director clinical research

Norton Healthcare

<div>Responsibilities:
<div>
The Clinical Research Coordinator (CRC) is responsible, under the direction of the principal investigator, to manage and/or execute all aspects of clinical research protocols in accordance with Standard Operating Procedures (SOPs), Norton Healthcare policy, and FDA regulations and/or GCP guidelines. The CRC functions as a liaison between patients, investigators, local clinic, sponsors, Norton Healthcare Research Office and their research management team. The CRC represents Norton Healthcare Research as assigned clinics within the community.</div>
Qualifications:
<div><b>
Required:</b></div><ul><li>
One year in healthcare</li><li>
Bachelor Degree</li></ul><div><b>
Desired:</b></div><ul><li>
One year in Clinical Research</li><li>
Certified Clinical Research Professional OR Certified Clinical Research Coordinator</li></ul></div>

Coordinator, Clinical Research, Norton Cancer Institute - Downtown

Penn State Health

<p></p><div><div><p><b>Penn State Health</b> - <b>Hershey Medical Center</b></p>
<p><b>Location:</b> US:PA: Hershey
<br>
<b>Work Type:</b> Full Time
<br>
<b>FTE: </b>1.00
<br>
<b>Shift:</b> Day
<br>
<b>Hours:</b> 8-hour shifts
<br>
<b>Recruiter Contact:</b> Denisse M. Rosado at drosado1@pennstatehealth.psu.edu</p>
<p><b>SUMMARY OF POSITION:</b></p>
<p>The Research RN will plan, direct, or coordinate clinical research projects. The Research RN will direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. The research nurse may evaluate and analyze clinical data. The Research RN will monitor study activities to ensure compliance with protocols and will all relevant local, federal and state regulatory and institutional policies.</p>
<p></p><p><b>MINIMUM QUALIFICATION(S):</b></p>
<ul><li>Bachelor's degree in Nursing or equivalent required.</li>
<li>Two (2) years effective experience required.</li>
<li>Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact required.</li>
AHA BLS prior to end of orientation period.<br>
<li>
<br>
</li></ul><p></p><p><b>PREFERRED QUALIFICATION(S):</b></p>
<ul><li>Experience in a clinical research setting preferred</li>
</ul><p></p><p><b>WHY PENN STATE HEALTH?</b></p>
<p>Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community.</p>
<p><b>Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:</b></p>
<ul><li><b><i>Be Well </i></b>with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton).</li>
<li><b><i>Be Balanced </i></b>with Generous Paid Time Off, Personal Time, and Paid Parental Leave.</li>
<li><b><i>Be Secured</i></b> with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection.</li>
<li><b><i>Be Rewarded</i></b> with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program.</li>
<li><b><i>Be Supported</i></b> by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling.</li>
</ul><p></p><p><b>WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?</b></p>
<p>Penn State Hershey Medical Center is Central Pennsylvania&rsquo;s only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth.</p>
<p><b>YOU TAKE CARE OF THEM. WE&rsquo;LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence &ndash; that&rsquo;s Penn State Health. But what makes our healthcare award-winning? That&rsquo;s all you.</b></p>
<p></p><p><i>This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract. </i><i>All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities.</i></p>
<p><i>Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health&rsquo;s policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination.</i></p>
 <p></p><p><b>Union:</b> Non Bargained</p></div></div><div></div>

Coordinator Clinical Research I - Clin HV Cardio Research

<p></p><div><div><p><b>Penn State Health</b> - <b>Hershey Medical Center</b></p>
<p><b>Location:</b> US:PA: Hershey
<br>
<b>Work Type:</b> Full Time
<br>
<b>FTE: </b>1.00
<br>
<b>Shift:</b> Day
<br>
<b>Hours:</b> 8-hour shifts
<br>
<b>Recruiter Contact:</b> Denisse M. Rosado at drosado1@pennstatehealth.psu.edu</p>
<p><b>SUMMARY OF POSITION:</b></p>
<p>Responsible for the facilitation, coordination and implementation of clinical research protocols under physician investigator guidance and delegation, including liaison with faculty and external sponsors/agencies, patient management and education, budget review and quality management.</p>
<p><b>MINIMUM QUALIFICATIONS:</b><br>
<br>
<br>
</p><ul><li>Bachelor's degree in Nursing or Master's degree in Nursing required.</li>
</ul><ul><li>2 years clinical experience as an RN required.</li>
<li>2 years clinical research experience required.</li>
<li>Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact.</li>
<li>Research certification (SoCRA or ACRP) required. If not certified, must be willing to pursue and obtain certification within six months.</li>
</ul><p></p><p><b>WHY PENN STATE HEALTH?</b></p>
<p>Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community.</p>
<p><b>Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:</b></p>
<ul><li><b><i>Be Well </i></b>with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton).</li>
<li><b><i>Be Balanced </i></b>with Generous Paid Time Off, Personal Time, and Paid Parental Leave.</li>
<li><b><i>Be Secured</i></b> with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection.</li>
<li><b><i>Be Rewarded</i></b> with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program.</li>
<li><b><i>Be Supported</i></b> by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling.</li>
</ul><p></p><p><b>WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?</b></p>
<p>Penn State Hershey Medical Center is Central Pennsylvania&rsquo;s only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth.</p>
<p><b>YOU TAKE CARE OF THEM. WE&rsquo;LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence &ndash; that&rsquo;s Penn State Health. But what makes our healthcare award-winning? That&rsquo;s all you.</b></p>
<p></p><p><i>This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract. </i><i>All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities.</i></p>
<p><i>Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health&rsquo;s policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination.</i></p>
 <p></p><p><b>Union:</b> Non Bargained</p></div></div><div></div>

Coordinator Clinical Research II - Clin HV Cardio Research

Denali Health Plant City

<p><b>About Denali </b></p><p>Denali is on a mission to fix what is broken in clinical trials and accelerate therapies from bench to bedside. We are a clinical research site network that focuses on delivering reliable patient enrollment for sponsors faster. At the heart of delivering this mission are the exceptionally talented and dedicated professionals who work at Denali.</p><p>If you want to leave a dent on the world, Denali might be the place for you.</p><p><b>The Opportunity </b></p><p>This is a unique opportunity to take ownership of the successful execution of clinical trials end-to-end in a high-growth environment. It is a large role with significant growth potential as Denali expands its network of sites. If you want to make an impact and grow alongside a mission-oriented organization that is growing rapidly, this might be for you.</p><p><b>Responsibilities </b></p><ul><li>Own key site-level metrics: enrollment rates, screen failure rates, protocol deviations, data query resolution times, and sponsor satisfaction scores.</li><li>Serve as the go-to problem solver when complex site operational challenges arise.</li><li>Serve as a primary point of contact for sponsors, CROs, and CRAs. Lead SQV calls and follow-ups, triage sponsor communications, negotiate contract terms within authority, and authorize study holds when warranted.</li><li>Direct trial execution across sites, including workflow mapping, SIV launches, referral engagement, randomization sign-off, and resolution of protocol-level questions. Ensure no study is paused or terminated for site-controllable reasons.</li><li>Host regular PI touchpoints, attend sponsor and CRA calls, and coach PIs on enrollment performance and expectations.</li><li>Run the site operating rhythm, such as daily stand-ups, weekly all-staff and PI syncs, and cross-site Lead CRC meetings.</li></ul><p><b>Who is a good fit?</b></p><ul><li>Deep understanding of clinical research workflows, GCP/ICH guidelines, FDA regulations, and sponsor expectations.</li><li>Minimum of 2 years of experience managing multiple clinical research sites</li><li>Strong ability to figure out complex problems with limited direction.</li><li>High ownership and bias toward action; comfortable in ambiguity.</li><li>Willing to travel between Atlanta, GA and Plant City, FL as needed</li></ul><p><b>How to Apply</b></p><p>Emailyour CV and detail the following to talent@denali-health.com:</p><ul><li>The maximum # of studies you have managed at once</li><li>The most complex problem you are most proud of solving</li><li>2 references</li></ul><p>Pay: From $100,000.00 per year</p><p>Work Location: In person</p>

Clinical Research Site Director

CommonSpirit Health

<div><b>Job Summary and Responsibilities</b><div><br>
As our Clinical Research Professional, you will be instrumental in advancing medical knowledge by expertly managing and executing clinical trials. You will ensure the highest standards of data integrity, patient safety, and regulatory compliance throughout the research process.<br>
<br>
Every day you will manage trial activities, including participant recruitment, data collection, and documentation, serving as a key liaison for all stakeholders. You will ensure strict adherence to protocols and regulatory requirements from study initiation to completion.<br>
<br>
To be successful in this role, you will bring relevant clinical research experience and a strong understanding of regulatory guidelines (e.g., GCP, FDA). Your exceptional organizational skills, attention to detail, and ability to communicate effectively will be crucial in this dynamic field.</div><ul><li>
Facilitates research activities in partnership with program Medical Director(s) and Research Administration colleagues leveraging clinical experience in related specialty area. Activities include coordination of grant submissions and sponsored clinical trials. Work includes management of site selection process, site initiation visits, and study submissions consistent with regulatory requirements and local policies.</li><li>
Directs, organizes and plans the daily research operational activities of the program and support staff to manage and grow the divisions research activities. Serves as the primary liaison for internal and external project sponsors, routinely informing key stakeholders of project plans, status updates, milestones (including subject enrollment metrics, timely data collection and submission and related contract and/or grant goals) through regular reporting and coordinated discussions.</li><li>
Manages program budget working synergistically with Research Administration to perform and coordinate transactional tasks; i.e., sponsor invoicing, patient financial billing, time and effort reporting, etc. Proactively manages supplies, staffing needs and research portfolio via forecasting reports to ensure a robust study pipeline is in place. Acts as the program fiscal steward and works to promote and grow the research portfolio thru public relations, web-based activities, newsletters and social media outlets.</li><li>
A strong working knowledge of GCP, ICH, DHHS, OIG and FDA regulations and depth of clinical expertise in the assigned area is required along with familiarity of all applicable federal and state regulations and institutional policies. Coordinates the process flow of a study from initial concept to IRB through the final study closure. Facilitates feasibility reviews based upon governing policies.</li></ul><b>
Job Requirements</b><div>
Required</div><ul><li>
Bachelors Degree Of Nursing or Bachelor's prepared healthcare related licensure or an equivalent combination of education and experience</li><li>
Clinical background with a minimum of Five (5) experience in clinical research operations and/or administration</li></ul><div>
Preferred</div><ul><li>
Masters Degree in healthcare or related or business field</li><li>
Eight (8) years of clinical research-related experience</li></ul><br>
<div></div>
Where You'll Work<br>
<h2 class="jobSectionHeader">
Hello Humankindness: Join a Legacy of Healing at Saint Joseph&rsquo;s Hospital and Medical Center (SJHMC)</h2><h2 class="jobSectionHeader">
Ready to make a real difference? Join SJHMC in Phoenix AZ., a 571-bed nonprofit founded by the Sisters of Mercy over 125 years ago. We're more than a hospital; we're a global destination for life-changing care, embracing patients with humankindness.</h2><p>
Here, your calling will flourish. We're not just a workplace; we're a community dedicated to a mission of service.</p><p>
Leaders in Specialized Care:</p><ul><li>
Barrow Neurological Institute (BNI): A world-renowned center for groundbreaking neurological research and innovative treatments.</li><li>
Norton Thoracic Institute (NTI): A national leader in advanced thoracic care with pioneering surgical techniques.</li><li>
Level I Trauma Center: One of Arizona's busiest ERs, providing immediate, comprehensive care for critically injured patients 24/7.</li></ul><p><br>
Why SJHMC?</p><ul><li>
Culture of Excellence &amp; Well-being: We care for our people, fostering professional and personal growth.</li><li>
Community &amp; Collaboration: Be part of a network committed to global health and well-being.</li><li>
Join a Legacy, Shape a Future: Over 20% of our patients travel internationally for our specialized care.</li></ul><p><br>
This is an invitation to join a family of dedicated professionals at the forefront of medical innovation, united by the power of humankindness.</p><b><br>
Pay Range</b><br>
$39.18 - $58.28 /hour</div>

Clinical Research Program Manager

University of Missouri-Columbia

<div>
 Hiring Department
 <br/>
 <br/>
 Department of Orthopaedic Surgery
 <br/>
 <br/>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 The School of Medicine &ndash; Department of Orthopaedic Surgery is seeking a highly motivated, engaged, and committed Research Specialist II who is interested in joining a fast-paced, highly productive team.
 <br/>
 <br/>
 Our Orthopaedic service talent teams include: Attending Physicians, Fellow/Resident Physicians, Extender Practitioners, Nurses, ATC/OTCs, Clinical Administrative Coordinators, Research Faculty, Research Technical Teams, and Students. Our clinicians have clinical locations in Columbia, Jefferson City, Boonville, and Springfield. The ideal candidate will play an instrumental role in the success of sustaining our department&rsquo;s mission: advance the clinical, research and teaching components of Orthopaedic Surgery at the University of Missouri.
 <br/>
 <br/>
 This position will partner with departmental staff to support the overall culture and advancement of the Missouri Orthopaedic Institute and C3 Orthopaedics Initiative (Comprehensive, Cutting Edge, Caring Culture), which fosters a fast learning and continuously improving organization to further our mission.
 <br/>
 <br/>
 We are looking for someone with the following leadership qualities which are needed in our growing, fast- paced work environment:
 <br/>
 <br/>
 <ul>
  <li>
   Commitment and Passion
  </li>
  <li>
   Transparency
  </li>
  <li>
   Initiative for Action
  </li>
  <li>
   Ownership/Accountability
  </li>
  <li>
   Positive Energy/Inspire Others
  </li>
  <li>
   Delegation and Empowerment
  </li>
  <li>
   Teamwork focus
  </li>
  <li>
   Creativity and Innovation
  </li>
  <li>
   Strategic Planning
  </li>
  <li>
   Problem Solving
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Overview
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Contribute to a positive, efficient and high-functioning clinical research work environment; Monitor research related processes/work flow to improve as necessary
  </li>
  <li>
   Initiate and engage in consistent communication and collaboration with clinical staff, research team colleagues and research division leadership
  </li>
  <li>
   Be the expert research team member regarding: orthopaedic surgery medical knowledge, clinical trial coordination, training colleagues/students/new clinical trial coordinators on applicable research procedures, and clinical trial coordination rules/regulations/guidelines
  </li>
  <li>
   Work regularly and successfully with various data capture/research and analytics platforms and improve workflow processes when necessary
  </li>
  <li>
   Be the expert on assigned study protocols and projects
  </li>
  <li>
   Pre-screen clinical patients for potential research enrollment per study protocol, guidelines, and IRB (institutional review board) approval
  </li>
  <li>
   Enroll research subjects into various research studies, which includes a compliant consent process (or assisting PI/Co-I with enrollment and consent)
  </li>
  <li>
   Completion of research follow-up visits per protocol
  </li>
  <li>
   Research specimen collection/mobilization in adherence with environmental health and safety protocols
  </li>
  <li>
   Complete first draft services for grant proposals, abstracts, manuscripts
  </li>
  <li>
   Practice accurate and timely reporting to the IRB as applicable
  </li>
  <li>
   Submit IRB applications, amendments, personnel change forms and annual reviews
  </li>
  <li>
   Work closely with faculty/principal investigators and their clinical staff, residents and fellows, other research personnel and research financial professionals to assure compliance with study protocols, research guidelines, policies and regulations
  </li>
  <li>
   Correspondence with external clinical research associates and sponsors
  </li>
  <li>
   Meticulous and organized documentation of research activity, data collection and adverse events
  </li>
  <li>
   Possess the flexibility to cross-train for necessary back-up systems in times of high case load in clinical research
  </li>
  <li>
   Display the versatility necessary to work in multiple environments (Operating Room, Clinic, Inpatient Areas)
  </li>
  <li>
   Acquire and use knowledge of institutional and federal regulations and guidelines related to human research
  </li>
  <li>
   Stay compliant with Institutional Research training and IRB CITI training
  </li>
  <li>
   Assure research subject safety at all times
   <br/>
   <br/>
  </li>
 </ul>
 Shift
 <br/>
 <br/>
 Monday &ndash; Friday
 <br/>
 <br/>
 8:00 a.m. &ndash; 5:00 p.m.
 <br/>
 <br/>
 With the ability to be flexible when needs arise.
 <br/>
 <br/>
 <strong>
  Minimum Qualifications
  <br/>
  <br/>
 </strong>
 Bachelor's degree or an equivalent combination of education and relevant experience and at least 1 year of experience from which comparable knowledge and skills can be acquired is necessary.
 <br/>
 <br/>
 Anticipated Hiring Range
 <br/>
 <br/>
 Salary Range: $19.25 - $27.40 hourly
 <br/>
 <br/>
 Grade: GGS - 008
 <br/>
 <br/>
 University Title: RESEARCH SPECIALIST II
 <br/>
 <br/>
 Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.
 <br/>
 <br/>
 Application Materials
 <br/>
 <br/>
 In addition to the Online Application, please provide Resume.
 <br/>
 <br/>
 Benefit Eligibility
 <br/>
 <br/>
 This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty &amp; Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits.
 <br/>
 <br/>
 <strong>
  Equal Employment Opportunity
  <br/>
  <br/>
 </strong>
 The University of Missouri is an Equal Opportunity Employer.
 <br/>
 <br/>
 To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.
</div>


Research Specialist II

Pinnacle Clinical Research

<div><div><b>Summary: </b>The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials and ensure that pre-established work scope, study protocol, and regulatory requirements are followed. They will recruit and screen study participants, document and report on the daily operations of a study, and report on participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities promptly. This position is responsible for a broad range of duties involving confidential information. Strong communication and organizational skills are essential, along with a proactive, problem-solving mindset.</div><div></div><div><br>
The Clinical Research Coordinator must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high-quality participant care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, and external vendors, and, therefore, must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team player, and able to manage multiple projects effectively and efficiently. This role reports directly to the Clinical Operations Manager.</div><div></div><div><b><br>
Duties and Responsibilities:</b></div><div></div><div><br>
Clinical Trial Execution:</div><ul><li>
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Operations Manager, and Site Director or Regional Director</li><li>
Maintain participant privacy and data confidentiality, complying with the appropriate sponsor requirements and regulations, which include the FDA, ICH GCP, HIPAA, institutional review board determinations, and institutional policies and procedures</li><li>
Complete study-directed assessments with participants, which may include, but are not limited to, informed consent, medical history, adverse events, Fibroscan, memory screen, test article handling, appointment scheduling, records review, treatment coordination, and collecting vital signs</li><li>
Complete documentation and data management-related tasks as instructed by supervisor and compliance leadership in accordance with GCP and other regulatory guidelines</li><li>
Function as a liaison with pharmaceutical sponsors and external vendors, including but not limited to, participating in monitoring visits and audits</li><li>
Responsible for participant management and engagement from the recruitment of study participants to study completion, as applicable.</li><li>
Respond to internal and external requests for information promptly</li><li>
Identify opportunities to improve participant care and satisfaction</li><li>
With a solutions-oriented and collaborative mindset, resolve study-related challenges within a reasonable time set by the supervisor</li><li>
Establish, develop, and maintain productive relationships with internal and external personnel to achieve a high standard of research outcomes.</li><li>
Coordinate multiple projects with competing priorities and deadlines as needed, based on clinical trial protocol directives and study volume</li><li>
Attends the investigator&rsquo;s meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by monitors or sponsor representatives as appropriate</li><li>
Track enrollment status reports to ensure study sites stay on track to meet enrollment goals</li><li>
Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status is kept current</li></ul><p></p><div><br>
 Administration:</div><ul><li>
Create memos, emails, and letters related to study activities</li><li>
Create and maintain reports and/or spreadsheets as requested</li><li>
Assist regulatory personnel in maintaining study documents and ensure electronic regulatory documents are saved and uploaded appropriately</li><li>
Responsible for reporting safety information to regulatory agencies</li><li>
Perform quality checks on source documents specific to the study</li><li>
Assist with the Corrective and Preventive Action Plan (CAPA) process as needed</li></ul><div></div><div><i><br>
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.</i></div><div></div><div><b><br>
Education / Experience:</b></div><ul><li>
High school diploma or general education degree (GED) required</li><li>
Bachelor&rsquo;s Degree in a scientific area of study preferred or equivalent combination of education, training, and experience</li><li>
1 year of experience as a Clinical Research Assistant or Coordinator</li><li>
1-2 years of experience in Clinical Research</li><li>
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS</li><li>
Must have strong knowledge of ICH/GCP guidelines</li><li>
Must complete GCP training before interacting with participants and must recertify every 2 years or as applicable</li><li>
Trained and certified in the administration of Fibroscan and memory screens as required by the study portfolio and individual experience. Training to be provided</li><li>
Must have basic life support (BLS) training, provided during onboarding</li><li>
Demonstrated organizational skills and outstanding time management, including keen attention to detail, with the ability to track multiple projects at one time</li><li>
Strong written and oral communication skills</li><li>
Knowledge of basic medical terminology</li><li>
Possess impeccable integrity and personal and professional values that are consistent with PCR&rsquo;s high standards and mission</li><li>
Comply with the company policies, code of ethics, and guiding values always</li><li>
Proficient in Spanish and English preferred</li></ul><div></div><div><b><br>
Supervisory Responsibilities: </b>None</div><div><b><br>
</b></div><div><b>Certificates and Licenses: </b>Valid Driver&rsquo;s License</div><div></div><div><b><br>
Knowledge, Skills, and Other Abilities:</b></div><div><ul><li>
Must be able to effectively communicate with all levels of internal and external contacts</li><li>
Demonstrated ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.</li><li>
Ability to work independently and multitask in a fast-paced team environment</li><li>
Strong people skills, including the ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment</li><li>
Must possess a positive, friendly, and professional demeanor, particularly when interacting with research participants</li><li>
Must be able to work independently and collaborate with a team</li><li>
Ability to interpret clinical research protocols</li><li>
Strong problem-solving and decision-making skills, particularly when under pressure</li><li>
Proactive at identifying, addressing, and solving issues in real time</li><li>
Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment</li></ul></div><div></div><div><b><br>
Work Environment and Physical Demands:</b></div><div>
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</div><div><ul><li>
Work is performed in an office/laboratory and/or a clinical environment.</li><li>
Exposure to biological fluids and/or bloodborne pathogens.</li><li>
Personal protective equipment is required, such as protective eyewear, garments, and gloves.</li><li>
Occasional travel may be required, domestic and/or international.</li><li>
Ability to work in an upright and/or stationary position for 6-10 hours per day.</li><li>
Frequent mobility required.</li><li>
Occasional squatting, kneeling, or bending.</li><li>
Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.</li></ul></div><div></div><div><b><br>
Benefits of working at Summit Pinnacle Clinical Research:</b></div><div><ul><li><i>
401k</i></li><li><i>
Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance</i></li><li><i>
3 weeks of paid time off</i></li><li><i>
14 paid company holidays</i></li><li><i>
Scrub uniform voucher (specific positions apply)</i></li><li><i>
And more!</i></li></ul></div><div></div><div><br>
Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status, or any other protected Federal, State/Province, or Local status unrelated to the performance of the work involved.</div></div><div></div>

Clinical Research Coordinator

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