clinical research specialist

University of Rochester

<p></p><div><p>As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
</p><p></p><p><b>Job Location (Full Address):
</b></p><p></p>601 Elmwood Ave, Rochester, New York, United States of America, 14642
<p></p><p><b>Opening:
</b></p><p></p><p>Worker Subtype:
</p>Regular
<p></p><p>Time Type:
</p>Full time
<p></p><p>Scheduled Weekly Hours:
</p>40
<p></p><p>Department:
</p>400089 Dev &amp; Behav Pediatrics
<p></p><p>Work Shift:
</p>UR - Day (United States of America)
<p></p><p>Range:
</p>UR URG 107
<p></p><p>Compensation Range:
</p>$47,972.00 - $67,161.00
<p></p><div><div><div><div><div><div><div><p><i>The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
</i></p></div></div></div></div></div></div></div><p></p><p><b>Responsibilities:
</b></p><p></p>Assumes responsibility for the data management of clinical research protocols. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates and organizes data entry plans to manage assigned caseloads. Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
<p></p><p><b>ESSENTIAL FUNCTIONS
</b></p><ul><li>Assists in conducting quality checks for data accuracy with data source records as assigned. Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
</li><li>Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately. Manages a workload of studies commensurate to level of experience. Answers data clarifications for each study. Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. Develops source data worksheets specific to each assigned study. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
</li><li>Maintains study binders and filings according to protocol requirements and department policy. Prepares source documentation logs for review by trial investigators by extracting this information from available source documents. Updates data and safety related information in OnCore and collaborates with the trial investigators for review and submission to the applicable sponsor(s) and regulatory authorities. Maintains screening, enrollment, and other sponsor and/or protocol specific logs.
</li><li>Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
</li><li>Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
</li>Other duties as assigned.<br>
<li>
</li></ul><p><br>
<b>MINIMUM EDUCATION &amp; EXPERIENCE
</b></p><ul><li>Bachelor's degree and 1 year of relevant experience required
</li>Or equivalent combination of education and experience<br>
<li>
</li></ul><p><br>
<b>KNOWLEDGE, SKILLS AND ABILITIES
</b></p><ul><li>Skill in completing assignments accurately and with attention to detail required
</li><li>Ability to understand and follow standard research protocols and procedures required
</li><li>Ability to process and handle confidential information with discretion required
</li><li>Commitment to the University&rsquo;s core values required
</li><li>Ability to work independently and/or in a collaborative environment required
</li><li>Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
</li><li>Strong interpersonal, communication, and organizational skills required
</li><li>Highly collaborative, works well in teams required
</li><li>Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
</li></ul><p></p><p>The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University&rsquo;s Mission to Learn, Discover, Heal, Create &ndash; and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.</p></div><p></p>

Clinical Research Data Specialist II

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

ProMedica

<div><p><b>Location:</b></p>
Toledo Hospital<p><b>
Department:</b></p>
Vascular Surgery<p><b>
Weekly Hours:</b></p>
40<p><b>
Status:</b></p>
Full time<p><b>
Shift:</b></p>
Days (United States of America)<p></p><p><b>
Job Summary:</b></p><div><p>
As the Clinical Research Scientist, you implement investigator-initiated clinical research studies through collaboration with physicians, researchers, and research staff.</p></div><p></p><div><p>
You will develop hypotheses, research methodology, study design, statistical analysis, writing and publication of results.</p></div><p></p><div><p>
The above summary is intended to describe the general nature and level of work performed by the positions. It should not be considered exhaustive.</p></div><p></p><div><p><b>
REQUIREMENTS</b></p><ul><li><b>
Education</b>: PhD Required</li><li><b>
Skills</b>: Statistical, analysis background with experience in SQL databases, experience in medical writing. Strong inter-personal skills both written and verbal required, effective verbal and written communication skills in English required. Ability to perform statistical analyses, including sample size estimation, for study design and analysis of results.</li><li><b>
Years of Experience</b>: 5 years experience in scientific research methodology and design and data analysis. Proven track record of manuscript preparation and publication. Experience working in medical/healthcare setting.</li></ul><p></p><p><b>
PREFERRED REQUIREMENTS</b></p><ul><li>
Education: PhD</li><li>
Skills: Sponsored clinical trial experience desired and familiarity with clinical setting, medical terminology, and knowledge of vascular disease. Excellent computer skills including Epic EMR, Red Cap, and experience with using large datasets preferred. Healthcare experience related to cardiovascular disease processes.</li><li>
Years of Experience: 5+ years</li></ul></div><p></p><p><b><br>
ProMedica</b> is a mission-driven, not-for-profit health care organization headquartered in Toledo, Ohio. It serves communities across nine states and provides a range of services, including acute and ambulatory care, a dental plan, and academic business lines. ProMedica owns and operates 10 hospitals and has an affiliated interest in one additional hospital. The organization employs over 1,300 health care providers through ProMedica Physicians and has more than 2,300 physicians and advanced practice providers with privileges. Committed to its mission of improving health and well-being, ProMedica has received national recognition for its clinical excellence and its initiatives to address social determinants of health. For more information about ProMedica, please visit promedica.org/aboutus.</p><p></p><p><b>
Benefits:</b></p><p></p><p>
We provide flexible benefits that include compensation and programs to help you take care of your family, your finances and your personal well-being. It&rsquo;s what makes us one of the best places to work, and helps our employees live and work to their fullest potential.</p><p></p><p>
Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact <b>employment@promedica.org</b></p><p><br>
Equal Opportunity Employer/Drug-Free Workplace</p></div>

Clinical Research Scientist

Beacon Clinic

<div><p>Why Join Us?</p><p></p><p>
Beacon Clinic was founded for the purpose of delivering a level of care that we, as a team, can all be proud of. We are a patient-focused health and wellness clinic that is committed to providing the highest quality of medical care and supportive services. When founded, we specialized in the treatment of cancer and blood conditions. Today, we provide medical oncology and hematology, radiation oncology, rheumatology, and urology services to our phenomenal patients. Learn more about us at our website.</p><p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Job Description:</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div><p>
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI) and VP of Clinical Operations on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.</p></div><p></p><div><p><br>
The CRC works collaboratively with the entire Beacon Clinic team, sponsors, and sponsor monitors to ensure compliance with the protocol, ensuring participant is receiving quality and safe care, along with productive and timely data submissions.</p></div><p></p><p><b>
Duties/Responsibilities:</b></p><ul><li><p>
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) by way of reviewing and acknowledging all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities while utilizing good clinical practice.
</p></li></ul><p></p><ul><li><p>Coordinates participant care throughout the research protocol continuum to include, but not limited to prescreening and screening for eligibility, confirming eligibility prior to randomization, consenting, coordination of all necessary protocol procedures and seeking problem resolutions as necessary.</p></li></ul><p></p><ul><li><p>
Develops and implements accurate source materials and ensures compliance from all applicable site staff.</p></li></ul><p></p><ul><li><p>
Provides accurate and timely data collection documentation, data entry, and reporting in both Beacon&rsquo;s EMR and sponsors applicable databases.</p></li></ul><p></p><ul><li><p>
Reports serious adverse events within 24 hours from site awareness of the event in the applicable data system.</p></li></ul><p></p><ul><li><p>
Confirms appropriate credentialing and trainings are complete and current for accurate data capture regarding all study materials such as protocols, participants questionnaires, electronica data capture systems, collection, storage and shipment of specimens, and drug accountability per delegation of responsibility log.</p></li></ul><p></p><ul><li><p>
Supports the regulatory staff in the maintenance of regulatory documents, standard operating procedures, and applicable regulations.</p></li></ul><p></p><ul><li><p>
Communicates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.</p></li></ul><p></p><ul><li><p>
Participates with principal investigator and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.</p></li></ul><p></p><ul><li><p>
Monitors research participants to ensure visits are appropriately scheduled and include all necessary components.</p></li></ul><p></p><ul><li><p>
Updates research calendar and date spreadsheet to ensure it can be used as an accurate communication tool amongst the research team as well as advising when assistance is needed to meet deadlines per contract, compliance, and sponsors/CRO/monitors requests.</p></li></ul><p></p><ul><li><p>
Carries out daily operations that contribute to the success of Beacon&rsquo;s mission to provide an unparalleled patient experience.</p></li></ul><p></p><ul><li><p>
Performs Medical Assistant duties as needed, including, rooming patients and preparing them for study visits, obtaining and documenting vital signs, height, weight, and medical history updates, assisting providers with exams and procedures per protocol and clinic standards, performing phlebotomy, specimen collection, processing, storage, and shipment per protocol requirements, administering medications and/or injections as delegated and permitted by scope and protocol.</p></li></ul><p></p><p><b>
Required Skills/Abilities:</b></p><div><ul><li><p>
Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts.</p></li></ul></div><div><ul><li><p>
Detail-oriented and meticulous in all aspects of work with the ability to be flexible, organized, detail-oriented and tenacious in follow-through.</p></li></ul></div><p></p><div><ul><li><p>
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.</p></li></ul></div><p></p><div><ul><li><p>
Must have professional demeanor and strong communication skills with the public as well as physicians and researchers.</p></li></ul></div><p></p><div><ul><li><p>
Ability to work well independently as well as in a team environment.</p></li></ul></div><p></p><div><ul><li><p>
Must be proficient in Microsoft Office, electronic health systems and databases used in a research environment or have a willingness to learn and demonstrate proficiency within six months of hire.</p></li></ul></div><p></p><div><ul><li><p>
Possess the ability to work well under pressure, multi-task and manage deadlines.</p></li></ul></div><p></p><div><p><b>
Preferred Qualifications:</b></p></div><div><ul><li><p>
Certification as a Medical Assistant (CMA, RMA, or equivalent) preferred</p></li></ul></div><div><ul><li><p>
Experience in clinical research or healthcare setting preferred</p></li></ul></div><div><ul><li><p>
Phlebotomy experience required or strongly preferred</p></li></ul></div><div><ul><li><p>
Knowledge of Good Clinical Practice (GCP) guidelines</p></li></ul></div><div><ul><li><p>
Strong organizational, communication, and patient care skills</p></li></ul></div><p></p><p><b>
Location:</b></p><ul><li><p>
May be asked to work at both locations</p></li><li><p>
3815 N Schreiber Way, Suite 101, Coeur d'Alene, ID 83815</p></li><li><p>
1641 E Polston Avenue, Suite 102, Post Falls, ID 83854</p></li></ul><p></p><p><b>
Benefits:</b></p><ul><li><p>
Generous Paid Time Off</p></li><li><p>
8 paid, closed-clinic holidays</p></li><li><p>
Health Insurance, including dental and vision</p></li><li><p>
401(k) Plan</p></li><li><p>
Gym membership</p></li><li><p>
Professional Development Fund</p></li></ul><p></p><p><b>
Beacon Company Mission:</b> To meet patients wherever they are on their cancer journey and walk with them on that journey; to provide compassionate, personalized cancer care for an unparalleled patient experience.</p><p></p><p><b>
Beacon Core Values: </b>Compassion. Grace. Honesty. Humor. Respect. Trust.</p><p></p><p>
Our providers and staff at Beacon share these values and truly embody the mission of Beacon. Our team is comprised of the most devoted, compassionate individuals who consistently go above and beyond for patients and who strive to continually improve patient care and the overall patient experience.</p></div>

Clinical Research Coordinator

The IMA Group

<div>
 <p>
  <strong>
   Clinical Research Coordinator
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Chicago, IL | Full-Time | $60,000 - $65,000 annually depending on experience
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  IMA Clinical Research is seeking an experienced
  <strong>
   Clinical Research Coordinator
  </strong>
  for a new role in Chicago. Ideal candidates will have strong clinical trial coordination experience,
  <strong>
   phlebotomy proficiency
  </strong>
  , and exposure to
  <strong>
   CNS, psychiatry, psychology, or social work&ndash;related studies
  </strong>
  .
 </p>
 <p>
 </p>
 <p>
  <strong>
   Responsibilities include:
  </strong>
 </p>
 <ul>
  <li>
   Coordinate clinical trials per protocol and SOPs
  </li>
  <li>
   Communicate with sponsors, CROs, CRAs, IRBs, and site staff
  </li>
  <li>
   Support investigators and ensure accurate documentation (ALCOA)
  </li>
  <li>
   Report adverse events and maintain study data integrity
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications:
  </strong>
 </p>
 <ul>
  <li>
   2+ years of clinical research experience with phlebotomy
  </li>
  <li>
   Bachelor&rsquo;s degree required (Master&rsquo;s preferred)
  </li>
  <li>
   Ability to manage multiple studies independently
  </li>
  <li>
   CNS or behavioral health research experience required
  </li>
  <li>
   CCRC certification a plus
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Benefits:
  </strong>
 </p>
 <ul>
  <li>
   Medical, dental, vision insurance
  </li>
  <li>
   PTO, holidays, and floating holiday
  </li>
  <li>
   401(k) with employer match
  </li>
  <li>
   Tuition reimbursement &amp; student loan repayment assistance
  </li>
  <li>
   Paid parental leave
  </li>
  <li>
   No on-call responsibilities
  </li>
 </ul>
 <p>
 </p>
 <p>
  <strong>
   <em>
    The IMA Group is an Affirmative Action/Equal Opportunity Employer
   </em>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
 </p>
</div>


Clinical Research Coordinator- Chicago, IL

OC PAin and Wellness

<p>Responsibilities:</p><p>- Coordinate clinical research studies from start to finish</p><p>- Recruit and screen potential participants for eligibility</p><p>- Obtain informed consent from participants and ensure compliance with ethical standards</p><p>- Collect and analyze data, including blood samples, using appropriate clinical laboratory techniques</p><p>- Monitor participants' progress throughout the study and address any concerns or adverse events</p><p>- Collaborate with healthcare professionals, including nurses and physicians, to ensure proper care and treatment of participants</p><p>- Maintain accurate and up-to-date documentation of study activities and participant records</p><p>- Adhere to regulatory standards and guidelines for clinical research, including Good Clinical Practice (GCP) standards</p><p>Skills:</p><p>- Strong knowledge of clinical research principles, practices, and regulations</p><p>- Proficiency in statistical software for data analysis</p><p>- Experience in clinical development and conducting clinical trials</p><p>- Ability to perform blood sampling and other clinical procedures as required</p><p>- Excellent organizational skills with attention to detail</p><p>- Strong analytical skills to research, analyze, and interpret complex data sets</p><p>- Effective communication skills to collaborate with multidisciplinary teams and communicate study findings</p><p>Please note that this job description is not exhaustive and additional responsibilities may be assigned as needed.</p><p>Job Type: Full-time</p><p>Pay: $23.00 - $25.00 per hour</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Location:</p><ul><li>Newport Beach, CA 92660 (Required)</li></ul><p>Ability to Relocate:</p><ul><li>Newport Beach, CA 92660: Relocate before starting work (Required)</li></ul><p>Work Location: In person</p>

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>

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