research coordinator

University Of Washington

<div>Job Description
<div>As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world. 
</div><div>UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty. 
</div><div>The Division of Gerontology and Geriatric Medicine at Harborview Medical Center has an outstanding opportunity for a Research Coordinator to join their team.
</div>The Division of Gerontology and Geriatric Medicine at Harborview Medical Center has an opportunity for a Research Coordinator to lead and manage clinical trials and studies focused on Alzheimer's Disease and related dementias. Working with the Principal Investigator, the Research Coordinator will be responsible for implementing clinical interventional trials within vulnerable patient populations. These clinical research studies are conducted in older adults to investigate how the brain responds to acute meal and nutrient interventions, and to assist with clinical trials involving diabetes medications and cognitive interventions including crossword puzzles.
The Research Coordinator will employ established best practices to ensure that all research meets or exceeds requirements while maintaining appropriate patient confidentiality and furthering the research objectives of the Hanson Laboratory. This position will be responsible for orienting and educating faculty investigators, staff at collaborating enrollment sites, and Alzheimer&rsquo;s Disease Research Center staff to clinical protocols and expectations. The Research Coordinator will identify, recruit, and consent clinical research subjects with varying levels of cognitive ability as well as their family members and caregivers. The Research Coordinator will use independent judgment, problem-solving skills, and project management skills to ensure that each of the research projects meets established benchmarked deliverables. Finally, the Research Coordinator will assist the PI in training and supervising study staff and work-study students and run weekly lab meetings. To support this endeavor, the Alzheimer&rsquo;s Disease Research Center provides workshops for senior Coordinators who will conduct talks and mentor new Coordinators on topics such as informed consent, trial design, etc.
Research Study Coordinator training is required because this position will work with protected health data and human subjects within UW Medicine. The training requirement for this position includes UW Medicine-specific and general training such as Good Clinical Practice, HIPPA, biosafety, etc., and will be provided during position onboarding.
Position Complexities:
This position requires independent judgment, leadership, and expert knowledge of clinical research and regulatory operations to effectively facilitate study workflow on behalf of the Principal Investigator. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, federal agencies, and industry partners. This position is required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University and federal regulatory agencies. Additionally, the RC will coordinate multiple data collection efforts which will include other collaborating agencies and institutions nationally, including the NIH. The RC will recruit human subjects, write and edit reports, develop and monitor reports, work with funding agencies, and train/direct the work of assigned staff in related areas.
Position Dimensions and Impact to the University:
This position supports and leads research, contributing to the UW&rsquo;s reputation as a research leader.
This is a 1.0 Research Coordinator position in a research group focusing on Alzheimer's Disease and related dementia. The Hanson research group is funded by both federal and non-federal funding sources and has 4-6 interventions occurring concurrently.
DUTIES AND RESPONSIBILITIES 
Regulatory Affairs and Study Development (50%)
This position has the overall responsibility for ensuring that the Alzheimer&rsquo;s Research Program clinical trials meet regulatory requirements and are compliant with federal and institutional policies. This will necessitate research protocol submissions to various institutional and external IRBs, ongoing tracking of annual IRB renewals, submission of annual reviews, modifications to existing protocols, SAEs, and protocol deviations to the appropriate IRB. This position must be able to work with minimal supervision on multiple research projects. This position supervises and works closely with the other RCs on the Alzheimer's Disease studies and requires daily interaction with physicians/PIs, research staff at collaborating institutions, pharmaceutical company sponsors, and any other groups integral to the successful completion of research projects.
&bull; Oversee regulatory affairs coordination as outlined by protocol objectives. This includes becoming familiar with the active Alzheimer&rsquo;s clinical trials and submitting IRB applications and modifications in a timely fashion.&bull; Write/edit clinical research consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate &ldquo;Elements of Informed Consent.&rdquo; Translate complicated research protocol requirements into language easily understandable by research participants.
<ul><li>Assist faculty in writing Investigational New Drug applications and annual reports for investigator-initiated clinical trials. Coordinate initial and ongoing submissions, and annual reports to the Food and Drug Administration.
</li></ul><ul><li>Maintain and update all required regulatory documents (FDA Form 1572 and/or 1571, Protocol Signature Page, Investigator Brochure, Financial Disclosure, laboratory accreditations, laboratory reference ranges, investigators&rsquo; and research staffs&rsquo; CVs, medical licensures, and related forms per sponsor or federal requirements)
</li></ul><ul><li>Assist in the development of protocols for therapeutic clinic trials as well as minimal risk research projects and chart reviews.
</li></ul><ul><li>Conduct Quality Assurance for the Alzheimer&rsquo;s Research Program. Responsible for conducting quality assurance audits of the Alzheimer&rsquo;s Research Program trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source document verification against data capture systems, consent documentation compliance, and AE, SAE and concomitant medication review.
</li></ul><ul><li>Create and maintain written materials in varying media areas, improving external visibility of the research program for the purposes of trial acquisition and subject recruitment.
</li></ul><ul><li>Act as a subject-matter-expert in the development and implementation of the use of &quot;plain language&quot; for writing subject-facing materials. Mentor other research staff in the use of plain language.
</li></ul><ul><li>Involve Alzheimer&rsquo;s Research Team Management and Leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation; use problem-solving and interpersonal skills with organized process improvement efforts.
</li></ul><ul><li>Summarize study results, and prepare reports, perform data validations and accuracy of study information housed in RedCap, OnCore and other UW systems.
</li></ul><ul><li>Facilitate sponsor status updates using established milestone reporting deadlines, such as interim reports for the NIH or industry sponsors.
</li></ul>Study Conduct (40%)
<ul><li>Using appropriate inclusion and exclusion criteria, the research coordinator will confirm eligibility and conduct this process with the discretion necessary for interactions with vulnerable patient populations.
</li></ul><ul><li>The Research Coordinator will independently perform a variety of assessments including cognitive testing and scoring for multiple participant visits, and complete all study-related forms, including consent, data collection and validation.
</li></ul><ul><li>The research coordinator is responsible for recruiting, scheduling, identifying, and consenting study subjects for multiple, concurrent research studies, through the use of research registries, electronic health record systems, and other recruitment tools.
</li></ul><ul><li>Produce written communications pertaining to study content. Prepare and track study follow-up activities to ensure subsequent study participation timelines and requirements are met.
</li></ul><ul><li>Directly respond to study content queries from participants, family members, collaborating providers and staff.
</li></ul><ul><li>The research coordinator will acquire and retain study data, perform data evaluations and assess data collection activities performed by other members of the study team including but not limited to other research coordinators, graduate and undergraduate trainees.
</li></ul><ul><li>Process human subject specimens including blood and spinal fluid, as well as manage freezer specimens for sample send-outs in accordance with federal and institutional biologic shipping regulations.
</li></ul><ul><li>Assist collaborators at the Alzheimer&rsquo;s Disease Research Center (ADRC) with additional study procedures and conduct, as needed and with the approval and oversight of the PI.
</li></ul><ul><li>Manage study materials ordering and inventory.
</li></ul><ul><li>The research coordinator will be responsible for meeting enrollment milestones, ensuring that projects are executed successfully and completed within needed timeframes to meet research objectives.
</li></ul><ul><li>The research coordinator is responsible for advising investigators of identified enrollment barriers and devising protocol revisions that will address these identified barriers.
</li></ul><ul><li>The research coordinator will provide cross coverage support for the other research coordinator and research study coordinators.
</li></ul>Other Special Projects &amp; Training/Supervision As Needed (10%)
<ul><li>Supervises, assigns work to and assesses the accuracy of acquired data by undergraduate and graduate student employees.
</li></ul><ul><li>Responsible for orienting new research group members to study protocols and training group members to conduct interventions.
</li></ul><ul><li>Assist the PI with the supervision of work-study students and volunteers on the studies.
</li></ul>MINIMUM REQUIREMENTS
<ul><li>Bachelor&rsquo;s degree in Health Sciences or related field and one year of relevant experience.
</li></ul>Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
ADDITIONAL REQUIREMENTS
<ul><li>Candidates will be required to complete blood-borne pathogens training, CITI research ethics training (Good Clinical Practice) or equivalent, UW lab safety training, and HIPAA training .
</li></ul>DESIRED QUALIFICATIONS
<ul><li>Familiarity with RedCAP.
</li></ul><ul><li>Experience with healthcare research and electronic medical records systems.
</li></ul><ul><li>Experience with diverse/vulnerable populations and direct patient/family/caregiver contact for administration of questionnaires.
</li></ul>WORKING CONDITIONS
The study requires travel to UWMC &ndash; Montlake campus, South Lake Union campus, and Harborview Medical Center campus to consent participants and administer surveys and interventions.
#UWDeptMedicineJobs
Compensation, Benefits and Position Details
Pay Range Minimum:
$60,000.00 annual
Pay Range Maximum:
$69,600.00 annual
Other Compensation:
<ul><li></li></ul>Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
UAW Research
About the UW
Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty.
Our Commitment
The University of Washington is proud to be an affirmative action and equal opportunity employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law .</div>

Research Coordinator

Key Clinical Research

Job Summary We are seeking an experienced Clinical Research Coordinator to join our growing research team. The Clinical Research Coordinator plays a pivotal role in the management and execution of clinical trials. This position involves overseeing the day-to-day operations of research studies, managing all aspects of assigned clinical trials in accordance with Good Clinical Practice (GCP), FDA regulations, IRB policies and internal standard operating procedures (SOP's). This role requires a detail-orientated, organized professional that thrives in a fast- paced environment and has strong interpersonal and problem -solving skills.Duties<ul><li>Coordinate and manage all aspects of assigned clinical trials from initiation through close out.</li><li>Ensure adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements.</li><li>Conduct patient recruitment, prescreening, screening, and informed consent processes.</li><li>Serve as the primary liaison between sponsors, CRO's, monitors and internal staff.</li><li>Monitor patient progress throughout the study, documenting any adverse events or changes in condition.</li><li>Collect, record and maintain accurate source documentation and case report forms.</li><li>Prepare for and participate in monitoring visits, audits and inspections</li><li>Maintain comprehensive records of study activities, including medical terminology relevant to the research.</li><li>Collaborate with physicians, nurses, and other healthcare professionals to facilitate effective communication regarding study protocols.</li></ul>Qualifications<ul><li>Bachelor&rsquo;s degree in a relevant field; nursing experience is a plus.</li><li>Strong understanding of clinical development processes and regulatory requirements.</li><li>Proficient in medical terminology and data collection methodologies.</li><li>Ability to perform blood sampling and phlebotomize patients safely and effectively is a plus.</li><li>Ability to manage multiple studies with minimal supervision from leadership.</li><li>Excellent organizational skills with the ability to supervise staff effectively.</li><li>Strong communication skills to interact with patients, healthcare professionals, and research teams.</li><li>Prior experience in a clinical research setting is highly desirable.</li><li>Certified Clinical Research Coordinator (CCRC) preferred.</li></ul>This role is essential for advancing medical knowledge through rigorous research practices while ensuring the safety and well-being of participants involved in clinical trials.Job Type: Full-timePay: $21.89 - $28.77 per hourExpected hours: 40 per weekBenefits:<ul><li>401(k)</li><li>Health insurance</li><li>Paid time off</li></ul>Work Location: In person

Clinical Research Coordinator

Stanford University

Stanford School of Medicine is seeking a Social Science Research Professional 1 to serve as a Research Coordinator who will be an active contributor to a melanoma research projects with important public health impact. Duties may include: meeting planning and support, coordinating research activities with internal and external partners for recruitment, enrollment, data gathering, and administering survey instruments, while exercising independent initiative and judgment. The role requires a high degree of organization, continuous exercise of independent initiative and judgment, strong ethic of collaboration, and exceptional, interpersonal skills. This is an ideal position for an individual with a BA or Master's degree in a relevant field such as public health, health care management, health services research, sociology, or anthropology, interested in advancing toward higher level training, who has a passion for improving health equity in the United States. Duties include: <ul><li> Contribute to the development and administration of survey instruments. </li><li> Meeting planning and support (scheduling, agenda develop, notetaking, and other tasks as necessary) </li><li> Keep track of project plans and budgetary expenditures to help ensure that projects are completed on-time and within budget. </li><li> Schedule research team meetings and update project plans and associated tasks according to meeting discussions and outcomes. </li><li> Draft IRB applications and submit application for approvals for research projects under supervision. </li><li> Draft regulatory and project reports. </li><li> Review and audit case reports to ensure accurate data collection, entry, and compliance with research protocols. </li><li> Assist with building research instruments using standard survey tools such as Redcap, Qualtrics, etc. </li><li> Work with PI and other research staff in the synthesis and interpretation of quantitative and/or qualitative data using appropriate data analysis methods and programs. </li><li> Conduct literature reviews on assigned research topics and summarize results. </li><li> Contribute to data analysis (e.g. quality control, preliminary analysis of quantitative data). </li><li> Update research materials (e.g. recruitment materials, updated surveys) and submit to IRB to maintain IRB approval status of projects. </li><li> Assist with the design of flyers, outreach materials, and educational tools as needed for research activities and dissemination activities. </li><li> Coordinate and contribute to collaborative research activities with community partners, collaborators, and/or students. </li><li> May supervise and support other staff who are engaged in related research studies. - Other duties may also be assigned </li></ul> DESIRED QUALIFICATIONS: <ul><li> Proven track record of taking initiative and problem-solving, successfully juggling and prioritizing multiple projects. </li><li> Experience with standard medical research database and survey programs for data collection such as REDCap, Qualtrics, etc. </li><li> Experience with NVivo or equivalent software (or equivalent software). </li><li> Experience using statistical software such as R or STATA (or equivalent software). </li><li> Experience with collaborative software programs such as Google Drive, Box, Smartsheets, Slack, Zoom, etc. </li><li> Substantial experience with standard software packages including Word, Excel, and PowerPoint. </li><li> Strong skills in developing and maintaining community partnerships that lead to effective research participation. </li><li> Ability to work with diverse populations, including those with limited English proficiency or low literacy levels. </li><li> Prior research experience in social science, public health, or medical research involving human subjects. </li><li> Prior experience in developing literature review or research reports (coursework is fine). </li><li> Professional level fluency in Spanish. </li></ul> EDUCATION & EXPERIENCE (REQUIRED): Bachelor of Arts degree in an applicable social science related field, or combination of education and relevant experience in an applicable social science. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): <ul><li> General understanding of scientific theory and methods typically gained through completion of an undergraduate degree in a related field. </li><li> General computer skills and ability to quickly learn and master computer programs. </li><li> Ability to work under deadlines with general guidance. </li><li> Excellent organizational skills and demonstrated ability to complete detailed work accurately. </li><li> Effective oral and written communication skills. </li><li> Ability to work with human study participants. </li></ul> PHYSICAL REQUIREMENTS : <ul><li> Frequently perform desk-based computer tasks, grasp lightly/fine manipulation, lift/carry/push/pull objects that weigh up to 10 pounds. </li><li> Occasionally stand/walk, sit, use a telephone, writing by hand, and sort/file paperwork or parts. </li><li> Rarely twist/bend/stoop/squat, kneel/crawl, rarely reach/work above shoulders, and operates foot and/or hand controls. </li></ul> - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: <ul><li> May be exposed to blood borne pathogens. </li><li> May be required to work non-standard, extended or weekend hours in support of research work. </li></ul> WORK STANDARDS: <ul><li> Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. </li><li> Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. </li><li> Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, . </li></ul> This role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate. The expected pay range for this position is $24.33 to $33.77 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form . Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. <img src="https://www.jobg8.com/Tracking.aspx?Sjg9ltxO2380pbMPGoNWeMzkvHjNBe%2bRi" width="0" height="0" />

University of Miami

<div><h2 class="jobSectionHeader">Current Employees:
</h2>If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet .
The department of Medicine, division of Infectious Diseases, has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work on the UHealth campus. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation, and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.
CORE JOB FUNCTIONS
<ul><li>Assists in participant recruitment and retention activities, and assists in screening potential study participants for eligibility.
</li><li>Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
</li><li>Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
</li><li>Maintains study binders and filings according to protocol requirements, UM and department policy.
</li><li>Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
</li><li>Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
</li><li>Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
</li><li>Assists with study orientation and protocol related in-services to research team and clinical staff.
</li><li>Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
</li><li>Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators&rsquo; academic administrative personnel, and departments.
</li><li>Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
</li><li>Adheres to cultural competency guidelines; implements strategies to meet study participants&rsquo; needs for language translation, health literacy, etc.
</li><li>Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
</li><li>Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
</li><li>Adheres to University and unit-level policies and procedures and safeguards University assets.
</li></ul>This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
<ul><li>Bachelor&rsquo;s degree in relevant field required
</li><li>Minimum 2 years of relevant experience
</li><li>Bilingual (English/ Spanish) highly preferred
</li></ul>Knowledge, Skills and Attitudes:
<ul><li>Skill in completing assignments accurately and with attention to detail.
</li><li>Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
</li><li>Ability to process and handle confidential information with discretion.
</li><li>Ability to work evenings, nights, and weekends as necessary.
</li><li>Commitment to the University&rsquo;s core values.
</li><li>Ability to work independently and/or in a collaborative environment.
</li></ul>The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A9</div>

Clinical Research Coordinator 2

<div>Stanford University&rsquo;s Department of Neurosurgery is seeking a Clinical Research Coordinator II (CRCII) to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. Studies may include drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric and adult neuro-Oncology treatments. The CRCII will directly coordinate 2 or more clinical studies, supervise and delegate tasks for 5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, federal and grant funded clinical research studies. The CRC II will manage 1-3 CRCAs and will be responsible for training, assigning tasks and reviewing their work. This CRC II position is a full-time position, and a commitment of at least two years is required. CRC IIs are expected to be available up to 5 days a week on site. This position may require occasional evening and weekend hours.
Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter. 
Duties include*:<ul><li>
Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.</li><li>
Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.</li><li>
Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.</li><li>
Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.</li><li>
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.</li><li>
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.</li><li>
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.</li><li>
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.</li><li>
Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.</li><li>
Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.</li><li>
Hybrid Work Agreement.</li><li>Other duties may also be assigned.</li></ul> 
<div>DESIRED QUALIFICATIONS:<ul><li>
Neurosurgery/ Oncology clinical trial coordination experience working with adults and children.</li><li>
Investigator Initiated clinical trial coordination experience.</li><li>
Experience with local and single-IRB submissions.</li><li>
Experience with protocol drafting and IND/IDE documents.</li><li>
Experience working with various databases such as REDCap, Oncore and various EDC systems.</li><li>
Knowledge of data-related research and presentation of research data.</li><li>
Enjoy working directly with patients and their families.</li><li>
Exceptionally organized and can balance multiple projects at once.</li><li>
Have the necessary patience and resourcefulness to interact well with individuals and their families.</li></ul> 
EDUCATION &amp; EXPERIENCE (REQUIRED):
Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):<ul><li>
Strong interpersonal skills, including the ability to work easily with research participants and research team members.</li><li>
Strong general computer skills and ability to quickly learn and master computer programs.</li><li>
Proficiency with Microsoft Office and Adobe.</li><li>
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB submissions.</li><li>
2-4 years clinical research coordinator experience.</li><li>
Knowledge of medical terminology.</li></ul> 
CERTIFICATIONS &amp; LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 
PHYSICAL REQUIREMENTS*:<ul><li>
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.</li><li>
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.</li><li>
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.</li><li>- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.</li></ul> 
WORKING CONDITIONS:<ul><li>
Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.</li><li>
May require extended or unusual work hours based on research requirements and business needs.</li></ul> 
WORK STANDARDS:<ul><li>
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.</li><li>
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.</li><li>
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.</li></ul> 
The expected pay range for this position is $86,248 to $100,158 per annum.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford&rsquo;s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.</div></div>

ALLERGY, ASTHMA, ASSOCIATES, PC

Job Summary We are seeking a highly organized and detail-oriented Clinical Research Coordinator to oversee and manage clinical trials within our research facility. The ideal candidate will play a vital role in coordinating all aspects of clinical studies, ensuring compliance with regulatory standards, and maintaining accurate documentation. This position offers an opportunity to contribute to groundbreaking medical research and improve patient outcomes through meticulous trial management and data collection.Responsibilities<ul><li>Coordinate and oversee clinical trial activities in accordance with FDA regulations, Good Clinical Practice (GCP), and HIPAA guidelines.</li><li>Manage patient recruitment, screening, enrollment, consent, and monitoring throughout the trial process.</li><li>Review and verify documentation, including informed consent forms, case report forms, and other study-related records.</li><li>Collect, record, and manage clinical data accurately using EMR systems and adhere to CDISC standards for data management.</li><li>Conduct patient medical photography and potentially sample handling and storage.</li><li>Ensure compliance with clinical development protocols and regulatory requirements during all phases of trials.</li><li>Analyze collected data using statistical software to support study findings and prepare reports for review.</li><li>Maintain detailed records of study activities, adverse events, and protocol deviations for audit purposes.</li><li>Assist in training new staff on clinical trial procedures and documentation review processes.</li></ul>Skills<ul><li>Proven experience in a clinical research setting is preferred.</li><li>General knowledge of clinical trials management, including FDA regulations, GCP, HIPAA compliance, and CDISC standards.</li><li>Understanding of medical terminology.</li><li>Excellent documentation review skills with attention to detail for accuracy and regulatory compliance.</li><li>Ability to monitor patients effectively while maintaining confidentiality under HIPAA guidelines.</li><li>Strong analytical skills for data collection, analysis, and interpretation within clinical research projects.</li><li>Thorough proficiency in Microsoft suite core productivity tools (e.g. Word, PowerPoint, Excel). Proficiency with EMR systems, data management tools, and statistical software is a plus.</li></ul>Job Type: Part-timeWork Location: In person

Alcanza Clinical Research

<div><h3 class="jobSectionHeader">Description</h3><div> 
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. 
 
The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.</div><h3 class="jobSectionHeader"> 
Key Responsibilities</h3><div> 

Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:</div><ul>
<li>Screening of patients for study enrollment;</li>
<li>Patient consents;</li>
<li>Patient follow-up visits;</li>
<li>Documenting in source clinic charts;</li>
<li>Entering data in EDC and answers queries;</li>
<li>Obtaining vital signs and ECGs;</li>
<li>May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;</li>
<li>Requesting and tracking medical record requests;</li>
<li>Updating and maintaining logs, chart filings;</li>
<li>Maintaining &amp; ordering study specific supplies;]</li>
<li>Scheduling subjects for study visits and conducts appointment reminders;</li>
<li>Building/updating source as needed;</li>
<li>Conducting monitoring visits and resolves issues as needed in a timely manner;</li>
<li>Ensuring study related reports and patient results are reviewed by investigator in a timely manner;</li>
<li>Filing SAE/Deviation reports to Sponsor and IRB as needed;</li>
<li>Documenting and reporting adverse events;</li>
<li>Reporting non-compliance to appropriate staff in timely manner;</li>
<li>Maintaining positive and effective communication with clients and team members;</li>
<li>Always practicing ALCOAC principles with all documentation;</li>
<li>May assist with study recruitment, patient enrollment, and tracking as needed;</li>
<li>Maintaining confidentiality of patients, customers and company information, and;</li>
<li>Performing all other duties as requested or assigned.</li>
<li>Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;</li>
<li>Prepare and attend site initiation visits (SIV&rsquo;s) and Investigator Meetings (IMs), as needed;</li>
<li>May set up, train and maintain all technology needed for studies.</li></ul> 
<h3 class="jobSectionHeader">
Skills, Knowledge and Expertise</h3><div> 

Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate&rsquo;s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.
 
 
Required Skills:
</div><ul><li>Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);</li>
<li>Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc</li>
<li>Strong organizational skills and attention to detail.</li>
<li>Well-developed written and verbal communication skills.</li>
<li>Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.</li>
<li>Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.</li>
<li>Must be professional, respectful of others, self-motivated, and have a strong work ethic.</li>
<li>Must possess a high degree of integrity and dependability.</li>
<li>Ability to work under minimal supervision, identify problems and implement solutions.</li>
<li>Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.</li></ul> 
<h3 class="jobSectionHeader">
Benefits</h3> 
<ul>
<li>
Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.</li>
<li>Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.</li></ul> 
<h3 class="jobSectionHeader">
About Alcanza Clinical Research</h3><div>
Alcanza Clinical Research (&ldquo;Alcanza&rdquo;) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all.
 
 
We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life.
 
 
Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined.
 
 
Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.</div></div>

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