clinical study coordinator

Milestone One

<div>
 <p>
  Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.
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 <strong>
  Job Description
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 </strong>
 <p>
  The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution.  In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.
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 </p>
 <p>
  <strong>
   <u>
    In this job you will:
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   </u>
  </strong>
 </p>
 <ul>
  <li>
   Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
  </li>
  <li>
   Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
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   Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
  </li>
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   Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
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   Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
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   Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment.
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   Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
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   Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
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   Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
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  </li>
 </ul>
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  <li>
   Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
  </li>
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   Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
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   Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
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   Support the contract and budget negotiations and oversees Investigator/Site Payments.
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   Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation.
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   Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
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   Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
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   Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
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   May be involved in the on-site training of additional staff as part of the SEO or other education programs.
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   Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
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   Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
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   SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.
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 <strong>
  Qualifications
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 </strong>
 <p>
  <strong>
   <u>
    Education
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   </u>
  </strong>
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  Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.
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  Nephrology experience preferred.
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 <p>
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    Certifications
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   </u>
  </strong>
 </p>
 <ul>
  <li>
   Current Good Clinical Practice (GCP)
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   International Air Transport Association (IATA)
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   Current Basic Cardiopulmonary Resuscitation (CPR)
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   Phlebotomy certification unless part of active professional licensure (RN or LPN)
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   Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.
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  </li>
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 <strong>
  Additional Information
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  <em>
   Located in South Cook/ Will County, Chicago (On-site position).
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 <p>
  If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!
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</div>


Clinical Study Coordinator

Columbia University

<div><ul><li>Job Type: Officer of Administration</li>
<li>Bargaining Unit:</li>
<li>Regular/Temporary: Regular</li>
<li>End Date if Temporary:</li>
<li>Hours Per Week: 35</li>
<li>Standard Work Schedule:</li>
<li>Building:</li>
<li>Salary Range: $66,300 - $66,300</li>
</ul><div><i>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</i></div><br>
<div></div>
<p>
Position Summary</p>
<p>
The Research Division of the Department of Emergency Medicine is seeking a Clinical Research Coordinator to lead clinical studies being conducted in the Pediatric Emergency Department.</p>
<p>
Reporting to the Research Manager and under supervision of the department&rsquo;s Principal Investigators (PI), the Clinical Research Coordinator will support the department&rsquo;s research portfolio by organizing and conducting all aspects of clinical research projects as a member of the Research Coordinator team. This role will involve a variety of responsibilities, including coordination of patient participation (i.e. recruitment, screening, enrollment, and follow-up), collection and maintenance of study data, management of regulatory materials, and ensuring adherence to study protocol activities in accordance with clinical research principles.</p>
<p></p>
<p>Responsibilities</p>
<ul>
<li><p>General Study Management:</p>
<ul>
<li>Organization of the start-up of studies, including preparation and submission of protocols to the IRB and training of study personnel</li>
<li>Maintenance and organization of project documentation and records, and preparation and submission of protocol renewals</li>
<li>Maintenance of essential documents and regulatory binders</li>
<li>Organization of study meetings and study-related administrative processes</li>
<li>Ensuring compliance with the University's required certifications in Human Research Protection and HIPAA regulations</li>
<li>Communicating with all members of research team, various collaborating departments, and clinical staff to ensure success of studies</li></ul><br>
<p></p>
<p>
Patient Management</p>
<ul>
<li>Patient enrollment, including obtaining informed consent</li>
<li>Working with treating physicians and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols</li>
<li>Conferring with study patients to explain the purpose of the research study and diagnostic procedures</li>
<li>Completion of participant assessments and follow-up surveys as appropriate</li></ul><br>
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<p>
Data Management:</p>
<ul>
<li>Collection of pertinent information and data from subject charts and records, subject interviews, and other sources to meet data entry deadlines as outlined in protocols</li>
<li>Completion of case report forms (CRFs), including review of CRFs to ensure completeness</li></ul><br>
<p></p>
<p>
Other:</p>
<ul>
<li>Performance of Quality Assurance/Quality Control tasks</li>
<li>Some evening and weekend shifts may be required</li>
<li>Other related duties as necessary</li>
<li>Position is supported by grant funding</li>
</ul>
</li></ul><p></p><p>Minimum Qualifications</p>
<p>
Requires a bachelor's degree or equivalent in education and experience</p>
<p></p>
<p>Required Skills/Abilities</p>
<ul>
<li>Strong organizational skills and attention to detail</li>
<li>Excellent written and oral communication skills</li>
<li>Demonstrates good judgement under pressure</li>
<li>Ability and willingness to learn new systems and programs</li>
<li>Ability to undertake multiple tasks simultaneously and prioritize responsibilities</li>
<li>Must be motivated and proactive</li>
<li>Capacity to work both independently and perform as part of a team</li>
<li>Proficient in Microsoft Office and web browser programs</li>
</ul>
<p></p><p>Preferred Qualifications</p>
<ul>
<li>Minimum of two years of related experience in clinical research or a health science discipline, such as biochemistry, anatomy, pathology, nursing, medical technology, public health, or equivalent.</li>
<li>Experience in clinical research setting with knowledge of HIPAA and GCP</li>
<li>Prior involvement in the coordination and implementation of research projects</li>
<li>Experience with IRB</li>
<li>Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, or OpenSpecimen</li>
<li>Fluency in Spanish</li>
</ul>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Research Coordinator - Emergency Medicine

Johns Hopkins University

<p></p><div><p>Researchers at Johns Hopkins University is seeking a <b><i>Sr. Clinical Research Coordinator</i></b> to conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Coordinator oversees the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.</p><p></p><p><b><br>
</b></p><p></p><p><b>Specific Duties &amp; Responsibilities</b></p><ul><li>
Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study design.
</li><li>Develop standard operating procedures and data collection forms from protocol(s).</li><li>
Develop consent form(s) for clinical trials based on protocol(s).
</li><li>Prepare materials for submission to IRB.</li><li>
Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.</li><li>
Ensure compliance with all protocols, procedures, and applicable regulations.
</li><li>Participate in developing the study budget.
</li><li>Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.</li><li>
Set up a data collection system and ensure the validity of study data.
</li><li>Organize and quality control study data.</li><li>
Perform self-audits and/or audit other sites.</li><li>
Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
</li><li>Conduct literature searches to provide background information.
</li><li>Abstract and index information based on knowledge of subject matter.</li><li>
Other duties as assigned.</li></ul><p></p><p><i><br>
In addition to the duties above</i></p><ul><li>
Develop and maintain community relations, including but not limited to relations with primary care providers located in practices around the state of Maryland and professional organizations (e.g., Maryland Chapter of the American Academy of Pediatrics).</li><li>
Represent Maryland Behavioral Health Integration in Pediatric Primary Care (BHIPP) in the public sphere (e.g., conferences, training events).</li><li>
Manage marketing efforts, program e-newsletter, website maintenance, and social media maintenance.</li><li>
Coordinate in-person and web-based training events for providers and technical assistance for primary care practices.</li><li>
Complete and maintain continuing medical education applications and approvals associated with training events.</li></ul><p></p><b><br>
Minimum Qualifications</b><br>
<ul><li>
Bachelor's Degree in a related field.</li><li>
Three years of related experience.</li><li>
Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.</li></ul><br>
<b>
Preferred Qualifications</b><br>
<ul><li>
Master's Degree in a related field.</li><li>
Experience working in community settings, experience working with primary care settings.</li></ul><p></p><p><br>
Classified Title: Sr. Clinical Research Coordinator
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Role/Level/Range: ACRP/03/MB
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Starting Salary Range: $41,300 - $72,300 Annually ($50,000 targeted; Commensurate w/exp.)<br>
Employee group: Full Time<br>
Schedule: M-F 8:30-5pm<br>
FLSA Status: Exempt<br>
Location: Hybrid/School of Medicine Campus<br>
Department name: SOM Psy Child and Adolescent Psychiatry<br>
Personnel area: School of Medicine</p></div><p></p>

Sr. Clinical Research Coordinator (Psychiatry & Behavioral Sciences)

Medix™

<div>
 <p>
  The Clinical Research Coordinator (CRC) is responsible for the daily management and execution of clinical trials at the research site, working under the guidance of the Principal Investigator (PI). The CRC ensures that studies are conducted in accordance with the study protocol, ICH-GCP guidelines, FDA regulations, and institutional SOPs. The CRC acts as a liaison between the PI, study participants, sponsors, and the Institutional Review Board (IRB) to ensure participant safety and data integrity.
 </p>
 <p>
  Key Responsibilities
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 <ul>
  <li>
   <strong>
    Study Startup &amp; Regulatory:
   </strong>
   Assist with protocol review, IRB submissions, and preparation of regulatory binders.
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    Participant Recruitment &amp; Screening:
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   Identify, recruit, and screen potential participants against inclusion/exclusion criteria.
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    Informed Consent:
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   Conduct the informed consent process, ensuring participants understand study requirements, risks, and benefits.
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    Study Visits &amp; Procedures:
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   Coordinate and conduct study visits, perform study procedures (e.g., ECGs, vitals), and manage participant follow-up.
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    Data Management:
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   Collect, record, and enter accurate source data into Electronic Data Capture (EDC) systems in a timely manner; resolve queries.
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    Specimen Management:
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   Collect, process, label, store, and ship laboratory specimens according to the protocol and IATA regulations.
  </li>
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    Safety &amp; Compliance:
   </strong>
   Monitor participant safety, record adverse events (AEs), and report serious adverse events (SAEs) promptly to the PI and sponsor.
  </li>
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    Investigational Product (IP):
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   Oversee proper receipt, storage, dispensing, and accountability of study drugs/devices.
  </li>
  <li>
   <strong>
    Site Visits:
   </strong>
   Host sponsor monitoring visits
  </li>
 </ul>
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 </p>
</div>


Clinical Research Coordinator  252171

<div><ul><li>Job Type: Officer of Administration</li>
<li>Regular/Temporary: Regular</li>
<li>Hours Per Week: 35</li>
<li>Salary Range: $69,500 - $72,500 Annual</li>
</ul><div><i>The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.</i></div><br>
<div></div>
<p></p>
<p>Position Summary</p>
<p>
The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies or under supervision provides study coordination for moderate complexity to high complexity clinical trials with supervision such as such as EFS and pivotal IDE/IND studies. Responsible for consent, screening for eligibility and identification of AES under minimal supervision. Completes subject follow ups, source documentation, device accountability and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high-quality work. They possess a moderate level of expertise across various skills and abilities within their function on the research team.</p>
<p></p>
<p>Responsibilities</p>
<p>
CLINICAL COORDINATION</p>
<ul>
<li>May create a recruitment plan that addresses the needs of the study population.</li>
<li>Demonstrates ability to screen participants for study eligibility &amp; enroll with accuracy in various databases.</li>
<li>Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC.</li>
<li>Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.</li>
<li>Understands protocol structure and how to interpret study requirements to ensure study compliance.</li>
<li>Understands proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>May complete P-card reimbursement to patients.</li>
<li>Processes subject visit billing and tracking of invoiceable items.</li>
<li>Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.</li>
<li>Obtains informed consent from subject.</li>
<li>Conducts all startup, active implementation, and closeout activities</li>
<li>Assesses studies for execution and troubleshoots potential implementation issues.</li>
<li>Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.</li>
<li>Triages subject concerns and issues appropriately.</li>
<li>Performs moderately complex study procedures with accuracy.</li>
</ul>
<p>DATA COORDINATION</p>
<ul>
<li>Enters data to complete forms (CRFs) on paper, databases, or EDCs.</li>
<li>Demonstrates ability to resolve moderately complex queries (e.g., data error changed numerous values in EDC).</li>
<li>Explains how to utilize information from the EMR and study databases.</li>
<li>Demonstrates the ability to complete moderately complex data collection during study visits.</li>
<li>Demonstrates the ability to document data in accordance with ALCOA-C principles.</li>
<li>Administers surveys and questionnaires.</li>
<li>Demonstrates ability to perform concomitant medications abstraction.</li>
<li>Builds patient research study charts.</li>
<li>Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.</li>
<li>Contributes to the development of processes and tools to capture data in accordance with ALCOA- C principles.</li>
<li>Demonstrates the ability to create CRFs, study documents, and tools.</li>
<li>Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA).</li>
<li>Creates and manage databases.</li>
</ul>
<p>REGULATORY COORDINATION</p>
<ul>
<li>Uses proper documentation techniques as outlined in the ICH-GCP guidelines.</li>
<li>Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.</li>
<li>Assists Regulatory manager in submission and management of IRB applications.</li>
<li>Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and understands how to report appropriately.</li>
<li>Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.</li>
<li>Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.</li>
<li>Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.</li>
<li>Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes.</li>
</ul>
<p>ADMINISTRATIVE RESPONSIBILITIES</p>
<ul>
<li>Provides other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.</li>
<li>Communicates with study participants such as sending study correspondence via mail or email.</li>
<li>Schedules subjects for research visits and FU appointments.</li>
<li>Checks study calendar for completion of study procedures.</li>
<li>Manages study supply inventory.</li>
<li>Utilizes documents and systems to track recruitment and retention of participants.</li>
<li>Participates in regular study meetings.</li>
<li>Provides logistic and regulation guidance to entry level employees on Federal and University policy and guidelines.</li>
<li>Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolve.</li>
</ul>
<p>TRAINING</p>
<ul>
<li>Gains appropriate training &amp; knowledge of EMR, CTMS, EDC, databases, etc. as assigned.</li>
<li>Attends and participates in all training assigned to this level including CITI, GCP, HIPAA.</li>
<li>Understands the disease process per program.</li>
<li>Participates in trainings specifically for maintaining certification as a Clinical Research Professional.</li>
<li>Provides training and mentorship for CRC clinical research staff on communication and teamwork best practices.</li>
<li>Attends and participates in all training assigned to this level.</li>
</ul>
<p>COMPETENCY</p>
<ul>
<li>Functional Knowledge: Demonstrates a strong understanding of the research subject matter specific to their role on the team.</li>
<li>Problem Solving: Analyzes moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.</li>
<li>Decision Making/Autonomy: Carries out research projects per guidelines and regulation with limited supervision, collaborating both independently and with the Principal Investigator (PI) and Clinical Research Manager. Requires a moderate degree of initiative and independent judgment.</li>
<li>Communication Skills: Summarizes and explains research information to others effectively.</li>
</ul>
<p>Perform other responsibilities as assigned.</p>
<p>
Please note that specific responsibilities may vary based on the needs of your unit or team. Certain units may require a greater focus on clinical, data, regulatory, or other specific needs. The role of Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.</p>
<p></p>
<p>Minimum Qualifications</p>
<ul>
<li>Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience.</li>
<li>Mastered competency of the specific responsibilities and duties from the CRC.</li>
<li>Technical competency in areas such as regulatory requirements, data management, and study documentation.</li>
<li>Experience in managing study-specific procedures, including patient eligibility screening, informed consent, and adverse event reporting.</li>
</ul>
<p></p><p>Other Requirements</p>
<ul>
<li>Participation in the medical surveillance program:
<ul><li>Contact with patients and/or human research subjects.</li>
</ul></li><li>Successful completion of applicable compliance and systems training requirements.</li>
</ul>
<p></p><p>Equal Opportunity Employer / Disability / Veteran</p>
<p>
Columbia University is committed to the hiring of qualified local residents.</p></div>

Clinical Research Coordinator I - Cardiology

Confluence Health

<div>Salary Range: $24.86 - $39.66 Overview:
<p>
Located in the heart of Washington, we enjoy open skies, snow-capped mountains, and the lakes and rivers of the high desert. We are the proud home of orchards, farms, and small communities. Confluence Health actively supports the communities we serve and their quality of life through our community support program and through our individual efforts as involved community members.</p><p></p><p><b><br>
Pool Employees of Confluence Health receive a range of benefits in addition to compensation.</b></p><ul><li>
Retirement Plan</li><li>
Pool Differential</li><li>
Sick Leave</li><li>
Shift Differential</li><li>
Employee Assistance Program</li></ul><p>
For more information on our Benefits &amp; Perks, click here!</p>
Summary:
<div><b>Please note: This is a pool position. No guarantee of hours.</b></div><div>
</div><div>
The Research Coordinator supports the clinical research objectives of the organization by coordinating the day‑to‑day conduct of multiple clinical research studies. This role collaborates with physician investigators, patients, sponsor and CRO representatives, and internal research staff to ensure that studies are conducted in accordance with approved protocols, regulatory requirements, and institutional policies. The Research Coordinator serves as a key operational liaison across stakeholders and is responsible for the coordinated execution of clinical trials from initiation through closeout. Success in this role requires the ability to effectively manage competing priorities across multiple studies while maintaining a high level of organization, accuracy, and attention to detail.</div><div>
</div><div><b>
Position Reports To: </b>Research Manager</div>
Essential Functions:
<ul><li><div>
Serve as the project manager for multiple clinical trials.</div></li><li><div>
Develop and execute a plan for how each study is to be conducted.</div><ul><li><div>
Prepare for the clinical trial before site initiation.</div></li><li><div>
Oversee the enrollment of qualified subjects into the study.</div></li><li><div>
Maintain direct &amp; immediate patient contact throughout the length of the study.</div></li><li><div>
Follow the visits and procedures outlined in the study protocol.</div></li><li><div>
Provide accurate investigational product accountability.</div></li><li><div>
Acquire (perform blood draws), process, and ship biological specimens.</div></li><li><div>
Handle resolution of queries related to study data.</div></li><li><div>
Complete the study close-out visit.</div></li><li><div>
Archive the study data per sponsor and FDA guidelines.</div></li><li><div>
Function as a liaison to the sponsor during monitoring visits and audits.</div></li></ul></li><li><div>
Track financial accruals for assigned studies by recording patient visits and expense reports.</div></li><li><div>
Keep current on required training and certifications, including, but not limited to GCP &amp; IATA.</div></li><li><div>
Travel to investigator meetings and other sponsor-related meetings as required.</div></li><li><div>
Required to maintain active Basic Life Support (CPR) certification.</div></li><li>
Performs other duties as assigned.</li></ul><div><i>
Demonstrate Standards of Behavior and adhere to the Code of Conduct in all aspects of job performance at all times.</i></div>
Qualifications:
<div>Required:</div><ul><li><div>
AA Degree with 2 years of related experience or a high school graduate with 4 years of related experience.</div></li><li><div>
Experience working in a healthcare setting.</div></li><li><div>
Knowledge of medical terminology.</div></li><li><div>
Professional interpersonal, written, and oral communication.</div></li><li><div>
Excellent computer skills.</div></li><li>
Active Medical Assistant - Certified (CM) license through the Washington State Department of Health or Medical Assistant &ndash; Phlebotomist (MA-P) certification.</li><li>
Basic Life Support (CPR) certification (within 90 days of hire).</li></ul><div><br>
Desired:</div><ul><li><div>
Experience working in clinical research.</div></li></ul>
Physical/Sensory Demands:
<div><i>O = Occasional, represents 1 to 25% or up to 30 minutes in a 2 hour workday.</i></div><div><i>
F = Frequent, represents 26 to 50% or up to 1 hour of a 2 hour workday.</i></div><div><i>
C = Continuous, represents 51% to 100% or up to 2 hours of a 2 hour workday.</i></div><div><br>
<b>
Physical/Sensory Demands For This Position:</b></div><ul><li><div>
Walking - F</div></li><li><div>
Sitting/Standing - F</div></li><li><div>
Reaching: Shoulder Height - F</div></li><li><div>
Reaching: Above shoulder height - F</div></li><li><div>
Reaching: Below shoulder height - F</div></li><li><div>
Climbing - O</div></li><li><div>
Pulling/Pushing: 25 pounds or less - F</div></li><li><div>
Pulling/Pushing: 25 pounds to 50 pounds - F</div></li><li><div>
Pulling/Pushing: Over 50 pounds - F</div></li><li><div>
Lifting: 25 pounds or less - O</div></li><li><div>
Lifting: 25 pounds to 50 pounds - O</div></li><li><div>
Lifting: Over 50 pounds - O</div></li><li><div>
Carrying: 25 pounds or less - F</div></li><li><div>
Carrying: 25 pounds to 50 pounds - F</div></li><li><div>
Carrying: Over 50 pounds - O</div></li><li><div>
Crawling/Kneeling - O</div></li><li><div>
Bending/Stooping/Crouching - F</div></li><li><div>
Twisting/Turning - O</div></li><li><div>
Repetitive Movement &ndash; F</div></li></ul><div><b>
Working Conditions:
</b></div><ul><li>Generally works indoors in a heat controlled, well-lit building. Occasionally out of doors during work related travel. Confined Office space.</li></ul><div><b>
Job Classification:</b></div><ul><li><div><b>
FLSA: </b>Non-Exempt</div></li><li><div><b>
Hourly/Salary: </b>Hourly</div></li></ul><div><b>
Physical Exposures For This Position:</b></div><ul><li><div>
Unprotected Heights - No</div></li><li><div>
Heat - No</div></li><li><div>
Cold - No</div></li><li><div>
Mechanical Hazards - Yes</div></li><li><div>
Hazardous Substances - Yes</div></li><li><div>
Blood Borne Pathogens Exposure Potential - Yes</div></li><li><div>
Lighting - No</div></li><li><div>
Noise - Yes</div></li><li><div>
Ionizing/Non-Ionizing Radiation - No</div></li><li><div>
Infectious Diseases - Yes</div></li></ul></div>

Research Coordinator (MA-C or MA-P)

Joslin Diabetes Center

<div>Overview:
<div>
The<b> Clinical Research Coordinator</b>&rsquo;s responsibilities may be associated with one or more clinical research project(s). The Coordinator works directly with pediatric patients and their families, and is responsible for coordinating assigned study/studies.</div><div></div><div><i><br>
As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. We require that all staff be vaccinated against influenza (flu) as a condition of employment.</i></div>
Responsibilities:
<ul><li>In all activities, adhere to Good Clinical Practice guidelines and maintain patient confidentiality per HIPAA regulations</li><li>
Identify potentially eligible participants using appropriate data sources</li><li>
Assess eligibility of potential study participants</li><li>
Become familiar with relevant content of all relevant study protocols</li><li>
Communicate clinical trial updates to other team members</li><li>
Describe studies to potential participants, explain rationale for and details of participation</li><li>
Obtain informed consent and assent, when appropriate</li><li>
Schedule study visits and prepare relevant materials for each visit (tubes, paperwork, etc.)</li><li>
Arrange participant travel, as applicable</li><li>
Collect primary data from study participants and their guardians</li><li>
After completing training, measure vital signs and perform other relevant procedures and tests</li><li>
Ensure that study visits and source documents are completed in accordance with study protocols, including verifying the work of other staff members</li><li>
Enter data into electronic data capture forms and respond to queries</li><li>
Process laboratory samples and ship to central laboratories</li><li>
Ensure timely reporting of abnormal findings to investigator and participants</li><li>
Document and communicate all serious adverse events and other safety reports to the study team and investigator</li><li>
Maintain up-to-date inventory of study supplies and place orders</li><li>
Modify study documents, such as informed consent form and recruitment materials, when needed</li><li>
Prepare documents for submission to IRB&mdash;may include initial protocol submissions, protocol amendments, annual continuing review, etc.</li><li>
Maintain all regulatory and subject binders in audit-ready condition</li><li>
Correspond with study sponsors, contract research organizations, and other collaborators, as applicable</li><li>
Assist with study start-up and close-out activities, as relevant</li><li>
Participate in study teleconferences, attend team meetings, and attend national meetings and/or investigator meetings, as relevant (may involve travel)</li><li>
Participate in occasional off-site recruitment events (requires some schedule flexibility)</li><li>
Other duties as assigned.</li></ul>
Qualifications:
<ul><li>Bachelor&rsquo;s degree (in a relevant field of study preferred)</li><li>
1-2 years of relevant post-graduate experience preferred</li><li>
Fluency in written and spoken English</li><li>
Spoken Spanish preferred</li><li>
Basic knowledge of Microsoft Office Suite and ability to navigate at a basic level within various web-based applications.</li><li>
Graphic design/layout skills (to design brochures, flyers, etc.) desirable</li><li>
Ability to follow general instructions and procedures, as provided.</li><li>
Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction).</li><li>
Meticulous attention to detail</li><li>
Professional and warm in demeanor, especially when relating to study participants and their families</li><li>
Ability to maintain confidentiality</li><li>
Ability to prioritize responsibilities &ndash; through completion.</li><li>
Ability to work independently and with others in the team - to interact respectfully with other employees, professional staff and/or external contacts.</li><li>
Excellent critical thinking and problem-solving abilities</li><li>
Ability to learn sophisticated concepts and detailed protocols quickly</li><li>
Ability to work with minimal oversight, after training period</li><li>
Ability to manage administrative complexity arising from multiple concurrent studies</li><li>
Flexible schedule as necessary to accommodate study patients and recruitment activities</li></ul><div></div><div><br>
The pay range listed for this position is the base hourly wage range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. Compensation may exceed the base hourly rate depending on shift differentials, call pay, premium pay, overtime pay, and other additional pay practices, as applicable to the position and in accordance with the law.</div>
(Min): USD $21.64/Hr. (Max): USD $24.37/Hr.</div>

Clinical Research Coordinator I

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