clinical study coordinator

Milestone One

<div>
 
 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.
 
 
 
 
 
 
 Job Description
 
 
 
 
 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.
 
 
 
 
 
 
 In this job you will:
 
 
 
 
 
 <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.
 </li>
 <li>
 Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
 </li>
 <li>
 Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
 </li>
 <li>
 Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
 </li>
 <li>
 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.
 </li>
 <li>
 Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
 </li>
 <li>
 Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
 </li>
 <li>
 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.
 
 </li>
 </ul>
 <ul>
 <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>
 <li>
 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.
 </li>
 <li>
 Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
 </li>
 <li>
 Support the contract and budget negotiations and oversees Investigator/Site Payments.
 </li>
 <li>
 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.
 </li>
 <li>
 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.
 </li>
 <li>
 Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
 </li>
 <li>
 Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
 </li>
 <li>
 May be involved in the on-site training of additional staff as part of the SEO or other education programs.
 </li>
 <li>
 Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
 </li>
 <li>
 Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
 </li>
 <li>
 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.
 
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 
 
 Education
 
 
 
 
 
 
 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.
 
 
 
 
 Nephrology experience preferred.
 
 
 
 
 
 
 Certifications
 
 
 
 
 
 <ul>
 <li>
 Current Good Clinical Practice (GCP)
 </li>
 <li>
 International Air Transport Association (IATA)
 </li>
 <li>
 Current Basic Cardiopulmonary Resuscitation (CPR)
 </li>
 <li>
 Phlebotomy certification unless part of active professional licensure (RN or LPN)
 </li>
 <li>
 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.
 
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 
 
 Located in South Cook/ Will County, Chicago (On-site position).
 
 
 
 
 
 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!
 
 
 
</div>

Clinical Study Coordinator

AXCES Research Group

We are looking to hire a smart, motivated, and personable bad a$$ Research Coordinator to join our amazing team!The Clinical Research Coordinator (CRC) is responsible for the day‑to‑day coordination and execution of clinical research studies in compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This role works closely with investigators, participants, sponsors, and regulatory bodies to ensure the successful conduct of clinical trials.Key Responsibilities<ul><li>Coordinate and manage clinical research studies from start‑up through study close‑out</li><li>Screen, recruit, consent, and enroll study participants in accordance with protocol requirements</li><li>Conduct study visits, collect source data, and ensure accurate and timely documentation</li><li>Maintain investigational product binders, essential documents, and study accountability records</li><li>Ensure compliance with study protocols, IRB requirements, GCP, and institutional policies</li><li>Enter and manage data in electronic data capture (EDC) systems</li><li>Coordinate laboratory specimens, imaging, and other study‑related procedures</li><li>Act as a liaison between investigators, study participants, sponsors, CROs, and regulatory authorities</li><li>Prepare for and support monitoring visits, audits, and inspections</li><li>Track study timelines, enrollment metrics, and adverse events</li><li>Assist with study start‑up activities including feasibility assessments and submissions</li></ul>Preferred Qualifications<ul><li>Clinical Research Coordinator certification (e.g., ACRP‑CRC, SOCRA‑CCRP)</li><li>Experience working with IRBs and regulatory submissions</li><li>Phlebotomy, ECG, or other clinical skills (if required for studies)</li><li>Detail-oriented self-starter</li><li>Excellent communication and people skills (bilingual English/Spanish preferred)</li></ul>Up to ~20% Travel may be required for this role.We do exciting and meaningful work - visit us at www.axceshealth.org for more information about what we do. We're looking forward to meeting you!Local applicants onlyPay: $25.00 - $30.00 per hourBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Clinical Research Coordinator

Stanford University

<div>The Department of Ophthalmology (https://med.stanford.edu/ophthalmology) at Stanford Medicine is seeking an Assistant Clinical Research Coordinator to work under supervision of the principal investigator Professor Joyce Liao, MD, PhD (https://med.stanford.edu/profiles/joyce-liao). Our research focuses on eye-brain diseases that cause vision and neurological disability, and our goal is to perform clinical studies that will help us better understand optic nerve diseases and to identify best biomarkers that can predict disease outcome and to test promising therapies.
The Assistant Clinical Research Coordinator will perform many aspects of clinical research, including consenting patients, obtaining clinical information, organizing clinical database, and performing vision questionnaires and measurements. In addition, the Assistant Clinical Research Coordinator will obtain patient samples and work with the research team to process and store the samples. These may include spit kit for genetic studies, blood, and tissue. Most importantly, the Assistant Clinical Research Coordinator will work with all faculty and research team involved in the research and report back at regularly intervals to Dr. Liao, in order to ensure the success of our research.
We are looking for people with strong interpersonal skills, professionalism, and interest in eye-brain diseases. Priority will be given to those who is interested in staying on this position for 2 years or longer and those who have experience with clinical research in eye-brain diseases. 
Duties include:<ul><li>
Schedule and/or call subjects for appointments; contact participants with reminders or other requirements.</li><li>
Prepare, distribute, and process questionnaires.</li><li>
Perform clerical duties in the preparation of regulatory documents. Maintain all forms and documents, including consent forms and master subject logs. File all appropriate correspondence.</li><li>
Assist with the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews to gather data, as needed.</li><li>
Administer standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry. Perform quantitative review of forms, tests, and other measurements for completeness and accuracy.</li><li>
Extract data from source documents for research studies as directed. Collect data and complete case report forms.</li><li>
Perform basic measurements and tests on patients according to protocol, such as obtaining vital signs and performing phlebotomy and EKG, after appropriate training/certification. Collect study specimens according to protocol.</li><li>
Prepare, process, and ship specimens/samples accurately under well-defined requirements.</li><li>
Order and maintain equipment and supplies.</li><li>
Process study compensation payments and thank you letters to subjects upon completion of trial activities. Assist with post-study activities, as needed.</li><li>- Other duties may also be assigned</li></ul> 
The expected pay range for this position is $29.44 to $33.26 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 (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 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.
<div>DESIRED QUALIFICATIONS:
Experience working with research study participants or patients in professional setting, good communication skills, ability to provide professional and high quality interactions in a calm and organized manner. 
EDUCATION &amp; EXPERIENCE (REQUIRED):
Two year college degree and one year of relevant experience or an equivalent combination of experience, education, and training. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
General knowledge of medical terminology. 
CERTIFICATIONS &amp; LICENSES:
Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy 
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></div></div>

Assistant Clinical Research Coordinator

Columbia University

<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>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.</div> 
<div></div>

Position Summary

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.

Responsibilities

CLINICAL COORDINATION
<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>
DATA COORDINATION
<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>
REGULATORY COORDINATION
<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>
ADMINISTRATIVE RESPONSIBILITIES
<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>
TRAINING
<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>
COMPETENCY
<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>
Perform other responsibilities as assigned.

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.

Minimum Qualifications
<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>
Other Requirements
<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>
Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.</div>

Clinical Research Coordinator I - Cardiology

University of Pennsylvania

<div>University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News &amp; World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn&rsquo;s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America&rsquo;s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
Posted Job Title
Clinical Research Coordinator A-01 (25 hr/wk)
Job Profile Title
Clinical Research Coordinator A-01
Job Description Summary
The Center for Weight and Eating Disorders at the University of Pennsylvania Perelman School of Medicine seeks a part-time Clinical Research Coordinator (CRC). The candidate will help coordinate an industry-funded study that will assess the long-term effects of behavioral treatment and weight loss medication on appetite, eating behavior, and eating disorder symptoms.
 
 
The CRC will assist with: recruiting and screening participants; conducting patient assessments, including behavioral testing; coordinating subject screenings and study visits; coordinating regulatory paperwork; documenting and reporting adverse events; preparing study materials and ordering study-specific supplies; completing progress and data safety monitoring plan reports; maintaining study charts; and entering study data.
Job Description
The Center for Weight and Eating Disorders at the University of Pennsylvania Perelman School of Medicine seeks a part-time Clinical Research Coordinator (CRC). The candidate will help coordinate an industry-funded study that will assess the long-term effects of behavioral treatment and weight loss medication on appetite, eating behavior, and eating disorder symptoms.
Responsibilities
The CRC will assist with: recruiting and screening participants; conducting patient assessments, including behavioral testing; coordinating subject screenings and study visits; coordinating regulatory paperwork; documenting and reporting adverse events; preparing study materials and ordering study-specific supplies; completing progress and data safety monitoring plan reports; maintaining study charts; and entering study data.
Position is contingent on performance and continued funding.
Qualifications 
Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. Must be able to interact sensitively with patients seeking weight loss treatment. Effective problem solving, communication, and writing skills are required. Must be able to multi-task. Demonstrated ability to work as part of a team as well as independently.
We seek candidates who embrace and reflect diversity in the broadest sense. The University of Pennsylvania is an EOE. Minorities/Women/Individuals with disabilities/Protected Veterans are encouraged to apply.
Working Conditions
Office, Library, Computer Room; Requires extensive safety 
Physical Effort 
Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$22.36 - $22.75 Hourly Rate
Salary offers are made based on the candidate&rsquo;s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job&rsquo;s level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.
Special Requirements 
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits<ul><li>
Health and Life: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family&rsquo;s health and welfare.</li><li>
Retirement: Penn offers generous retirement plans to help you save for your future. Penn&rsquo;s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.</li><li>
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family&mdash;whatever your personal needs may be.</li><li>
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you&rsquo;re newly hired, you won&rsquo;t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.</li><li>
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That&rsquo;s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.</li><li>
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University&rsquo;s libraries and athletic facilities, or visit our arboretum and art galleries. There&rsquo;s always something going on at Penn, whether it&rsquo;s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you&rsquo;re right in the middle of the excitement&mdash;and you and your family can enjoy many of these activities for free.</li><li>
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.</li><li>
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.</li></ul></div>

Clinical Research Coordinator A-01 (25 hr/wk)

Joslin Diabetes Center

<div>Overview:
<div>
The Clinical Research Coordinator&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> 
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.</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> 
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

<div>The Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies within the Stanford Medicine Children&rsquo;s Health Center for Pediatric IBD and Celiac Disease. This is an exciting opportunity for a talented individual to contribute to groundbreaking research in the field of pediatric gastroenterology while working in a collaborative and supportive environment. Join us in making a real difference in the lives of young patients and advancing the science of pediatric IBD and celiac disease! 
The CRCA will coordinate complex aspects of multiple clinical studies and work under the general direction of multiple principal investigators and/or supervisor. The CRCA will support federal and non-federal clinical research studies including epidemiological and investigative work in support of clinical trials, clinical research or biomedical research focusing on &ldquo;bench to bedside&rdquo; technology. The primary work will include supporting pilot studies of Pediatric Gastroenterology faculty (from study start up to closure), as well as federally funded and industry-sponsored studies in the future. The CRCA will need to provide their own transportation with the ability to get to/from other off-site clinics. This position will be onsite and may require occasional evening and weekend hours. 
Duties include:<ul><li>
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.</li><li>
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.</li><li>
Coordinate collection of study specimens and processing.</li><li>
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.</li><li>
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.</li><li>
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.</li><li>
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.</li><li>
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.</li><li>
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.</li><li>
Participate in monitor visits and regulatory audits.</li></ul><ul><li> 
- Other duties may also be assigned</li></ul>
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. 
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. The pay range for this position working in the California Bay area is $34.56 to $40.30 hourly.
<div>DESIRED QUALIFICATIONS: 
EDUCATION &amp; EXPERIENCE (REQUIRED): 
Two year college degree and two years related work experience or a Bachelor&rsquo;s degree in a related field or an equivalent combination of related education and relevant experience. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):<ul><li> Strong interpersonal skills.</li><li> Proficiency with Microsoft Office.</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></ul><ul><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:
Occasional evening and weekend hours.</div></div>

Clinical Research Coordinator Associate

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