study coordinator

Ray-CRO

<p>Clinical Study Coordinators are tasked with administering clinical trials. Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.</p><p>KEY RESPONSIBILITIES AND TASKS</p><p>&middot; Adhere to Good Clinical Practices and the study protocols</p><p>&middot; Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials</p><p>&middot; Provide patient with written communication of their participation (i.e. copy of the signed informed consent)</p><p>&middot; Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study</p><p>&middot; Schedule all patient research visits and procedures consistent with protocol requirements</p><p>&middot; Complete and maintain case report forms, and review them against the patient&rsquo;s medical record for completeness and accuracy</p><p>&middot; Administer questionnaires/diaries/other patient material per protocol</p><p>&middot; Ensure that non-serious and serious adverse events are properly documented and reported</p><p>&middot; Manage communication with study vendors as needed</p><p>&middot; Ensure the filing and maintenance of all study documents</p><p>&middot; Schedule monitor visits and set up for monitoring visits prior to monitor&rsquo;s arrival</p><p>&middot; Act as a liaison between site staff and different departments</p><p>&middot; Saudi residency is required</p><p>. Minimum Experience 1 year .</p><p>Job Type:</p><p>Full-time</p><p>Job Type: Full-time</p><p>Job Type: Full-time</p>

Clinical Study Coordinator

University Of Washington

<div><p><b>Job Description
</b></p><p></p><div><p>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.<br>
</p></div><p></p><div><p>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.<br>
</p></div><p></p><div><p><b>The </b><b>Division of Gerontology and Geriatric Medicine at Harborview Medical Center </b><b>has an outstanding opportunity for a </b><b>Research Coordinator </b><b>to join their team.
</b></p></div><p></p><p>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.
</p><p></p><p>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.
</p><p></p><p>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.
</p><p></p><p><b>Position Complexities:
</b></p><p>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.
</p><p></p><p><b>Position Dimensions and Impact to the University:
</b></p><p>This position supports and leads research, contributing to the UW&rsquo;s reputation as a research leader.
</p><p></p><p>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.
</p><p></p><p><b>DUTIES AND RESPONSIBILITIES<br>
</b></p><p></p><p><b><i>Regulatory Affairs and Study Development (50%)
</i></b></p><p>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.
</p><p></p><p>&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.
</p><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><p></p><p><b><i>Study Conduct (40%)
</i></b></p><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><p></p><p><b><i>Other Special Projects &amp; Training/Supervision As Needed (10%)
</i></b></p><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><p></p><p><b>MINIMUM REQUIREMENTS
</b></p><ul><li>Bachelor&rsquo;s degree in Health Sciences or related field and one year of relevant experience.
</li></ul><p><i>Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
</i></p><p></p><p><b>ADDITIONAL REQUIREMENTS
</b></p><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><p></p><p><b>DESIRED QUALIFICATIONS
</b></p><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><p></p><p><b>WORKING CONDITIONS
</b></p><p>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.
</p><p></p><p>#UWDeptMedicineJobs
</p><p></p><p><b>Compensation, Benefits and Position Details
</b></p><p></p><p><b>Pay Range Minimum:
</b></p>$60,000.00 annual
<p><b>Pay Range Maximum:
</b></p>$69,600.00 annual
<p><b>Other Compensation:
</b></p><ul><li></li></ul><p><b>Benefits:
</b></p>For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
<p><b>Shift:
</b></p>First Shift (United States of America)
<p><b>Temporary or Regular?
</b></p>This is a regular position
<p><b>FTE (Full-Time Equivalent):
</b></p>100.00%
<p><b>Union/Bargaining Unit:
</b></p>UAW Research
<p></p><p><b>About the UW
</b></p><p></p><p>Working at the University of Washington provides a unique opportunity to change lives &ndash; on our campuses, in our state and around the world.
</p><p></p><p>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.
</p><p></p><p><b>Our Commitment
</b></p><p></p><p>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.
</p><p></p><p>To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu .
</p><p></p><p>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 .</p></div>

Research Coordinator

Mass General Brigham

<div>Site: The Brigham and Women's Hospital, Inc.<br>
<p></p><br>
<p>Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.<br>
</p><p></p><br>
<br>
<p><b>Job Summary
</b></p>GENERAL SUMMARY:
<br>
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The Heart Failure Program at the Mass General Brigham Heart and Vascular Institute is seeking a highly motivated Research Coordinator to join a multidisciplinary team developing and testing artificial intelligence (AI) approaches to improve care for patients with heart failure.
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Working under the supervision of physician-scientists and data scientists, the coordinator will support clinical studies at the intersection of cardiology, data science, and digital health. This includes recruiting with patients, organizing study data, coordinating study visits, and helping ensure the smooth day-to-day operations of ongoing research projects.
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This role offers an exceptional opportunity to gain first-hand experience in AI-enabled clinical research within the Mass General Brigham system&mdash;one of the nation&rsquo;s leading academic medical centers. Coordinators will learn how AI models are developed, validated, and implemented in real-world hospital settings, while working directly with clinicians, research fellows, and engineers.
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Team members are encouraged to participate actively in study meetings, quality improvement efforts, and manuscript or abstract preparation. The position provides excellent preparation for medical school, graduate study in public health or biomedical data science, or careers in clinical research and healthcare innovation.<br>
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PRINCIPAL DUTIES AND RESPONSIBILITIES:
<br>
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1. Provides assistance on clinical and translational research studies according to established study protocols and institutional guidelines.
<br>
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2. Recruits and screens potential participants for studies, including reviewing eligibility criteria, conducting telephone prescreens, and coordinating study visits.
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3. Interacts directly with study participants regarding study procedures, follow-up visits, and data collection; serves as a liaison between patients and clinical/research staff.
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4. Collects and maintains accurate study data, including entry into secure databases and maintenance of source documentation.
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5. Schedules and tracks study visits, patient follow-up calls, and other study-related tasks.
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6. Assists with regulatory and documentation requirements, including IRB submissions, consent forms, and protocol adherence.
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7. Prepares and distributes study materials or mailings to participants as needed.
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8. Communicates with team members, clinical staff, and collaborators to ensure smooth study operations.
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9. Maintains inventory of study supplies
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10. Performs other duties as assigned to support the mission of the research program.<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Qualifications
</b></p></div></div></div></div></div></div></div><h1 class="jobSectionHeader"><b>QUALIFICATIONS:
</b></h1><ul><li>Bachelor&rsquo;s degree (BS or BA)
</li><li>Prior experience in clinical research, healthcare, or a related field preferred but not required
</li></ul><p></p><h1 class="jobSectionHeader"><b>SKILLS/ABILITIES/COMPETENCIES </b><b>REQUIRED:
</b></h1><p></p><ul><li>Excellent interpersonal skills for working with patients and clinical staff.
</li><li>Strong organizational and time management skills; ability to handle multiple tasks simultaneously.
</li><li>Careful attention to detail and data accuracy.
</li><li>Excellent oral and written communication skills.
</li><li>Proficiency with common computer applications (e.g., Microsoft Office, REDCap, or similar databases).
</li><li>Ability to demonstrate professionalism, confidentiality, and respect for patient rights and individual needs.
</li><li>Demonstrated curiosity about medicine, technology, or health innovation.
</li>Ability to work both independently and collaboratively in a fast-moving, multidisciplinary team.<br>
<li>
</li></ul><p></p><br>
<div><div><div><div><div><div><div><p><b>Additional Job Details (if applicable)<br>
</b></p></div></div></div></div></div></div></div><p></p><br>
<div><div><div><div><div><div><div><p><b>Remote Type
</b></p></div></div></div></div></div></div></div>Hybrid<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Location
</b></p></div></div></div></div></div></div></div>75 Francis Street<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Scheduled Weekly Hours
</b></p></div></div></div></div></div></div></div>40<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Employee Type
</b></p></div></div></div></div></div></div></div>Regular<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>Work Shift
</b></p></div></div></div></div></div></div></div>Day (United States of America)<br>
<p></p><br>
<br>
<p><b>Pay Range
</b></p>$19.76 - $28.44/Hourly<br>
<p></p><br>
<p><b>Grade
</b></p>5<br>
<p></p><br>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<br>
<p></p><br>
<div><div><div><div><div><div><div><p><b>EEO Statement:
</b></p></div></div></div></div></div></div></div>The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<br>
<p></p><br>
<h2 class="jobSectionHeader"><b>Mass General Brigham Competency Framework
</b></h2><div><div><p>At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Clinical Research Coordinator Cardiology & AI

ALLERGY, ASTHMA, ASSOCIATES, PC

<p><b>Job Summary</b><br/>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.</p><p><b>Responsibilities</b></p><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><p><b>Skills</b></p><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><p>Job Type: Part-time</p><p>Work Location: In person</p>

Clinical Research Coordinator

City of Hope

<div><div><div><div><div><div><div><div><div><b>Clinical Study Coordinator - Clinical Research (On-Site)-Long Beach Elm</b></div><div>
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope&rsquo;s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.</div><div>
Orange County Medical Center seeks a full-time, on-site Clinical Study Coordinator to support oncology clinical trials. Under the supervision of the Director, Clinical Research, this patient-facing role involves coordinating First in Human to Phase III and Investigator-Initiated Trials. Responsibilities include patient recruitment, informed consent, trial coordination, data management, and regulatory compliance. The position requires in-depth knowledge of clinical trial regulations, strong organizational skills, and the ability to collaborate with investigators and clinical staff in a fast-paced environment.</div><div><b>
As a successful candidate, you will:</b></div><ul><li>
Understand and apply federal regulations (FDA, OHRP, GCP/ICH, HIPAA) and institutional policies.</li><li>
Follow and execute clinical trial protocols and procedures.</li><li>
Coordinate participant recruitment, informed consent, and care.</li><li>
Communicate with participants, investigators, and sponsors to ensure clear understanding and compliance.</li><li>
Monitor and document participant eligibility, safety, and protocol adherence, and report adverse events promptly.</li><li>
Pursue continuous education and training opportunities, staying updated with the latest clinical research information, and maintain necessary certifications and licensure.</li></ul></div></div></div><div><div><div>
Qualifications - External</div></div></div></div></div></div><div><div><div>
Qualifications - External</div></div></div></div><div></div><div><p><b>
Your qualifications should include:</b></p><ul><li>
Bachelor&rsquo;s degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.</li><li>
Minimum of 2 years research or relevant clinical experience</li><li>
ACRP or SOCRA certification within 1 year of employment</li><li>
International Air Transport Association (IATA) within 1 month of employment</li><li>
Good Clinical Practice (GCP) within 1 month of employment</li><li>
Human Subjects Protection (HSP) within 1 month of employment</li><li>
Basic Life Support (BLS) within 1 month of employment</li></ul><p><b>
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.</b></p><p><b>
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please </b><b>click here</b><b>.</b></p><p><b>
To learn more about our Comprehensive Benefits, please</b><b> </b><b>CLICK HERE</b><b>.</b></p></div></div>

Clinical Study Coord

Alcanza Clinical Research

<div><h3 class="jobSectionHeader"><b>Description</b></h3><div><br>
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.<br>
<br>
The <b>Clinical Research Coordinator (CRC)</b> works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.</div><h3 class="jobSectionHeader"><b><br>
Key Responsibilities</b></h3><div><br>
<b>
Essential Job Duties: </b>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><br>
<h3 class="jobSectionHeader"><b>
Skills, Knowledge and Expertise</b></h3><div><br>
<b>
Minimum Qualifications</b>: 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.
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<b>Required Skills:</b>
</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><br>
<h3 class="jobSectionHeader"><b>
Benefits</b></h3><br>
<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><br>
<h3 class="jobSectionHeader"><b>
About Alcanza Clinical Research</b></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.
<br>
<br>
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.
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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.
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<b>Alcanza Clinical Research is an Equal Opportunity Employer</b> 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>

Fenway Health

<div>Description:<p></p><b><br>
Work Location</b>: Hybrid (remote and in-person work expected in Boston, MA area)<b>Expected Schedule</b>: 15 hours a week within a usual Monday-Friday, first shift schedule. May require occasional flexible working schedule with some evening and weekend hours.<p><b>
Function</b></p><p>
This position sits within The Fenway Institute (TFI), the research, education, and policy department of Fenway Health. Reporting to the Assoc. Director of Research Operations and under the supervision of the Principal Investigator, and other TFI Leadership, the Research Associate supports the implementation of research studies.</p><p><b>
Position Funding</b></p><p>
This position is grant-funded and is dependent on the availability of continued grant support for the assigned study/studies. It is possible that the employees&rsquo; effort will be transitioned, in whole or in part, to other research studies as needed.</p><p><b>
Representative Duties</b></p><p><b>
Study Preparation and Administrative/Outreach Implementation</b></p><ul><li><b>
Assist with study startup</b>: Help prepare study documents (e.g., protocols, consent forms, case report forms, participant files, regulatory binders, and visit checklists).</li><li><b>
Regulatory compliance</b>: Ensure studies meet regulatory requirements (e.g., IRB submissions, informed consent documentation).</li><li><b>
Participant recruitment</b>: Implement study recruitment efforts that lead to study participation, with responsibilities such as reviewing records, identifying and establishing recruitment opportunities and initiating outreach to prospective research participants, attending community events; creating recruitment materials; and maintaining recruitment and screening calendars, databases, and study documentation.</li></ul><p><b>
Participant Interaction and Data Collection</b></p><ul><li><b>
Obtain informed consent</b>: Explain study procedures and risks/benefits to participants.</li><li><b>
Conduct study visits</b>: Schedule study visits and maintain study calendar/visit spreadsheets. Confirm participant eligibility and assist with or perform tasks like administering surveys, scheduling follow-ups, and accurately and comprehensively completing visit notes, data collection instruments, case report forms, etc.</li><li><b>
Monitor participant safety</b>: Report non-compliance, adverse events, or unanticipated problems promptly to the research leads.</li></ul><p><b>
Data Management and Documentation</b></p><ul><li><b>
Maintain accurate records:</b> Ensure timely and accurate entry of data into study files, including paper files and electronic databases (e.g., REDCap, EDC systems), and keep organized and complete source document files, including signed consent forms, case report forms, and lab reports.</li><li><b>
Assist in data cleaning and audit preparation:</b> Monitor the quality of collected data through routine and ad hoc quality assurance and quality improvement activities (e.g., record review, monitor visit preparation, completion of visit checklists) and respond to data queries.</li><li><b>
Use best research practices</b>, as defined by Good Clinical Practice (GCP), TFI standard operating procedures, study specific procedures, and the research protocol and follow all established guidelines of confidentiality and ethical accountability.</li></ul><p><b>
Communication and Collaboration</b></p><ul><li><b>
Liaise with internal and external teams</b>: Communicate with investigators, sponsors, IRBs, and study monitors. Share study information to Fenway Health staff, patients, and community.</li><li><b>
Attend team and departmental meetings</b>: Provide updates and help resolve logistical or compliance issues.</li><li><b>
Support training and onboarding</b>: Help train new research assistants or interns on study protocols and procedures</li></ul><p><b>
Administrative and Logistical Support</b></p><ul><li><b>
Manage supplies and equipment</b>: Track, maintain, and order study-specific materials.</li><li><b>
Schedule appointments and organize calendars</b>: Coordinate participant visits and team availability.</li><li><b>
Assist with study closeout</b>: Ensure all documents are archived according to protocol and regulatory guidelines.</li><li><b>
Assist in the development of research projects and publication/dissemination of study findings: </b>Utilize library and electronic databases to locate and obtain research articles and performs administrative duties, as needed, in the development of research proposals or manuscripts.</li><li><b>
Develop and share understanding of research context: </b>Monitor and track institutional, state level and federal level policies impacting participant population and research; develop knowledge of field by completing pertinent trainings, attending didactics, reading academic journals, articles and other relevant publications, attending conferences, seminars, forums, trainings and other presentations.</li></ul><p><b>
Other related duties as required.</b></p><p><b>
Meets Agency Participatory Expectations</b></p><ul><li>
Adheres to all agency and departmental policies and procedures</li><li>
Identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation</li><li>
Attends all required meetings, in-services and professional trainings</li><li>
Maintains professional competence necessary to perform job responsibilities; maintains and provides agency with records of continuing education activities</li><li>
Serves on agency committees and in professional organizations when requested</li><li>
Work harmoniously and effectively with colleagues, patients, clients and vendors across the spectrum of diversity, including but not limited to race, ethnicity, color, gender identity, sexual orientation, age, socio-economic status, national origin and immigrant status, religious or spiritual identity, disability (physical, mental, emotional and developmental), veteran status, and/or limited English proficiency.</li></ul>
Requirements:
<ul><li>Bachelor&rsquo;s degree or higher in field related to social science research.</li><li>
Excellent communication (written and verbal) skills and experience working with diverse communities at risk for HIV infection, particularly sexual minority men, transgender individuals, and BIPOC individuals.</li><li>
Ability to work harmoniously and effectively with colleagues, patients, clients and vendors across the spectrum of diversity, including but not limited to race, ethnicity, color, gender identity, sexual orientation, age, socio-economic status, national origin and immigrant status, religious or spiritual identity, disability (physical, mental, emotional and developmental), veteran status, and/or limited English proficiency.</li><li>
Willingness to contribute towards Fenway&rsquo;s efforts in becoming an anti-racist organization and promoting a culture dedicated to ongoing development in service of humility, equity, diversity, inclusion, and belonging, where differences are acknowledged and valued.</li></ul><p><b>
Preferred Qualifications</b></p><ul><li>
Demonstrated ability to take responsibility for assignments and deadlines and to work as part of a team</li><li>
1-2 years human subjects research experience</li><li>
Detail-oriented</li><li>
Computer (Microsoft Word, Power-Point, Email) Skills</li><li>
Familiarity with database software (SPSS, Microsoft Excel)</li></ul><b>
 This is a union position in a Fenway Health bargaining unit represented by 1199 SEIU United Healthcare Workers East.</b><br>
We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 11 paid holidays, paid vacation, and more.<b>LGBTQIA+ identified persons, Black, Indigenous, and other people of color (BIPOC), and individuals from other historically underrepresented communities are strongly encouraged to apply.</b></div>

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