clinical research director

Tigerlily Foundation

<p></p><div><div><div>The Director of Clinical Trial Access and Partnerships lead Tigerlily Foundation&rsquo;s work to expand equitable access to clinical trials as part of the breast cancer care journey. This role focuses on connecting women of color, young women, and other marginalized populations to accurate information, supportive resources, and opportunities to participate in trials when they choose.</div>
</div><div><h3 class="jobSectionHeader"><b>About The Tigerlily Foundation</b></h3>
<div><div>Tigerlily Foundation is a national foundation providing education, awareness, advocacy and hands-on support to young women&ndash;before, during and after cancer, as well as empowering women throughout their health journey. Through our programs, we seek to educate and empower women of all backgrounds, including those at heightened risk, those facing health disparities, and those with less access to care.
</div></div></div><div><h3 class="jobSectionHeader"><b>Description</b></h3><br>
<div></div><div><div><br>
<h1 class="jobSectionHeader"><b>APPLICATION DEADLINE: November 17, 2025</b></h1><div></div><div><b><br>
About Tigerlily Foundation</b></div><div>
Tigerlily Foundation is a national breast cancer organization dedicated to educating, advocating for, empowering, and supporting young women, especially women of color and other underserved populations, before, during, and after breast cancer. Through our programs, we strive to transform lives and systems by addressing disparities and creating equitable access to care, research, and clinical trials.</div><div></div><div><b><br>
Position Summary</b></div><div></div><div><br>
The <b>Director of Clinical Trial Access and Partnerships</b> lead Tigerlily Foundation&rsquo;s work to expand equitable access to <b>clinical trials</b> as part of the breast cancer care journey. This role focuses on connecting women of color, young women, and other marginalized populations to accurate information, supportive resources, and opportunities to participate in trials when they choose. The Director designs and implements national strategies that improve awareness, access, and representation, while ensuring all outreach and engagement activities are transparent, ethical, and compliant.</div><div>
This position also oversees the lifecycle of community-to-trial engagement, from education and identification through referral, tracking, and reporting. It ensures that data systems and communications meet HIPAA, IRB, and Good Clinical Practice standards, and that all activities uphold Tigerlily&rsquo;s commitment to health equity, inclusion, and cultural competence.</div><div>
Tigerlily Foundation does not conduct clinical trials, but partners with funders, CROs, research teams, and clinical sites to ensure that historically underrepresented patients are fully informed about clinical trials as an option in their care. The Director works closely with the <b>Director of Community Engagement and Clinical Trial Equity</b> to align education, outreach, and data-driven approaches that strengthen trust, transparency, and participation.</div><div></div><div><b><br>
Key Responsibilities</b></div><ul><li>
Design and lead national strategies that increase awareness and equitable access to clinical trials for underrepresented communities.</li><li>
Build and sustain partnerships with funders, CROs, research teams, and clinical sites to align access and engagement goals.</li><li>
Develop and manage compliant outreach and referral processes in collaboration with sponsors and research partners.</li><li>
Coordinate with Peer Navigators and outreach staff to ensure accurate study information, clear communication, and culturally responsive engagement.</li><li>
Oversee data management, reporting, and privacy compliance across all program activities, ensuring alignment with HIPAA, IRB, and Good Clinical Practice standards.</li><li>
Maintain and optimize CRM systems such as Monday.com to track outcomes and report metrics to funders and internal stakeholders.</li><li>
Contribute to grant proposals, renewals, and reports by providing validated data, access outcomes, and partnership impact.</li><li>
Develop accessible, culturally grounded educational materials to promote informed decision-making about clinical trials.</li></ul><div></div><div><b><br>
Qualifications</b></div><ul><li>
Minimum 7 years of experience in clinical research, patient navigation, public health, or health equity programs.</li><li>
Proven track record advancing <b>health equity and inclusion for marginalized communities</b>, particularly women of color and those facing barriers to care.</li><li>
Support <b>funder impact reports, grant deliverables, and renewal proposals</b> by providing validated data, access outcomes, and partnership impact.</li><li>
Strong understanding of HIPAA, IRB, and Good Clinical Practice standards.</li><li>
Demonstrated skill in <b>data management, reporting, and CRM system use</b> (experience with Monday.com preferred).</li><li>
Ability to analyze program data, prepare accurate reports, and use insights to drive strategy.</li><li>
Exceptional written and verbal communication skills with the ability to translate complex information clearly and build trust across diverse communities.</li><li>
Deep cultural competence and experience engaging underrepresented populations in healthcare or clinical research settings.</li><li>
Master&rsquo;s degree in public health, Clinical Research, or related field preferred; certification in human subjects protection (e.g., CITI) strongly desired.</li></ul></div></div></div></div><div></div>

Director of Clinical Trial Access and Partnerships

Summit Therapeutics, Inc.

<div>
 <strong>
  About Summit
  <br/>
  <br/>
 </strong>
 Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational
 <br/>
 <br/>
 bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
 <br/>
 <br/>
 Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
 <br/>
 <br/>
 <ul>
  <li>
   HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
  </li>
  <li>
   HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  </li>
  <li>
   HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
   <br/>
   <br/>
  </li>
 </ul>
 Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit&rsquo;s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food &amp; Drug Administration (FDA) for the HARMONi clinical trial setting.
 <br/>
 <br/>
 <strong>
  Overview Of Role
  <br/>
  <br/>
 </strong>
 The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be partnering with clinical operations, translational, and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The Director, Clinical Scientist will strive to drive study enrollment, and build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Summit colleagues. The Director, Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.
 <br/>
 <br/>
 <strong>
  Role And Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
  </li>
  <li>
   Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
  </li>
  <li>
   Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
  </li>
  <li>
   Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
  </li>
  <li>
   Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  </li>
  <li>
   Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
  </li>
  <li>
   Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
  </li>
  <li>
   Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  </li>
  <li>
   Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
  </li>
  <li>
   Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  </li>
  <li>
   Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  </li>
  <li>
   All other duties as assigned
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience, Education And Specialized Knowledge And Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   MS (or equivalent) required,
  </li>
  <li>
   PhD, PharmD, or MD preferred
  </li>
  <li>
   5+ years overall related experience with PhD or like degree; Minimum of 2 years&rsquo; experience in conducting / supporting oncology/hematology clinical studies
  </li>
  <li>
   Excellent written and verbal communication skills
  </li>
  <li>
   Expertise in interpreting immunology/immuno-oncology translational data in addition to clinical data
   <br/>
   <br/>
  </li>
 </ul>
 The pay range for this role is $186,000-$233,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
 <br/>
 <br/>
 Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit&rsquo;s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
</div>


Director, Clinical Scientist

National Reference Laboratory

<div></div><div><div><div><div><div><div><div>ID</div>
<div>2025-4834
</div></div><div><div>Category</div>
<div>Clinical Operations
</div></div><div><div>Asset : Name</div>
<div>IROS (Insights Research Organization &amp; Solutions)
</div></div><div><div>City</div>
<div>Abu Dhabi
</div></div></div></div></div></div><h2 class="jobSectionHeader"><b>Overview
</b></h2><div><div><div><div>M42&rsquo;s Integrated Health Solutions (IHS) platform drives transformative national programs and population health initiatives, addressing global health challenges through precision, prevention, and predictive care. Flagship initiatives include the Emirati Genome Program (EGP), the Abu Dhabi BioBank, and Biogenix Labs, which together advance personalized medicine, drug discovery, and biobanking excellence. Environmental Sciences complements these efforts by analyzing non-human factors impacting health, while IROS (Integrated Research Organization Solutions) powers clinical innovation through high-quality research.</div><div></div><div><br>
We are seeking a Clinical Research Manager to join IROS, the UAE&rsquo;s first homegrown Contract Research Organization (CRO), dedicated to raising the bar in clinical trial management and research excellence.</div>
</div></div></div><h2 class="jobSectionHeader"><b>Responsibilities
</b></h2><div><div><div><ul><li>Lead, mentor, and manage a team of Clinical Research Associates (CRAs).</li><li>
Oversee clinical trial execution with adherence to GCP, regulations, and SOPs.</li><li>
Collaborate with Clinical Project Managers to align on deliverables and resources.</li><li>
Conduct on-site performance evaluations and manage staff development plans.</li><li>
Drive process improvements and ensure consistent compliance across studies.</li><li>
Handle administrative oversight, including approvals, performance reviews, and onboarding.</li></ul>
</div></div></div><h2 class="jobSectionHeader"><b>Qualifications
</b></h2><div><div><div><ul><li>Bachelor&rsquo;s degree in Life Sciences (or equivalent).</li><li>
5+ years&rsquo; experience as a CRA/Monitor and at least 4 years in a lead/project role.</li><li>
Proven ability to lead teams within global/multi-regional clinical trials.</li><li>
Strong knowledge of clinical research processes, ICH/GCP guidelines, and regulatory requirements.</li><li>
Excellent communication, organizational, and leadership skills.</li><li>
Experience with electronic data capture (EDC) and budget management preferred.</li></ul></div></div></div></div><div></div>

Clinical Research Manager

Medtronic

<div><p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
</p><p></p><h1 class="jobSectionHeader"><b>A Day in the Life
</b></h1><p><b>Careers That Change Lives
</b></p><p>Join a mission-driven industry leader in medical technology and solutions to help drive innovation and transform the healthcare landscape. As <b>Clinical Research &amp; Medical Sciences Director </b>you will oversee both clinical and medical sciences aspects of running the medical organization in the TuRMECA region. Reporting to Chief Medical Officer Global Regions and VP Clinical Research &amp; Medical Sciences, you will lead the development and execution of clinical research and medical sciences agenda in TuRMECA region to enable patient access to innovative medical technologies.
</p><p></p><p><b>A Day in Life
</b></p><ul><li>Provides Clinical/Medical Leadership at Business Reviews and discussions with the respective Country Leaders in the TuRMECA region.
</li><li>As a Leader within the TuRMECA regional organization, contributes to the development of a Clinical &amp; Medical affairs strategy and execute them in their sub-region.
</li><li>Is seen as the Voice of the Patient and the HCP.
</li><li>Provides Strategic Leadership for the development of Clinical strategy across OUs relevant to the region in Medtronic sponsored studies, Collaborative Research and ERPs including execution of Clinical Research and Medical Affairs.
</li><li>Ensures that the studies are scientifically valid and meet all relevant regulatory requirements and be conducted within ethical guidelines.
</li><li>Leads execution for both local and global studies, manages clinical research projects across Medtronic therapies across multiple businesses.
</li><li>Ensures that all clinical studies are published based on a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.
</li><li>Partners with the OUs/Marketing regionally to seek insights and disseminate the published data both globally and regionally. This may be done through Advisory Boards (ABs) to seek advice, Focus Group Discussions (FGDs), Continuing Medical Education (CMEs), Round Table Discussions (RTDs), and webinars for safe and effective use of our products.
</li><li>Partners with Regulatory to contribute and partnering to implement regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.
</li><li>Develop the Healthcare Professional (HCPs) and Key Opinion Leaders network and lead a strategic partnership and engagement.
</li><li>Develops and maintains a deep knowledge and understanding of the science behind our products and is seen as an internal expert. To also act as a Speaker in scientific meetings as the voice of the company.
</li><li>Responsible for the governance and compliance within the region. Ensures that all activities are executed as per the Medtronic Business Code of Conduct and local laws and regulations.
</li><li>Utilizes advanced subject matter expertise to provide medical input to various functions (General Management, Global Strategy &amp; Portfolio Management, Business Development &amp; Licensing, Research &amp; Development, &amp; Marketing) and Organizational Units to facilitate insightful decision-making and enable achievement of business objectives.
</li><li>Ensures effective objective value propositions are developed and articulated for Medtronic technologies to stakeholders (patients, health care providers, payers, government agencies, health technology assessment organizations, public) through appropriate channels.
</li><li>Responsible to interpret clinical trials/research, establishes and approves scientific methods for design and implementation of clinical protocols, and final reports.
</li><li>Proactively develops current competitive intelligence in our product space.
</li><li>Represents Medtronic from Clinical Research and Medical Sciences perspective within the region and collects feedback from local customers and authorities.
</li><li>Builds and maintains a strong network and close relationship with the various internal and external parties
</li></ul><p></p><p><b>Qualifications/ must have
</b></p><ul><li>10 years of relevant experience within clinical research &amp; medical sciences with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience.
</li><li>University degree &ndash; medical or scientific discipline.
</li><li>Proven strategic thinking, stakeholder management, and team leadership.
</li><li>Fluent in English and local language.
</li><li>Strong communication and networking skills.
</li></ul><p></p><p><b>Nice to have
</b></p><ul><li>Experience in international and cross-functional environments preferred
</li></ul><p></p><p>To be successful in this role you must be an excellent communicator, able to drive change by influence (internally as well as externally) and have strong managerial skills/experience.
</p><p></p><p><b>Physical Job Requirements
</b><br>
<br>
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
</p><p></p><h1 class="jobSectionHeader"><b>Benefits &amp; Compensation
</b></h1><p><b>Medtronic offers a competitive Salary and flexible Benefits Package
</b><br>
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.<br>
<br>
</p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
<p></p>This position is eligible for an annual long-term incentive plan.
<p></p><h1 class="jobSectionHeader"><b>About Medtronic
</b></h1><p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
<br>
Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
<br>
We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.</p></div><p></p>

TuRMECA Clinical Research and Medical Science Director

Empowered Dental Consulting

<p><b>About Us</b><br/>Brevard Health Alliance is a nationally recognized Federally Qualified Health Center committed to improving health outcomes through compassionate, comprehensive care. We are seeking a visionary Dental Clinical Director to lead our Department of Dentistry, drive strategic growth, and elevate the quality of oral health services across our organization. This is an exceptional opportunity for an accomplished dental leader to shape programs, mentor teams, and influence community health at scale.</p><p><b>The Opportunity</b></p><p>As the Dental Clinical Director, you will be the architect of our oral health strategy. You will provide clinical excellence, operational oversight, and executive-level leadership to ensure best-in-class care for thousands of patients annually. This role blends clinical practice (60%) with strategic leadership (40%), giving you the platform to impact patient outcomes, team performance, and organizational success.</p><p><b>What You&rsquo;ll Lead</b></p><p><b>Strategic Leadership &amp; Departmental Growth</b></p><ul><li>Define and execute the vision for dental services across multiple locations</li><li>Ensure departmental productivity, quality benchmarks, and provider retention goals are achieved</li><li>Participate in executive planning and contribute to system-wide initiatives</li></ul><p><b>Clinical Excellence &amp; Mentorship</b></p><ul><li>Provide direct patient care while setting the standard for clinical quality</li><li>Mentor and develop general dentists, hygienists, and dental assistants</li><li>Oversee audits, peer reviews, and workflow optimization to maintain excellence</li></ul><p><b>Organizational Representation &amp; Community Impact</b></p><ul><li>Serve as the face of the dental program in professional and community forums</li><li>Build partnerships with local dental societies and external organizations</li><li>Lead community outreach efforts to expand access to care and enhance public health</li></ul><p><b>Operational &amp; Quality Oversight</b></p><ul><li>Develop policies, procedures, and staffing plans to drive efficiency</li><li>Monitor appropriateness of referrals and service utilization</li><li>Actively participate in quality improvement initiatives and administrative committees</li></ul><p><b>Why Lead in Our Organization?</b></p><ul><li>Impact: Shape the future of oral health in Brevard County and beyond</li><li>Leadership Platform: Serve as a key member of the executive team with direct influence on organizational strategy</li><li>Mission-Driven Work: Join a team passionate about health equity and community care</li><li>Competitive Compensation &amp; Benefits: Comprehensive package including relocation assistance</li></ul><p>Job Type: Full-time</p><p>Pay: Up to $210,000.00 per year</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Relocation assistance</li><li>Retirement plan</li></ul><p>Work Location: In person</p>

Dental Clinical Director

WebMD

<div><p>Medscape, a division of WebMD, develops and hosts physician portals and related mobile applications that make it easier for physicians and healthcare professionals to access clinical reference sources, stay abreast of the latest clinical information, learn about new treatment options, earn continuing medical education credits and communicate with peers.
<br>
<br>
<b>WebMD is an Equal Opportunity/Affirmative Action employer and does not discriminate on the basis of race, ancestry, color, religion, sex, gender, age, marital status, sexual orientation, gender identity, national origin, medical condition, disability, veterans status, or any other basis protected by law.</b></p><div><div><b>
Position Overview:</b></div><ul><li>
Partner with Sales and Management teams in defining, implementing and delivering analytical capabilities for Medscape&rsquo;s growing business</li><li>
Partner with sales team to develop and present comprehensive, value-driven physician/HCP-targeted marketing campaigns for Medscape&rsquo;s most strategic client-partnerships</li><li>
Provide oversight and hands-on management to strategic deals throughout their life cycle across pre-sale, post-sale execution and measurement, and renewal stages</li><li>
Partner with colleagues on cross-functional teams (e.g. Statistical Services, Market Research, Business Intelligence) to align marketing strategies and plans, build custom marketing solutions, and implement analytics-driven optimizations to maximize ROI and mitigate risk for Medscape</li><li>
Conduct thorough analyses of campaign performance and strategy to generate actionable intelligence and clearly communicate and present insights to respective clients</li><li>
Develop sound understanding of Medscape&rsquo;s product portfolio, historical performance according to various therapeutic categories and audience segments, promotional impact measurement methodology, and data capabilities of various analytics partners</li><li>
Leverage learnings and best practices from current business to expand similar capabilities into other parts of the business</li><li>
Tackle complex and ambiguous problems with a strategic and entrepreneurial mindset</li><li>
Create recommendations and action plans for solving problems</li><li>
Travel as needed for important client meetings (10% - 20%)</li></ul><div><b>
Minimum Qualifications:</b></div><div><ul><li>
Bachelor&rsquo;s Degree or equivalent required</li><li>
5+ years relevant experience</li><li>
Outstanding analytical, problem-solving, and critical thinking skills</li><li>
High energy, disciplined self-starter with an entrepreneurial spirit and proven leadership skills</li><li>
Experience with marketing and business metrics and analytics</li><li>
Excellent verbal and written communication skills, with experience presenting to clients, partners, and stakeholders</li><li>
Highly proficient in Microsoft Suite, including Excel and PowerPoint</li></ul></div><div>
</div><div><b>
Preferred Qualifications:</b></div><div><ul><li>
Experience in digital healthcare marketing</li><li>
Experience building, interpreting and presenting data driven dashboards</li></ul></div><div>
</div></div><div><b>
Compensation:</b> $120,000 - $130,000</div><div>
</div><div><b>
Bonus Eligible:</b><br>
This position is also eligible for a discretionary company bonus, based upon business results.</div><div>
</div><div><b>
Benefits:</b></div><ul><li>
Employees in this position are eligible to participate in the company sponsored benefit programs, including the following within the first 12 months of employment:</li><li>
Health Insurance (medical, dental, and vision coverage)</li><li>
Paid Time Off (including vacation, sick leave, and flexible holiday days)</li><li>
401(k) Retirement Plan with employer matching</li><li>
Life and Disability Insurance</li><li>
Employee Assistance Program (EAP)</li><li>
Commuter and/or Transit Benefits (if applicable)</li></ul><div><i>
Eligibility for specific benefits may vary based on job classification, schedule (e.g., full-time vs. part-time), work location and length of employment.</i></div></div>

Associate Director, Commercial Clinical Strategy

Evolution Research Group

<div><p><b>About Company:</b></p><p>
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.</p><p><b>
Why join us?</b> We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.</p><p><b>
Job Description:</b></p><p>
The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.</p><p><b>
Responsibilities:</b></p><p><b>
General</b></p><ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul><p><b>
Study Management</b></p><ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Perform study close-out procedures.</li><li>
Store study records appropriately</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul><p><b>
Skills and Qualifications:</b></p><ul><li><b>
Education and experience</b><ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li><b>
Requirements</b><ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator-FT CRC

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