facilitate efficient daily operations
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   Assist with maintaining documentation, policies, and procedures within Clinical Development
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   Act as a point of contact between Clinical Development and cross-functional teams, managing information flow with clarity and discretion
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   Ensure confidentiality and professionalism when handling sensitive information
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  Calendar and Time Management
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   Efficiently and thoughtfully manage the complex calendars of multiple senior clinicians, with a keen eye to prioritization and stakeholder management
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   Screen requests for, and coordinate meetings, calls, interviews and small and large events for the senior clinicians
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   Ensure time is optimized and aligned with clinical trial milestones and business objectives
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   Handle last-minute changes and conflicts with tact and professionalism
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  </li>
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  Meeting Coordination &amp; Advising
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   Prepare agendas for key meetings within Clinical Development, take notes and identify action items and follow-up over the short and long term in support of the senior clinicians
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   Ensure senior-level Clinical Development meetings are effective and efficient by ensuring all stakeholders are prepped and agendas and pre-reads are provided in advance, and action items are tracked after each meeting
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   Ensure effective and timely information flow between meetings and stakeholders, seaming together different workstreams and conversations
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  International Travel Planning and Investigator Outreach
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   In support of senior clinicians involved in investigator engagements and scientific congress attendance, organize and manage detailed, complex international travel itineraries including flights, accommodations, visas, ground transportation, and expense reports
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   Provide professional support for outreach to clinical trial sites and investigators, ensuring communication is timely and accurate
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   Anticipate the needs of senior clinicians while ensuring compliance with company travel policies and budget constraints
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  Project &amp; Data Support
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   Support Clinical Development in tracking project timelines, milestones, and deliverables, generating and sharing routine updates as needed
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   Assist on special projects (e.g., ad hoc data analyses) and process improvements from senior-level Clinical Development meetings to facilitate departmental and corporate objectives
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   Apply project management principles to ensure timely delivery of projects and process improvements (e.g., track timelines, deliverables, and accountabilities)
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   Assist with preparation and formatting of reports, updates, and presentations for internal stakeholders and external collaborators
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   Leverage technology and software tools (Microsoft Office, CRM systems, project trackers, AIenabled tools) to streamline workflows and enhance team productivity
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  Required Experience &amp; Knowledge
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   Bachelor's degree
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   At least 2-3 years of experience in a project coordinator, analyst or administrative support role
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   Strong organizational skills with the ability to manage multiple tasks and priorities.
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   Excellent written, verbal and graphic communication skills.
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   Professional presence and expert interpersonal skills to build strong relationships with executive team members, colleagues and junior staff
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   Experience with calendar management, travel coordination, and meeting planning.
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   Exceptional computer skills, including advanced proficiency with Microsoft Office Suite (Excel, PowerPoint, Word, Forms) and calendar management software (Outlook, Google Calendar, etc.)
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   Strong problem-solving skills and the ability to work independently in a fast-paced, dynamic environment.
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   Enthusiastic and open attitude towards continuous professional development
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  Preferred Experience &amp; Knowledge
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   Bachelor&rsquo;s Degree in Business, Life Sciences, or a related field.
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   Prior experience in clinical research and/or biotechnology, pharmaceutical or healthcare industries
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   Awareness of clinical trial processes and regulatory requirements
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   Experience with travel and expenses management
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   Familiarity with project management, customer relationship management and AI tools
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 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
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 All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
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 ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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Clinical Administrative & Project Coordinator

Intermountain Health

<div><p><b>Job Description:</b></p>
This position provides research project support to requesting department to ensure timelines and effectiveness in<br>
<br>
activation and completion of needed research projects. Responsible for routine to moderately complex project<br>
<br>
coordination / project management as well as communication and documentation as required by the research<br>
<br>
departments.<p><b>
Work Schedule</b></p><ul><li><b>
Hybrid role &ndash; </b>Position requires on-site presence at times during the week, with flexible scheduling</li><li><b>
Core business hours: </b>Monday&ndash;Friday, 8:00 a.m. &ndash; 5:00 p.m.</li></ul><p></p><p><b>
Essential Functions
</b></p><ul><li><b>Research Support and Administration:</b> Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources.</li><li><b>
Project Planning &amp; Execution:</b> Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed.</li><li><b>
Budget &amp; Scope Management:</b> Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing.</li><li><b>
Study Requirements &amp; Compliance:</b> Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements.</li><li><b>
Quality Assurance &amp; Documentation:</b> Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices.</li><li><b>
Study Lifecycle Management:</b> Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator.</li><li><b>
Medicare Coverage Analysis:</b> Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review.</li><li><b>
Auditing &amp; Risk Management:</b> Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations.</li></ul><p></p><p><b>
Skills</b></p><ul><li>
Budgeting</li><li>
Financial negotiation</li><li>
Attention to detail</li><li>
Multitasking</li><li>
Clear written and verbal communication</li><li>
Task Prioritization</li><li>
Process Improvement</li><li>
Critical thinking</li><li>
Collaboration</li><li>
Research</li></ul><p></p><p><b>
Minimum Qualifications
</b></p><ul><li>Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.</li><li>
Demonstrated experience working in a collaborative team environment.</li><li>
Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.</li><li>
Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required.</li><li>
Clinical licensure, experience or certification may be required due to grant funding requirements. &middot; Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.</li><li>
Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.</li></ul><p><b>
OR</b></p><ul><li>
Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures.</li></ul><p><br>
</p><p><b>Preferred Qualifications</b></p><ul><li>
Experience in clinical research setting, including relevant study management experience. &middot; Experience in a healthcare or hospital setting.</li></ul><p><b>
Physical Requirements</b></p><ul><li>
Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues.</li><li>
Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately.</li><li>
Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands.</li><li>
Expected to bend, lift, and carry patient files, documents, equipment, and supplies.</li><li>
Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment.</li><li>
For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles.</li></ul><p></p><p><b>
Location:</b></p>
Intermountain Health Intermountain Medical Center<p></p><p><b>
Work City:</b></p>
Murray<p></p><p><b>
Work State:</b></p>
Utah<p></p><p><b>
Scheduled Weekly Hours:</b></p>
40<p></p><p>
The hourly range for this position is listed below. Actual hourly rate dependent upon experience.</p>
$27.65 - $43.55<p></p><p>
We care about your well-being &ndash; mind, body, and spirit &ndash; which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
</p><p></p><p>Learn more about our comprehensive benefits package here.</p><p></p><p>
Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p><p></p><p>
At Intermountain Health, we use the artificial intelligence (&quot;AI&quot;) platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process.</p><p></p><p>
All positions subject to close without notice.</p></div><p></p>

Clinical Research Project Coordinator

Mission Pet Health

<div><p>Mission Pet Health is seeking an analytically minded individual, with an entrepreneurial spirit, eager to collaborate with all departments to strategically grow our hospitals as we continue to rapidly add to our existing network. The individuals analyses, recommendations, and ability to execute collaboratively will directly impact the growth of our hospitals under their guidance</p><p><b><br>
Responsibilities</b></p><ul><li>
Manage project activities across multiple initiatives simultaneously</li><li>
Partner with Clinical Operations VPs to define initiative priorities, performance expectations, and project timelines</li><li>
Incorporate Leadership Team input to plan and execute Clinical Operations events</li><li>
Communicate project status updates and ensure accountability for tasks with Regional Directors</li><li>
Launch, maintain, and continuously improve Clinical Operations initiatives</li><li>
Lead and manage all project documentation</li><li>
Ensure a high-quality internal client experience across Clinical Operations project platforms</li><li>
Prepare and maintain detailed project status reports</li><li>
Serve as a key point of contact for assigned initiatives</li><li>
Plan and lead project meetings, including capturing notes and distributing recaps to stakeholders</li><li>
Communicate regularly with key stakeholders and Field Leaders on initiative launches, updates, performance, and execution requirements</li></ul><p><b>
Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree (preferred)</li><li>
Based in Birmingham, AL (required) with ~90% in-office schedule and &lt;10% travel</li><li>
Confident communicator (e.g., leading webinars, executive meetings, conference calls, and in-person presentations)</li><li>
Intrinsically motivated self-starter with strong initiative</li><li>
Excellent organizational skills, including multitasking and time management</li><li>
Strong client-facing and collaboration skills</li><li>
Excellent verbal, written, and presentation skills across diverse audiences</li><li>
Proficient in Microsoft Office and Outlook, including Excel, Word, and PowerPoint</li></ul><h3 class="jobSectionHeader"><b>
How You're Supported</b></h3><p><i>
As part of the Mission Pet Health Home Office team, you'll be joining a collaborative group of professionals dedicated to supporting our hospital teams and shaping the future of veterinary medicine.</i></p><div><h5 class="jobSectionHeader"><b>
Competitive Compensation</b></h5><div>
A competitive salary and a comprehensive benefits package.</div></div><div><h5 class="jobSectionHeader"><b>
Total Wellbeing</b></h5><div>
Comprehensive coverage including Health, Dental, and Vision insurance, plus 24/7 access to doctors through Teladoc.</div></div><div><h5 class="jobSectionHeader"><b>
Financial Health</b></h5><div>
Plan for your future with a 401k featuring a generous company match, plus Life Insurance and Short-Term Disability options.</div></div><div><h5 class="jobSectionHeader"><b>
Commitment to Growth</b></h5><div>
Benefit from significant opportunities for upward mobility and career growth within a rapidly expanding organization.</div></div><div><h5 class="jobSectionHeader"><b>
A Collaborative Culture</b></h5><div>
Join a nationwide community of over 20,000 veterinary professionals and a Home Office team that lives by our WAG values.</div></div><div><h5 class="jobSectionHeader"><b>
Valuable Perks</b></h5><div>
Enjoy generous paid time off and company-wide holidays, discounted veterinary care for your pets, and access to an online discount platform.</div></div><h3 class="jobSectionHeader"><b>
About Mission Pet Health</b></h3><p>
Mission Pet Health was founded by veterinarians on the belief that local practices thrive with clinical autonomy, collaboration, and medical excellence. The organization provides world-class support to its 850+ hospital teams on a hyper-local basis so they can focus on what matters most: the medicine, their patients, and their team culture. Learn more at <b>missionpethealth.com</b>.</p><p>
Driving the award-winning culture are the WAG values &ndash; <b>Work Together, Amaze, and Grow</b>. Mission Pet Health is veterinarian-led, people-focused, and on a mission to be the best place to work in veterinary medicine.</p><div><p><b>
EEO Statement:</b> Mission Pet Health is an equal opportunity employer. We embrace diversity and are committed to creating an inclusive environment for all employees.</p></div></div>

Clinical Operations Project Coordinator

The Henry M. Jackson Foundation for the Advancement of Military Medicine

<div><p><b>Join the HJF Team!
</b></p><p>HJF is seeking a <b>Clinical Research Coordinator II </b>that will play a key role in executing a first-of-its-kind clinical trial at Walter Reed National Military Medical Center (WRNMMC). This position will be critical in ensuring compliance, safety, and efficiency at all stages of the study lifecycle, including but not limited to study startup, participant recruitment efforts, data and specimen collection, project tracking, and study operations.
</p><p>This position will be in support of the WRNMMC Directorate of Behavioral Health, Advanced Therapeutics Program. This Clinical Research Coordinator II role will support a clinical trial of MDMA-Assisted Therapy (MDMA-AT) for service members with PTSD, and potentially similar clinical trials in the future.
</p><p>The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.</p></div>

Clinical Research Coordinator II - MDMA-AT

Eximia Clinical Research

<p>Clinical Research Coordinator</p><p>Eximia Clinical Research is looking for a Clinical Research Coordinator to join our team. As the Clinical Research Coordinator, you will act as the subject matter expert and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Eximia Clinical Research&rsquo;s SOPs.</p><p>Role &amp; Responsibilities:</p><ul><li>Serve as lead of studies to execute clinical trials</li><li>Train staff in the conduct of clinical trials, protocol requirements, communication,</li></ul><p>and trial management skills</p><ul><li>Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines</li></ul><p>and Eximia Clinical Research&rsquo;s SOPs</p><ul><li>Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations</li><li>Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable</li><li>Implement and coordinate assigned clinical trials including start up, vendor management,</li></ul><p>subject recruitment, source development review, scheduling subjects, protocol training,<br/>collection of regulatory documents, participating in the ICF process(es), conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.</p><ul><li>Apply project management concepts to manage risk and improve quality in the conduct of a</li></ul><p>clinical research study</p><ul><li>Develop, coordinate, and implement research and administrative strategies to successfully</li></ul><p>manage assigned protocols.</p><ul><li>Communicate effectively and professionally with coworkers, leadership, study subjects,</li></ul><p>sponsors, CROs, and vendors.</p><ul><li>Ensure good documentation in accordance with ALCOA-C principles are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries</li><li>Ensure confidentiality of patient protected health information, sponsor confidential information</li></ul><p>and Eximia Clinical Research confidential information is maintained by all team members</p><ul><li>Develop communication and escalation strategies within teams to that ensure patient safety is</li></ul><p>upheld and all adverse events, serious adverse events, and adverse events of special interest<br/>are followed and reported in accordance with the protocol and Eximia Clinical Research SOPs</p><ul><li>Develop or contribute to development of tools and training to prepare for and/or participate in site audits and inspections</li><li>Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely</li></ul><p>manner as set forth in the Clinical Trial Agreement</p><ul><li>Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs</li></ul><p>as required per protocol, GCP/ICH regulations and IRB requirements.</p><ul><li>Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.</li><li>Incorporate key timelines, endpoints, required vendors, and patient population when planning</li></ul><p>for each assigned protocol.</p><ul><li>Incorporate understanding of how decisions affect the bottom-line including links between</li></ul><p>operations and company&rsquo;s financial performance and how it is essential to create value of all<br/>stakeholders of the organization when planning for each assigned protocol.</p><ul><li>Incorporate understanding of product development lifecycle and significance of protocol</li></ul><p>design including critical data points when planning for each assigned protocol</p><ul><li>Develop Quality Control strategies for team member projects</li><li>Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG,</li></ul><p>lab processing) within scope</p><ul><li>Promote respect for cultural diversity and conventions with all individuals.</li><li>Understand the disease process or condition under study</li><li>Other duties as assigned</li></ul><p>Qualifications</p><p>Education/Experience:</p><ul><li>Bachelor&rsquo;s degree and 6 years as a Clinical Research Coordinator OR</li><li>Associate&rsquo;s degree and 8 years as a Clinical Research Coordinator OR</li><li>High School Graduate and/or technical degree and 10 years as a Clinical Research Coordinator</li></ul><p>Required Licenses/Certifications:</p><ul><li>Phlebotomy if applicable and required by state law</li><li>Intravenous/Intramuscular dose administration and preparation if applicable and required by state law</li><li>Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role</li></ul><p>Required Skills:</p><ul><li>Advanced knowledge of medical terminology</li><li>Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.</li><li>Proficient ability to work in a fast-paced environment</li><li>Advanced verbal, written, and organizational skills</li><li>Advanced interpersonal and communication skills</li><li>Advanced ability to work as a team player</li><li>Advanced ability to read, write, and speak English</li><li>Demonstrated ability to multi-task</li><li>Advanced ability to follow written guidelines</li><li>Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives</li><li>Demonstrated ability to be flexible/adapt as daily schedule may change rapidly</li><li>Must be detail oriented</li><li>Proficient problem solving and strategic decision making ability.</li><li>Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.</li><li>Proficient leader, mentor and team builder</li></ul><p>Required Physical Abilities:</p><ul><li>Sit or stand for long periods of time</li><li>Communicate in person and by telephone</li><li>Limited to moderate walking</li><li>Limited lifting up to 30 pound</li></ul><p>Job Type: Full-time</p><p>Pay: $55,000.00 - $62,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Clinical Research Coordinator

University Health KC

<div><p><b>If you are a current University Health or University Health Physicians employee and wish to be considered, you must apply via the internal career site.</b></p><br>
<p></p>
Clinical Research Coordinator - Women's Health Department<p></p>
101 Truman Medical Center<p></p><h1 class="jobSectionHeader"><b>
Job Location</b></h1>
University Health Truman Medical Center<p></p>
Kansas City, Missouri<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><h1 class="jobSectionHeader"><b>
Department</b></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
Admin Womens Health UHTMC<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><h1 class="jobSectionHeader"><b>
Position Type</b></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
Full time<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><h1 class="jobSectionHeader"><b>
Work Schedule</b></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
8:00AM - 4:30PM<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><h1 class="jobSectionHeader"><b>
Hours Per Week</b></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><h1 class="jobSectionHeader"><b>
Job Description</b></h1></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div><div>
Responsible for performing diverse administrative and clinical responsibilities requiring some analysis, sound judgment, and a high level of knowledge of specific research study protocols, Good Clinical Practice Guidelines, Federal research regulations, and institutional requirements. Responsible for coordination and management of clinical study protocols and along with the research investigator, manages many aspects of the clinical trial and conducts all research activities within an ethically based framework in accordance with federal, state, and local regulations. Function as a liaison between investigators, subjects and sponsors, the Institution(s), Institutional Review Board (IRB) and Privacy Board.</div></div><p></p><div><div><div><div><div><div><div><div><div><p>
Minimum Requirements</p><ul><li><p>
Bachelor&rsquo;s degree in allied health medical field, another related field or licensed LPN.</p></li><li><p>
Ability to prioritize and complete several tasks/projects simultaneously in strict accordance with regulations, policies, and study protocol.</p></li><li><p>
Demonstrated effective verbal/written communication skills, analytical skills, attention to details, and ability to work independently with minimal supervision.</p></li><li><p>
Organization/time management skills and project management skills.</p></li><li><p>
Demonstrated intermediate knowledge of personal computer skills.</p></li></ul><p></p><p>
Preferred Qualifications</p><ul><li><p>
One year clinical research experience.</p></li><li><p>
Clinical Research Coordinator Certification (by either the Association for Clinical Research Professionals or Society of Clinical Research Associates).</p></li><li><p>
Knowledge of Good Clinical Practices, U.S. Department of Health and Human Services Protection of Human Subjects and U.S. Food and Drug Administration regulations, International Conference of Harmonization Guidelines, and the HIPAA Privacy Rule as it impacts clinical research</p></li></ul></div></div></div></div></div></div></div></div></div></div>

Clinical Research Coordinator - Women's Health Department

Temple University Health System

<div></div><div><div><p>The Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s TMS-Pulm/CriticalCare/SleepMed Department is searching for a <b>Clinical Research Coordinator</b> to join our team!</p><p><b>
Become a part of the Temple family and you will have access to the following:</b><br>
<i>Full medical, dental, vision coverage</i><br>
<i>Paid time off</i><br>
<i>11 Paid Holidays</i><br>
<i>Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE</i><br>
<i>A generous retirement plan and so much more!</i><br>
Click here to learn more about the benefits of working at Temple University.</p><p><b>
Salary Grade: T25</b><br>
Learn more about the &ldquo;T&rdquo; salary structure</p><p><b>
Salary Range: $50,000 to $55,000</b><br>
<i>A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant&rsquo;s education and experience, all relevant internal equity considerations, department budget, and funding source.</i></p><p><b>
This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.</b></p><div><b>
Job Details:</b><br>
<ul><li>This is a grant-funded position</li><li>This position requires the following background checks: Cash Handling</li><li>Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator.</li><li>Hybrid work options may be considered depending on study and departmental needs.</li></ul></div><p><b>
Position Summary:</b><br>
The Clinical Research Coordinator works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations.</p><p>
As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured step increase program. We also recognize and reward professional development. Coordinators who successfully earn industry-recognized certifications, such as the Certified Clinical Research Professional (CCRP&reg;) through SOCRA or the Certified Clinical Research Coordinator (CCRC&reg;) through ACRP, may qualify for advancement sooner.</p><p>
At Temple University&rsquo;s Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine.</p><div><b>
Required Education and Experience:</b><br>
Bachelor&rsquo;s degree in a life science or other health professions field<br>
<ul><li>A minimum of three years of related experience</li><li>An equivalent combination of education and experience may be considered.</li></ul></div><p><b>
Responsibilities:</b><br>
The Clinical Research Coordinator performs study coordination tasks independently, following established protocols and procedures. The coordinator makes decisions that require interpretation of policies, procedures, or instructions to ensure accurate and compliant execution of clinical research projects.</p><ul><li>Oversees the day-to-day activities of all assigned research projects and clinical trials.</li><li>Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits.</li><li>Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data.</li><li>Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data.</li><li>Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders.</li><li>Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects.</li><li>May submit IRB paperwork to ensure compliance with IRB regulations.</li><li>Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews.</li><li>Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received.</li><li>May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments.</li></ul>
Adheres with FDA, IRB, Pennsylvania, and other applicable regulations.<br>
<ul><li>May present project updates at clinical research meetings and/or assist with grant or manuscript preparation.</li><li>Performs other duties as assigned</li></ul><div><b>
Required Skills and Abilities:</b><br>
<ul><li>Demonstrated computer skills, and proficiency with MS Office Suite software programs.</li><li>Aptitude in professionalism</li><li>Excellent written and oral communications skills</li><li>Ability to work evenings/weekends hours as needed.</li><li>Knowledge of medical terminology</li><li>Able to resolve problems/issues</li><li>Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants</li><li>Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously.</li><li>Knowledge of IRB and human subject protection</li><li>Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.</li><li>Ability to travel to off-site locations that may not be accessible via public transportation.</li><li>Strong time management skills</li></ul></div><div><b>
Preferred Skills and Abilities:</b><br>
<ul><li>Prior experience with IRB submissions.</li><li>Prior experience processing and shipping biological samples.</li><li>Prior phlebotomy certification or willing to learn.</li><li>Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders.</li><li>Prior Electronic Data Capture (eDC) data entry skills.</li><li>Prior research experience in a healthcare setting.</li><li>Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies.</li></ul></div><p><b>
Temple University</b> is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.</p><p><b>
Compliance Statement: </b>In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.</p><p><b>
Temple University's Annual Security and Fire Safety Report</b> contains statistics, policies, and procedures related to campus safety. Go here to review.</p><p>
You may request a copy of the report by calling Temple University&rsquo;s Department of Public Safety at 215-204-7900.</p></div></div><p></p>

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