clinical research coordinator ii

DM Clinical Research

<div><p>The <b>Clinical Research Coordinator II</b> will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.</p><p><b><br>
DUTIES &amp; RESPONSIBILITIES</b></p><ul><li>
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.</li><li>
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:<ul><li>
a. Sponsor-provided and IRB-approved Protocol Training</li><li>
b. All relevant Protocol Amendments Training</li><li>
c. Any study-specific Manuals Training, as applicable</li><li>
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.</li></ul></li><li>
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.</li><li>
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.</li><li>
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.</li><li>
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.</li><li>
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.</li><li>
Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.</li><li>
Demonstrating adherence and compliance to the assigned protocols at their respective site(s).</li><li>
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)</li><li>
Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).</li><li>
Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)</li><li>
Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).</li><li>
Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.</li><li>
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.</li><li>
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).</li><li>
Being prepared for and available at all required company meetings.</li><li>
Submitting required administrative paperwork per company timelines.</li><li>
Occasionally attending out-of-town Investigator Meetings</li><li>
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives</li><li>
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent</li><li>
Facilitate effective communication between patients, healthcare providers, and research staff</li><li>
2Any other matters as assigned by management.</li></ul><p><b><br>
KNOWLEDGE &amp; EXPERIENCE</b><br>
</p><p><b>Education:</b></p><ul><li>
High School Diploma or equivalent required; Bachelor's degree preferred</li><li>
Foreign Medical Graduates preferred</li></ul><p><b>
Experience:</b></p><ul><li>
At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.</li></ul><p><b>
Credentials:</b></p><ul><li>
ACRP or equivalent certification is preferred</li></ul><p><b>
Knowledge and Skills:</b></p><ul><li>
Be an energetic, go-getter who is detail-oriented and can multi-task.</li><li>
Be goals-driven while continuously maintaining quality.</li><li>
Proficient communication and comprehension skills both verbal and written in the English language are required.</li><li>
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.</li></ul></div><p></p>

Clinical Research Coordinator II

Arizona Liver Health

<p></p><div><div><p><b>About Us:</b></p>
<p>
Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.</p></div><p></p><p><b><br>
Job Summary:</b></p>
<p>
Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II position in Tucson</p>
<p></p>
<p><b>Title: </b>Clinical Research Coordinator II (CRC2)</p>
<p><b>
Compensation:</b> $27.50 to $33 per hour, depending on experience</p>
<p><b>
Status:</b> Full-time</p>
<p></p>
<p><b>Essential job functions/duties:</b></p>
<p><i>
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.</i></p>
<ul>
<li>Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.</li>
<li>Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs.</li>
<li>Collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.</li>
<li>Develop management systems and prepare for study initiation</li>
<li>Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol</li>
<li>Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity about these protocols to staff and patients.</li>
<li>Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.</li>
<li>Responsible for meeting recruitment goals for each study.</li>
<li>May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.</li>
<li>Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.</li>
<li>Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.</li>
<li>Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.</li>
<li>Serves as a liaison to all physicians, employees, and third-party vendors.</li>
<li>Record data and study documentation</li>
<li>Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators and ensuring status of each patient is accurate.
<ul><li>Assign patient stipend pay card at screening</li>
<li>Document reason for screen-fail in real time</li>
</ul></li><li>Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:</li>
<li>Record data as directed using the appropriate media or platform</li>
<li>Follow procedures for access and security for electronic data entry</li>
<li>Review keyed data for accuracy as needed</li>
<li>Send data to the data collection center on a timely basis</li>
<li>Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports</li>
<li>Develop and/or edit source as needed independently or with Quality Assurance / Quality Control team to ensure compliance with protocol and EDC.</li>
<li>Correct and edit data as directed and as appropriate.</li>
<li>Informed Consent</li>
<li>Obtaining patient medical history and medication lists</li>
<li>Phlebotomy and basic laboratory tests</li>
<li>Processing &amp; shipping labs for central and local labs</li>
<li>Patient education and training</li>
<li>ECG</li>
<li>Administer questionnaires and assessments</li>
<li>Vital signs</li>
<li>Collect information for adverse event reporting</li>
<li>Assist with efficacy assessments</li>
<li>Data Entry and Query Resolution</li>
<li>Study drug administration, including injections</li>
<li>Tracking study supply inventory and reordering when necessary</li>
<li>Schedule patient visits in appropriate electronic systems</li>
<li>Documenting all patient visits and communications in progress notes</li>
<li>Document and record all AEs and SAEs as outlined in protocol</li>
<li>Monitor and report adverse events</li>
<li>Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.</li>
<li>Responsible for administrative duties including filing documents related to subject's participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.</li>
<li>Ensure W-9 and medical release forms are signed by subjects annually.</li>
<li>Management of site activities during audits and inspections</li>
<li>Management of ancillary staff as assigned
<ul><li>Train and supervise support staff (e.g., CRC I)</li>
<li>Mentor for externs</li>
<li>Train newly hired employees as either Research Assistant and/or CRC</li>
</ul></li></ul><ul><li>Prepare for quality assurance audits and regulatory inspections as needed</li>
<li>Act as contact person before, during and after audits and inspections</li>
<li>Provide all required documentation to auditors</li>
<li>Make all appropriate corrections as requested by auditors</li>
<li>Coordinate site response to audit/inspection findings.</li>
<li>Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.</li>
<li>Other responsibilities as delegated by manager.</li>
</ul>
<p></p><p><b>Knowledge/Skills/Abilities required:</b></p>
<ul>
<li>Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials.</li>
<li>Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management).</li>
<li>A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.</li>
<li>Interpersonal and communication skills&mdash;interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects and referral sources.</li>
<li>Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility protocol deviations, serious adverse events and other reporting requirements.</li>
<li>Able to perform all Job duties listed for Job Description for Phlebotomist</li>
<li>Know and understand all regulatory requirements associated with the conduct of the study assigned.</li>
</ul>
<p></p><p><b>Travel requirements:</b></p>
<ul>
<li>Some interoffice travel may be required with use of company vehicle or mileage reimbursement</li>
</ul>
<p></p><p><b>Education, credentials, and/or trainings required:</b></p>
<ul>
<li>Associates or Bachelor's degree in healthcare, clinical research management, or related required.</li>
<li>Master's degree or study-specific training preferred</li>
<li>GCP certification required at hire.</li>
<li>Experience and training in the conduct of clinical research and basic knowledge of medical terminology.</li>
<li>Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management)</li>
<li>Experience with data management and tracking software</li>
</ul>
<p><b>Benefits &amp; Perks:</b></p>
<ul>
<li>Health, Dental, Vision (with HSA plans and employer contribution)</li>
<li>3 weeks of PTO</li>
<li>5 days Sick Time</li>
<li>401K with 6% company match</li>
<li>Short &amp; Long Term Disability</li>
<li>CEUs / Educational Assistance</li>
<li>Shared company vehicles for required travel</li>
</ul>
<p><b><i>Our company requires COVID-19 vaccinations for all current and future employees (&amp; temporary employees). Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation.</i></b></p>
<p></p>
<p><b>EEO statement</b></p>
<p>
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.</p>
<p><b>
Notice to Staffing Agencies:</b> It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.</p></div><p></p>

Clinical Research Coordinator II (CRC2) Tucson

Evolution Research Group

<div><p><b>About Company:</b></p><p>
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I&ndash;IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.</p><p><b>
Why join us?</b> We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.</p><p><b>
Job Description:</b></p><p>
The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.</p><p><b>
Responsibilities:</b></p><p><b>
General</b></p><ul><li>
Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.</li><li>
Develop draft source documents and review the documents for accuracy and clarity prior to study start up.</li><li>
Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.</li><li>
Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.</li><li>
Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.</li><li>
Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.</li><li>
Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.</li><li>
Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.</li><li>
Contribute to the SOP review and development as delegated by the Site Director.</li></ul><p><b>
Study Management</b></p><ul><li>
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.</li><li>
Attend the investigator meeting for each assigned protocol, as appropriate.</li><li>
Completion of IRB study renewals and maintain copies of all IRB communications.</li><li>
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.</li><li>
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator</li><li>
Review and obtain informed consent from potential study volunteers.</li><li>
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.</li><li>
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.</li><li>
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.</li><li>
Ensure timely and accurate CRF completion for each study subject.</li><li>
Perform study close-out procedures.</li><li>
Store study records appropriately</li><li>
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG&rsquo;s objectives.</li></ul><p><b>
Skills and Qualifications:</b></p><ul><li><b>
Education and experience</b><ul><li>
High School Diploma or its equivalent; College degree preferred.</li><li>
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator</li><li>
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.</li><li>
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.</li><li>
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.</li><li>
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.</li></ul></li><li><b>
Requirements</b><ul><li>
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.</li><li>
Excellent communication skills (interpersonal, written, verbal)</li><li>
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)</li></ul></li></ul></div>

Clinical Research Coordinator-FT CRC

Stanford University

<div><p>Stanford University&rsquo;s Department of Neurosurgery is seeking a Clinical Research Coordinator II (CRCII) to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. Studies may include drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric and adult neuro-Oncology treatments. The CRCII will directly coordinate 2 or more clinical studies, supervise and delegate tasks for 5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, federal and grant funded clinical research studies. The CRC II will manage 1-3 CRCAs and will be responsible for training, assigning tasks and reviewing their work. This CRC II position is a full-time position, and a commitment of at least two years is required. CRC IIs are expected to be available up to 5 days a week on site. This position may require occasional evening and weekend hours.</p><p>
Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter.</p><p></p><p><b><br>
Duties include*:</b></p><ul><li>
Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.</li><li>
Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.</li><li>
Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.</li><li>
Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.</li><li>
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.</li><li>
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.</li><li>
Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.</li><li>
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.</li><li>
Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.</li><li>
Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.</li><li>
Hybrid Work Agreement.</li><li><i>Other duties may also be assigned.</i></li></ul><br>
<div><p><b>DESIRED QUALIFICATIONS:</b></p><ul><li>
Neurosurgery/ Oncology clinical trial coordination experience working with adults and children.</li><li>
Investigator Initiated clinical trial coordination experience.</li><li>
Experience with local and single-IRB submissions.</li><li>
Experience with protocol drafting and IND/IDE documents.</li><li>
Experience working with various databases such as REDCap, Oncore and various EDC systems.</li><li>
Knowledge of data-related research and presentation of research data.</li><li>
Enjoy working directly with patients and their families.</li><li>
Exceptionally organized and can balance multiple projects at once.</li><li>
Have the necessary patience and resourcefulness to interact well with individuals and their families.</li></ul><p></p><p><b><br>
EDUCATION &amp; EXPERIENCE (REQUIRED):</b></p><p>
Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.</p><p></p><p><b><br>
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):</b></p><ul><li>
Strong interpersonal skills, including the ability to work easily with research participants and research team members.</li><li>
Strong general computer skills and ability to quickly learn and master computer programs.</li><li>
Proficiency with Microsoft Office and Adobe.</li><li>
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB submissions.</li><li>
2-4 years clinical research coordinator experience.</li><li>
Knowledge of medical terminology.</li></ul><p></p><p><b><br>
CERTIFICATIONS &amp; LICENSES:</b></p><p>
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.</p><p></p><p><b><br>
PHYSICAL REQUIREMENTS*:</b></p><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><i>- 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.</i></li></ul><p><b><br>
WORKING CONDITIONS:</b></p><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><p></p><p><b><br>
WORK STANDARDS:</b></p><ul><li>
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.</li><li>
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.</li><li>
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.</li></ul><p></p><p><i><br>
The expected pay range for this position is $86,248 to $100,158 per annum.</i></p><p><i>
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.</i></p><p><i>
At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (</i><i>https://cardinalatwork.stanford.edu/benefits-rewards</i><i>) 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.</i></p><p><i>
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a </i><i>contact form</i><i>.</i></p><p><i>
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.</i></p><p><i>
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.</i></p></div></div>

Clinical Research Coordinator 2

The IMA Group

<div><div><div><b>Company Overview</b><br>
The Clinical Research Division at The IMA Group is a dynamic hub of expertise and innovation, committed to advancing healthcare through meaningful clinical trials and studies. Our dedicated team collaborates with industry leaders to conduct patient-focused research across diverse therapeutic areas. Guided by ethical practices and strict regulatory standards, we are driving groundbreaking medical solutions that shape the future of healthcare.</div><div></div><div><b>
Job Summary:</b><br>
</div><div></div><div><b>
IMA Clinical Research</b> is excited to welcome a <b>Clinical Research Coordinator (CRC)</b> with phlebotomy experience to our growing NYC team! In this role, you&rsquo;ll be at the heart of medical discovery, coordinating and managing clinical trials that bring new treatments to patients who need them most. You&rsquo;ll oversee studies in compliance with FDA requirements and GCP guidelines while working closely with investigators, sponsors, and clinical staff.</div><div>
</div><div><b>
Why join us?</b> You&rsquo;ll gain hands-on experience with innovative studies, grow your career in clinical research, and be part of a mission-driven team advancing tomorrow&rsquo;s medicine. The starting salary for this position is $60,000&ndash;$65,000 annually, based on experience.</div><div></div><div><b>
Key Responsibilities</b></div><ul><li><div>
Coordinate and manage clinical trials according to sponsor protocols and SOPs.</div></li><li><div>
Gain and maintain in-depth knowledge of study protocols and procedures.</div></li><li><div>
Serve as a key liaison with sponsors, CROs, monitors, IRBs, labs, and clinical teams.</div></li><li><div>
Support investigators and staff in ensuring successful study execution.</div></li><li><div>
Ensure timely reporting of adverse and serious adverse events per protocol.</div></li><li><div>
Maintain accurate and timely documentation in compliance with ALCOA principles.</div></li></ul><div></div><div><b>
Qualifications &amp; Skills</b></div><ul><li><div>
Minimum <b>2 years of clinical research and phlebotomy experience</b>.</div></li><li><div>
Clinical Research Coordinator certification (CCRC) preferred.</div></li><li><div>
Bachelor&rsquo;s degree required; Master&rsquo;s degree or equivalent experience preferred.</div></li><li><div>
Skilled in managing multiple projects independently.</div></li><li><div>
Strong communication, problem-solving, and leadership abilities.</div></li><li><div>
Clinical healthcare experience (e.g., vitals, diagnostic tests) is a plus.</div></li></ul><div></div><div><b>
What We Offer</b><br>
At IMA, we invest in our people and their futures:</div><ul><li><div><b>
Comprehensive Health Coverage</b>: Medical, Dental, and Vision insurance.</div></li><li><div><b>
Work-Life Balance</b>: Generous PTO, holidays, and floating holiday.</div></li><li><div><b>
Retirement Planning</b>: 401k with employer match.</div></li><li><div><b>
Financial &amp; Educational Support</b>: Tuition reimbursement and student loan repayment assistance (tax-free).</div></li><li><div><b>
Family Benefits</b>: Paid parental and maternity leave.</div></li><li><div><b>
Security &amp; Protection</b>: Company-paid life insurance, ADD, LTD, STD, plus voluntary coverage options.</div></li></ul></div><div></div><div><b><i>
The IMA Group is an Affirmative Action/Equal Opportunity Employer</i></b></div><div>
</div><div>
Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.</div><div></div><div>
#LI-EG1 #LI-ONSITE</div></div>

Clinical Research Coordinator- Manhattan, NY

ICON plc

<div>
 CDC II _ Office Based _ Hybrid
 <br/>
 <br/>
 ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
 <br/>
 <br/>
 We are currently seeking a Clinical Data Coordinator II to join our diverse and dynamic team. As a Clinical Data Coordinator II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.
 <br/>
 <br/>
 <strong>
  What You Will Be Doing
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures.
  </li>
  <li>
   Manage clinical and third-party data reconciliation based on edit specifications and data review plans.
  </li>
  <li>
   Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management.
  </li>
  <li>
   Address data related questions and recommend potential solutions.
  </li>
  <li>
   Identify root cause to systematically resolve data issues.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Your profile
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree in a relevant field, such as Life Sciences or Healthcare.
  </li>
  <li>
   Intermediate kNwledge of clinical data management within the pharmaceutical or biotechNlogy industry.
  </li>
  <li>
   Familiarity with data management software and systems (e.g., Medidata, Oracle RDC, or similar).
  </li>
  <li>
   Strong attention to detail and the ability to work effectively in a fast-paced environment.
  </li>
  <li>
   Excellent communication skills and the ability to collaborate with cross-functional teams.
  </li>
  <li>
   KNwledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  What ICON Can Offer You
  <br/>
  <br/>
 </strong>
 Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
 <br/>
 <br/>
 In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
 <br/>
 <br/>
 <strong>
  Our Benefits Examples Include
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Various annual leave entitlements
  </li>
  <li>
   A range of health insurance offerings to suit you and your family&rsquo;s needs.
  </li>
  <li>
   Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  </li>
  <li>
   Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family&rsquo;s well-being.
  </li>
  <li>
   Life assurance
  </li>
  <li>
   Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
   <br/>
   <br/>
  </li>
 </ul>
 Visit our careers site to read more about the benefits ICON offers.
 <br/>
 <br/>
 At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
 <br/>
 <br/>
 If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
 <br/>
 <br/>
 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.
 <br/>
 <br/>
 Are you a current ICON Employee? Please click here to apply
</div>


Senior CDC/CDC II

Houston Methodist

<div><p>At Houston Methodist, the Research Coordinator II position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.</p>
<div><b>
PEOPLE ESSENTIAL FUNCTIONS</b><br>
<ul><li>
Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.</li><li>
Identifies and recruits clinical research subjects and monitors enrollment goals.</li><li>
May conduct in-services to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.</li><li>
Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.</li></ul><br>
<b>
SERVICE ESSENTIAL FUNCTIONS</b><br>
<ul><li>
Participates in the Principal Investigator (PI) meetings.</li><li>
Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.</li><li>
Obtains vital signs and performs phlebotomy per training and competence; monitors participants' labs and notifies the PI of laboratory findings.</li></ul><br>
<b>
QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><br>
<ul><li>
Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.</li><li>
Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.</li></ul><br>
<b>
FINANCE ESSENTIAL FUNCTIONS</b><br>
<ul><li>
Assists with the budget development and Medicare coverage analysis.</li><li>
Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.</li></ul><br>
<b>
GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Assists PI and/or research nurse in the planning and design of source documents for protocol.</li><li>
Assists in developing procedures for laboratory collection and storage.</li><li>
Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.</li><li>
Proactively manages own professional development and completes My Development Plan.</li></ul><br>
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.</div>
<div><b>EDUCATION</b><br>
<ul><li>
Bachelor's degree</li></ul><br>
<b>
WORK EXPERIENCE</b><br>
<ul><li>
Four years of research experience</li></ul></div>
<b>LICENSES AND CERTIFICATIONS - REQUIRED</b><br>
<ul><li><div>
N/A</div></li></ul><br>
<b>
LICENSES AND CERTIFICATIONS - PREFERRED</b><br>
<ul><li><div>
CCRC - Certified Clinical Research Coordinator (ACRP) <b>OR</b></div></li><li><div>
CCRP - Certified Clinical Research Professional (SOCRA)
</div></li></ul><b>KNOWLEDGE, SKILLS, AND ABILITIES</b><br>
<ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations</li><li>
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security</li><li>
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles</li><li>
Ability to work independently</li><li>
Capable of handling challenging/difficult situations</li><li>
Demonstrates sound judgment and executes above average analytical skills</li></ul><p><b>
SUPPLEMENTAL REQUIREMENTS</b></p><p><b><br>
WORK ATTIRE</b></p><ul><li><div><br>
Uniform No</div></li><li><div>
Scrubs Yes</div></li><li><div>
Business professional No</div></li><li><div>
Other (department approved) Yes</div></li></ul><div><b>
ON-CALL*</b><br>
<ul><li><i>Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.</i></li></ul></div><ul><li><div><br>
On Call* No</div></li></ul><p><b>
TRAVEL**</b><br>
<i>**Travel specifications may vary by department**</i></p><ul><li><div><br>
May require travel within the Houston Metropolitan area No</div></li><li><div>
May require travel outside Houston Metropolitan area No</div></li></ul><p><b>
Company Profile:</b></p><p>
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&amp;M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.</p><p>
Houston Methodist is an Equal Opportunity Employer.</p></div>

Research Coordinator II - Transplant - Admin

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