oncology clinical research coordinator

Pratia

<p>Pratia is a network of world-class, community-based oncology investigative sites capable of performing complex Phase 1 clinical trials. We emphasize standardization and centralization of clinical trial operations to ensure efficiency, high-quality data, and faster study start-up timelines. With a patient-centric approach and collaboration with our pharmaceutical, biotech, and CRO partners, we are dedicated to delivering reliable outcomes that support groundbreaking medical advancements. As our team continues to grow in the US, we are hiring a <b>clinical research coordinator </b>who will support the safe, compliant, and efficient conduct of early-phase oncology clinical trials across the P1 Pratia Network.</p><p>As a <b>Clinical Research Coordinator</b>, you will:</p><ul><li>Assist with daily clinical trial activities from study start-up through close-out.</li><li>Schedule and facilitate study visits, assessments, and follow-up appointments.</li><li>Support investigational product accountability when delegated.</li><li>Track and document protocol deviations; support corrective actions.</li><li>Assist with site qualification, initiation, monitoring, and close-out visits.</li><li>Conduct pre-screening and confirm eligibility according to protocol criteria.</li><li>Coordinate labs, imaging, procedures, and specialist referrals.</li><li>Document protocol compliance, including investigational product adherence.</li><li>Maintain essential regulatory documents per ICH-GCP, FDA, and institutional standards.</li><li>Support IRB submissions, amendments, safety reports, and renewals.</li><li>Maintain delegation logs and protocol version control.</li><li>Promote adherence to SOPs and process improvement initiatives.</li><li>Enter and verify data in EDC systems within sponsor timelines.</li><li>Resolve data queries promptly and collaborate with monitors.</li><li>Oversee completion of case report forms (CRFs).</li><li>Assist with audits and inspections.</li><li>Coordinate with Pharmacy for IP accountability and dispensing when delegated.</li><li>Coordinate with Laboratory for specimen processing and shipping.</li><li>Coordinate with Radiology for protocol-window imaging.</li><li>Document and follow up on adverse events (AEs) and serious adverse events (SAEs).</li><li>Report safety events per protocol and regulatory timelines.</li><li>Assist with feasibility, qualification, and study start-up activities.</li><li>Track study visit completion and billable items.</li></ul><p><b>Knowledge, Skills and Abilities</b></p><ul><li>Working knowledge of ICH-GCP and FDA regulations</li><li>Attention to detail and accuracy in documentation, data entry, and regulatory records.</li><li>Proficiency with clinical trial systems (e.g., EDC, CTMS) and standard office software.</li></ul><p><b>Requirements</b></p><ul><li>High school diploma or GED</li><li>Prior experience as a CRC or equivalent clinical research role (oncology preferred).</li></ul><p>The anticipated salary range for this role is 65-80k/yearly. Actual compensation will depend on experience, location, and other factors.</p><p>Candidates must be authorized to work in the United States without current or future sponsorship.</p><p>Pay: Up to $80,000.00 per year</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Health insurance</li></ul><p>Work Location: In person</p>

Clinical Research Coordinator

Mount Sinai Health System

<div><p>The Department of Radiation Oncology at The Mount Sinai Hospital is seeking a highly motivated Clinical Research Coordinator II (CRC II) to join our growing research team. This position offers an exciting opportunity to contribute to cutting-edge cancer research within a nationally recognized academic medical center and NCI-designated Comprehensive Cancer Center.</p><p></p><p><br>
We are looking for an organized, detail-oriented, and compassionate individual with strong communication and interpersonal skills. The ideal candidate will be comfortable working with a large, multicultural, and ethnically diverse patient population and will demonstrate empathy, professionalism, patience, and sound judgment when interacting with patients undergoing cancer treatment. Fluency in Spanish is preferred but not required.</p><p></p><p><br>
Candidates should have prior clinical research experience and a strong interest in oncology research. We are seeking individuals who are committed to professional growth. This position offers substantial exposure to clinical trial operations, regulatory affairs, data management, patient-facing research activities, and multidisciplinary cancer care within a leading academic medical center.</p><p></p><p><b><br>
About the Department</b></p><p>
The Tisch Cancer Institute (TCI) is a vital component of the Icahn School of Medicine at Mount Sinai and plays a key role within the Mount Sinai Health System, one of the largest healthcare systems in the nation. TCI is an NCI-designated Comprehensive Cancer Center dedicated to advancing cancer prevention, diagnosis, treatment, and survivorship through innovative research and patient-centered care.</p><p></p><p><br>
The Department of Radiation Oncology works closely with TCI and its Cancer Research Support Unit (CRSU) to provide the infrastructure, expertise, and resources necessary to support patient-based cancer research. The department maintains an active clinical research portfolio that includes National Cancer Institute (NCI)-sponsored trials, cooperative group studies, industry-sponsored clinical trials, investigator-initiated research, translational studies, and quality-of-life research.</p><p></p><p><br>
The CRC II will work closely with physicians, research nurses, medical physicists, sponsors, and other clinical research professionals while gaining valuable experience in the conduct and management of oncology clinical trials. With comprehensive training and mentorship, the CRC II will assume responsibility for coordinating clinical research studies of increasing complexity and significance.</p><p><b>
Primary Responsibilities</b></p><p>
Clinical Trial Coordination</p><ul><li><p>
Coordinate day-to-day activities for clinical research studies conducted within the Department of Radiation Oncology.</p></li><li><p>
Assist with study-related activities including participant outreach, scheduling, screening, and subject registration with sponsoring agencies.</p></li><li><p>
Screen potential participants for eligibility according to protocol-specific criteria.</p></li><li><p>
Obtain informed consent under investigator supervision and educate participants regarding study requirements and procedures.</p></li><li><p>
Serve as a primary point of contact for study participants throughout their research experience, providing education, support, and coordination of study-related activities.</p></li><li><p>
Conduct patient interviews and administer study-related questionnaires addressing quality of life, symptom burden, social support, mental health, cognitive function, physical mobility, and related topics.</p></li><li><p>
Coordinate protocol-required procedures, laboratory testing, imaging studies, and follow-up visits.</p></li><li><p>
Collect, process, track, and ship biological specimens, imaging studies, and other protocol-required materials.</p></li><li><p>
Ensure protocol compliance and coordinate study activities with investigators, clinical staff, and ancillary departments.</p></li><li><p>
Serve as a liaison among investigators, study participants, sponsors, and institutional departments.</p></li><li><p>
Assist in safeguarding participant rights and ensuring adherence to ethical research practices.</p></li><li><p>
Manage and track participant reimbursement and study-related compensation when applicable.</p></li><li><p>
Develop expertise in the management of oncology clinical trials, including NCI-sponsored, cooperative group, industry-sponsored, and investigator-initiated studies.</p></li></ul><p></p><p><br>
Data Management and Study Oversight</p><ul><li><p>
Conduct detailed electronic medical record reviews and abstract clinical data.</p></li><li><p>
Ensure accurate and complete compilation of subject data through electronic chart reviews and source documentation review.</p></li><li><p>
Collect, enter, and maintain accurate study data within case report forms (CRFs), electronic data capture systems, REDCap databases, and institutional databases.</p></li><li><p>
Ensure timely and accurate submission of study data according to protocol and sponsor requirements.</p></li><li><p>
Maintain complete and compliant source documentation, regulatory files, and subject records.</p></li><li><p>
Prepare for and participate in sponsor monitoring visits, audits, and quality assurance reviews.</p></li><li><p>
Meet with internal and sponsor-appointed monitors to ensure accuracy of subject data and compliance with research protocols.</p></li><li><p>
Assist investigators with data reporting, analysis, and study-related documentation as needed.</p></li></ul><p></p><p><br>
Regulatory Compliance</p><ul><li><p>
Assist with the preparation and maintenance of regulatory submissions, including new protocols, amendments, continuing reviews, and study closures.</p></li><li><p>
Report adverse events and serious adverse events in accordance with institutional policies, sponsor requirements, Good Clinical Practice (GCP), and federal regulations.</p></li><li><p>
Ensure compliance with Institutional Review Board (IRB), sponsor, and regulatory requirements.</p></li><li><p>
Coordinate translation of study documents and informed consent forms when required.</p></li><li><p>
Assist investigators and regulatory staff with protocol implementation and ongoing regulatory maintenance.</p></li><li><p>
Additional Responsibilities</p></li><li><p>
Participate in Study Initiation Visits (SIVs), investigator meetings, sponsor training sessions, and site qualification visits.</p></li><li><p>
Attend departmental, institutional, and sponsor-required educational programs and training activities.</p></li><li><p>
Communicate with internal and external healthcare providers to obtain study-related documentation and long-term follow-up information.</p></li><li><p>
Assist in training and mentoring new research staff on study procedures, patient registration, data management, and specimen handling.</p></li><li><p>
Participate in professional development activities designed to enhance clinical research, regulatory, and oncology-specific knowledge.</p></li><li><p>
Contribute to the continued growth and success of the Department's clinical research program.</p></li><li><p>
Perform other research-related duties as assigned.</p></li></ul><ul><li><p>
Bachelor's degree required; Master's degree in a scientific, health-related, or research field preferred.</p></li><li><p>
Minimum of two years of experience in Clinical Research in roles such as Clinical Research Coordinator, Study Coordinator, Data Manager, Research Assistant, or related clinical research position</p></li><li><p>
Experience working in a healthcare, academic medical center, or clinical research environment preferred</p></li><li><p>
Oncology clinical research experience preferred</p></li><li><p>
Working knowledge of Good Clinical Practice (GCP), human subject?s protections, and federal research regulations preferred</p></li><li><p>
Experience with electronic medical records and clinical research databases preferred.</p></li><p></p><li><p><br>
Excellent written, verbal, and interpersonal communication skills.</p></li><li><p>
Strong organizational skills with the ability to manage multiple studies and competing priorities.</p></li><li><p>
Exceptional attention to detail and commitment to data quality.</p></li><li><p>
Ability to establish rapport with patients undergoing cancer treatment and their families.</p></li><li><p>
Professional demeanor and ability to interact effectively with physicians, nurses, sponsors, and research staff.</p></li><li><p>
Comfortable communicating clinical information to healthcare professionals and research stakeholders.</p></li><li><p>
Strong computer proficiency, including Microsoft Office applications and electronic medical record systems.</p></li><li><p>
Ability to work independently while functioning effectively as part of a multidisciplinary team.</p></li><li><p>
Spanish language proficiency preferred.</p></li></ul><p></p><p><br>
Non-Bargaining Unit, 861 - Radiation Oncology - ISM, Icahn School of Medicine</p><p><b>
Strength through Unity and Inclusion</b></p>
<p>
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai&rsquo;s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.</p>
<p>
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.</p>
<p><b>
About the Mount Sinai Health System:</b></p>
<p>
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time &mdash; discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients&rsquo; medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.</p>
<p><b>
Equal Opportunity Employer</b></p>
<p>
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.</p></div>

Clinical Research Coordinator II-Radiation Oncology

Rocky Mountain Cancer Centers

<div>Overview:
<div>
Rocky Mountain Cancer Centers, Colorado's largest and most comprehensive provider of cancer care has an exciting opportunity for an experienced Clinical Research Coordinator/RN at our Midtown location in Denver.</div><div></div><div><br>
Bring your <b>established Oncology and or Research experience</b> and join a team dedicated to providing an excellent experience to patients.</div><div></div><div><br>
We realize that it sounds clich&eacute; but it is true - taking care of cancer patients is a calling. It&rsquo;s much more than a job. Each of us has a unique story that brought us to Rocky Mountain Cancer Centers (RMCC), but those stories usually share common themes of care, compassion, and commitment.</div><div></div><div><br>
No matter the role each RMCC team member serves in, the goal is the same: to provide the best care possible for each and every one of our patients. Whether we are a nurse holding our patient&rsquo;s hand, or a scheduler on the phone finding an appointment that fits into a patient&rsquo;s schedule, we are deeply connected to our patients and do what we can to help.</div><div></div><div><br>
If this sounds like you, we&rsquo;d love to have you join our team.</div><div></div><p><br>
 Salary Range: $60,000-$75,000 for non-nurses and $80,000-$97,000 for nurses
</p><p>Pay is based on several factors including but not limited to education, work experience, certification, etc. As of the date of this posting, in addition to your salary, RMCC offers the following benefits for this position, subject to eligibility requirements: Health, dental, and vision plans; wellness program; health savings account; flexible spending accounts; potential for research bonus depending on financials of department after one year of employment; 401(k) retirement plan; life insurance, short-term disability insurance; long-term disability insurance, Employee Assistance Program; PTO, holiday pay, tuition reimbursement, and employee paid critical illness and accident insurance.</p><div></div><div><br>
A wide salary range is posted for this position and any job offer is based upon a salary analysis to comply with the Colorado Equal Pay for Equal Work Act. The salary analysis considers relevant experience, education, and certifications as compared to others doing substantially similar work. While all offers are compliant with the Colorado Equal Pay for Equal Work Act, there is no guarantee an offer will be at the top of the posted range based on the salary analysis.</div>
Responsibilities:
<ul><li>Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.</li><li>
Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.</li><li>
Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.</li><li>
Maintains regulatory documents in accordance with USOR SOP and applicable regulations.</li><li>
Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.</li><li>
May collaborate with Research Site Leader in the study selection process.</li><li>
Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors.</li><li>
Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.</li><li>
May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.</li><li>
May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.</li><li>
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.</li><li>
Prepare and manage patient visits (source document creation, order entry)</li><li>
Investigational drug ordering and accountability management</li><li>
Lead weekly patient review calls with CRCs in assigned group</li><li>
Manage adverse events and dose modifications coordination with investigators and CRCs</li><li>
Complete disease assessments and route for MD review and sign-off</li><li>
Communicate with MDs, APPs and other clinic team members regarding research patients</li><li>
Back-up for patient consents, including re-consents (in person or remotely)</li></ul>
Qualifications:
<ul><li><ul><li>Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.</li><li>
SoCRA or ACRP certification preferred.</li></ul><div>
or</div><ul><li><p>
Graduate from an accredited program for nursing education (BSN preferred). Minimum seven years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred.</p></li><p></p><li><div><b><br>
Specialized Knowledge/Skills -</b></div><ul><li><div>
Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents.</div></li><li><div>
Ability to work independently, organize, prioritize, and follow through with results</div></li><li><div>
Ability to solve practical problems and implement solutions</div></li><li><div>
Strong ability multi-task</div></li><li><div>
Must have excellent communication skills</div></li><li><div>
Excellent time management skills</div></li><li><div>
Must have a strong interpersonal skills to be able to interact with multiple people on many different levels</div></li><li><div>
Must have a high level of attention to detail</div></li><li><div>
Must be able to work in a fast paced environment</div></li><li><div>
Attention to details and accuracy</div></li><li>
Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medical, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCP concepts</li><li>
Experience with computer data entry and database management</li></ul></li></ul></li></ul><p></p><p><br>
Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.</p><p></p><p><br>
Physical Requirements (Lifting, standing, etc.) &ndash; Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)</p><p></p><p><br>
All qualified candidates are required to pass a background check and non-federal drug test (which excludes marijuana) post offer of employment and prior to hire.</p><p></p><p><br>
This job posting will remain open until we have identified an adequate applicant pool. Applicants are strongly encouraged to apply early. To apply for this position, start the process by clicking the blue &quot;apply&quot; button.</p></div>

Clinical Research Patient Coordinator

Texas Oncology

<div>Overview:<p></p><div><b><br>
Texas Oncology</b> is looking for a <b>Research Admin Coordinator </b>to join our team!<b> </b>This position will support the <b>Mary Crowley</b> location in<b> Dallas</b>. This position is a Full Time position. Typical hours are Mon-Fri from 7am-6:00pm.</div><p></p><p><b><br>
Texas Oncology </b>is the largest community oncology provider in the country and has approximately 600+ providers in 220+ sites across Texas and southeastern Oklahoma. Our founders pioneered community-based cancer care because they believed in making the best available cancer care accessible to all communities, allowing people to fight cancer at home with the critical support of family and friends nearby. Our mission is still the same today - at Texas Oncology, we use leading-edge technology and research to deliver high-quality, high-touch, evidence-based cancer care to help our patients achieve &ldquo;More breakthroughs. More victories.&rdquo; &reg; in their fight against cancer. Today, <b>Texas Oncology</b> treats half of all Texans diagnosed with cancer on an annual basis.</p><p></p><p><b><br>
Why work for us?</b></p><p>
Come join our team that is responsible for helping lead Texas Oncology in treating more patient diagnosed with cancer than any other provider in Texas. We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous PTO program, a 401k plan that comes with a company match, a Wellness program that rewards you practicing a healthy lifestyle, and lots of other great perks such as Tuition Reimbursement, an Employee Assistance program and discounts on some of your favorite retailers.</p><div><br>
</div><p><b>What does the Research Admin Coordinator</b><b> do? (Including but not limited to)</b></p><p>
Under minimal supervision, the Research Admin Coordinator performs duties to provide administrative and organization support for the Research office including creating and maintaining correspondence, filing, preparing various reports, and project managment. Coordinates facilities and office management functions including mail, switchboardand payroll. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.</p><br>
<p></p>
Responsibilities:
<div><b>
The essential duties and responsibilities (including but not limited to)</b></div><ul><li>
Interacts with Research Sponsors, sitepersonnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.</li><li>
Coordinates administrative support for the Research Office including switchboard, mailroom and payroll processing.</li><li>
Coordinates facilities needs for the office including furniture/fixtures/equipment, communications systems and space planning. Maintains inventories of office supplies including stationary and forms.</li><li>
Ensures maintenance of office equipment and troubleshoots problems with vendors as needed. Answers telephones, takes accurate messages, and screens and directs calls in a professional manner.</li><li>
Coordinates and schedules meetings and appointments as necessary. Prepares materials needed by the Department for meetings, correspondence, appointments, phone calls etc.</li><li>
Prepares department coorespondence and designs, implements,and updates forms for use within the office by applying knowledge of software applications.</li><li>
Maintains files in an organized and accessible manner including updating informatin, purging files on a regular basis, and creating new filing systems as needed.</li><li>
Maintains department personnel records ina confidential manner in accordance with all company policies and procedures.</li><li>
Coordinates research medical records maintenance and ensures data is handled in accordance with department processes and procedures. Communicates with all levels of management on information relating to projects and other requests.</li><li>
Acts as a liaison between management and other staff. May oversee the daily activities of department administrative support staff.</li><li>
Serves as the primary point of contact for patients and visitors by managing front desk operations, including client check-in and check out processes with accuracy and efficiency.</li><li>
Process clinical trial reimbursements in accordance with study protocols and orgainzational guidelines, ensuring timely and compliant submissions.</li><li>
Provide administrative and operational support for the Patient Billing Reconciliation (PBR) process, including documentation tracking and coordination with internal teams.</li><li>
Maintain and ensure scheduling accuracy, proactively updating calendars to reflect patient visits, research appointments, and provider availability.</li><li>
Triages incoming phone calls, addressing patient inquiries, directing calls appropriately, and escalating urgent matter to the appropriate clinical or research staff.</li><li>
Collaborate with clinical and research teams to support seamless patient flow and enhance overall patient experience.</li><li>
Ensure adherence to compliance standards, confidentiality regulations, and clinical research protocols in all interactions and documentation.</li></ul><br>
<div></div>
Qualifications:
<div><b>
The ideal candidate for the Research Admin Coordinator</b><b> position will have the following background and experience:</b></div><ul><li>
High School Diploma or equivalent required.</li><li>
At least seven years of secretarial and/or office administation experience required.</li><li>
At least one year of medical office experience preferred.</li><li>
Experience in clinical research strongly preferred.</li><li>
Must be proficient in Microsoft Office (Outlook,PowerPoint, Excel, etc.).</li><li>
Must have strong communication and prioritization skills and be very detail oriented.</li></ul><div><b>
Physical Demands:</b> The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping and stretching. Requires occassional liftinf of up to 40 pounds. Requires ey-hand coordination and manual dexterity sufficient to operatore a keyboard, potocopier, telephone, calculator, and other office equipment. Requires hearing and vision corrected to normal range.</div><div></div><div><b><br>
Work Environment:</b> The work environment characteristics described here are representative of those of an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work performed in an office environment and involves frequent contact with managment and staff.</div></div><div></div>

Research Admin Coordinator- Mary Crowley

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations.</p><p></p><p><br>
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Coordinates regulatory correspondence across internal stakeholders and external institutions.</li><li>
Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.</li><li>
Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.</li><li>
Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.</li><li>
Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.</li><li>
Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.</li><li>
Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.</li><li>
Provides input to the investigators in consent form creation and protocol editing.</li><li>
Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.</li><li>
Prepares for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.</li><li>
Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.</li><li>
Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.</li><li>
Maintains regulatory database as applicable. Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.</li><li>
Keeps the study team and supervisor informed of protocol related issues.</li><li>
Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.</li><li>
Practices a high level of integrity and honesty in maintaining confidentiality.</li><li>
Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.</li><li>
Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.</li><li>
Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues. Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.</li><li>
Performs other job related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree.</li><li>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Department Specific Criteria</b></h2></div><div><ul><li>
Two or more years of experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.</li><li>
Demonstrated knowledge of regulatory processes and applicable regulations.</li><li>
Ability to manage regulatory aspects of multiple research projects.</li><li>
Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, sponsors, their representatives, and other business partners.</li><li>
Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.</li><li>
Ability to serve as a resource to clinical investigators and staff.</li><li>
Ability to manage shifting priorities in short time frames.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Certification in Clinical Research, SOCRA or other preferred.</li><li>
Should have excellent oral and written communication skills.</li><li>
Knowledge of medical/scientific terminology.</li><li>
Excellent organization skills; ability to multi-task.</li><li>
Strong computer skills including Microsoft Office Suite.</li><li>
High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organization.</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div>

Regulatory Affairs Associate - Clinical Research

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><div>
The Texas Children&rsquo;s Cancer and Hematology Centers (TXCH) Research Coordinator II is responsible for supporting the implementation and coordination of day-to-day activities for clinical research protocols across various oncology teams. This role helps ensure accurate data collection, documentation, organization, and the safety of study participants. The Research Coordinator II also serves as a liaison among study participants, investigators, sponsors, and other healthcare professionals involved in research and patient care.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><div><p><b>
Supports daily operations for a research study or clinical trial</b></p><ul><li>
Consults with the Principal Investigator (PI) and providers regarding research data.</li><li>
Assists the PI and/or providers with study patient enrollment.</li><li>
Interviews, screens, and recruits patients for therapeutic and non-therapeutic studies; performs the informed consent process for biology, procurement, and registry studies; and explains processes and procedures to educate participants about the research study.</li><li>
Collects patient information through direct interviews, questionnaires, and chart abstraction; processes documents and enters information into databases or case report forms (CRFs).</li><li>
Collaborates with study teams and physicians to determine patient eligibility for research protocols.</li><li>
May schedule research participants for tests and procedures (e.g., laboratory tests, X-rays, and other protocol-specific studies) and retrieves and submits results to appropriate parties.</li><li>
Works with multiple departments to coordinate diagnostic procedures.</li><li>
Assists with site selection and site initiation visits by coordinating schedules with external monitors and internal departments.</li><li>
Collects, evaluates, enters, and tracks research data.</li><li>
Collects research patient information (e.g., medical history, lab results) from the electronic medical record (EMR).</li><li>
Maintains accurate source documentation and CRFs in compliance with study protocols.</li><li>
Reviews research orders in Epic/Beacon with providers to ensure accuracy and completeness.</li></ul><p></p><p><b>
Submits data, study documents, and/or reports to regulatory agencies</b></p><ul><li>
Submits accurate research data via CRFs to external entities in a timely manner.</li><li>
Provides prompt and appropriate responses to sponsor data requests or queries.</li></ul><p></p><p><b>
Assists with completion of protocol-specific documents</b></p><ul><li>
Monitors protocol compliance and communicates deviations, errors, or incomplete documentation appropriately.</li></ul><p></p><p><b>
Establishes study files and prepares study-related documentation</b></p><ul><li>
Creates and maintains research charts.</li><li>
Updates internal and external databases in accordance with departmental, sponsor, and study requirements.</li></ul><p></p><p><b>
Collects samples from participants</b></p><ul><li>
Collects, processes, ships, and maintains documentation for blood and/or biological specimens according to study protocols and standard operating procedures (SOPs).</li></ul><p></p><p><b>
Performs other job-related duties as assigned</b></p><ul><li>
May order supplies and equipment.</li><li>
May perform neurocognitive testing.</li><li>
Seeks guidance from the Clinical Research Manager for additional assignments.</li></ul><p></p><h3 class="jobSectionHeader"><b>
% of Time Spent on Duties</b></h3><ul><li>
30% &ndash; Informed consent and patient recruitment</li><li>
20% &ndash; Biological sample management</li><li>
20% &ndash; Data abstraction</li><li>
15% &ndash; Data management and query resolution</li><li>
10% &ndash; Research document completion (e.g., CRFs, study logs, internal reports)</li><li>
5% &ndash; Research chart organization</li></ul></div><ul><li>
Performs other job duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.</li><li>
One year of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Requires effective verbal and written communication skills.</li><li>
Requires proficiency with computers, internet and Microsoft Office applications.</li><li>
May require experience with computer spreadsheets and database management.</li><li>
May require the ability to understand and implement patient studies and protocols.</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div>

Research Coordinator II - Pediatrics - Hematology & Oncology Clinical Research

Beacon Clinic

<div><p>Why Join Us?</p><p></p><p>
Beacon Clinic was founded for the purpose of delivering a level of care that we, as a team, can all be proud of. We are a patient-focused health and wellness clinic that is committed to providing the highest quality of medical care and supportive services. When founded, we specialized in the treatment of cancer and blood conditions. Today, we provide medical oncology and hematology, radiation oncology, rheumatology, and urology services to our phenomenal patients. Learn more about us at our website.</p><p></p><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><b>
Job Description:</b></p></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div><p>
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Principal Investigator (PI) and VP of Clinical Operations on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.</p></div><p></p><div><p><br>
The CRC works collaboratively with the entire Beacon Clinic team, sponsors, and sponsor monitors to ensure compliance with the protocol, ensuring participant is receiving quality and safe care, along with productive and timely data submissions.</p></div><p></p><p><b>
Duties/Responsibilities:</b></p><ul><li><p>
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) by way of reviewing and acknowledging all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities while utilizing good clinical practice.
</p></li></ul><p></p><ul><li><p>Coordinates participant care throughout the research protocol continuum to include, but not limited to prescreening and screening for eligibility, confirming eligibility prior to randomization, consenting, coordination of all necessary protocol procedures and seeking problem resolutions as necessary.</p></li></ul><p></p><ul><li><p>
Develops and implements accurate source materials and ensures compliance from all applicable site staff.</p></li></ul><p></p><ul><li><p>
Provides accurate and timely data collection documentation, data entry, and reporting in both Beacon&rsquo;s EMR and sponsors applicable databases.</p></li></ul><p></p><ul><li><p>
Reports serious adverse events within 24 hours from site awareness of the event in the applicable data system.</p></li></ul><p></p><ul><li><p>
Confirms appropriate credentialing and trainings are complete and current for accurate data capture regarding all study materials such as protocols, participants questionnaires, electronica data capture systems, collection, storage and shipment of specimens, and drug accountability per delegation of responsibility log.</p></li></ul><p></p><ul><li><p>
Supports the regulatory staff in the maintenance of regulatory documents, standard operating procedures, and applicable regulations.</p></li></ul><p></p><ul><li><p>
Communicates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.</p></li></ul><p></p><ul><li><p>
Participates with principal investigator and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.</p></li></ul><p></p><ul><li><p>
Monitors research participants to ensure visits are appropriately scheduled and include all necessary components.</p></li></ul><p></p><ul><li><p>
Updates research calendar and date spreadsheet to ensure it can be used as an accurate communication tool amongst the research team as well as advising when assistance is needed to meet deadlines per contract, compliance, and sponsors/CRO/monitors requests.</p></li></ul><p></p><ul><li><p>
Carries out daily operations that contribute to the success of Beacon&rsquo;s mission to provide an unparalleled patient experience.</p></li></ul><p></p><ul><li><p>
Performs Medical Assistant duties as needed, including, rooming patients and preparing them for study visits, obtaining and documenting vital signs, height, weight, and medical history updates, assisting providers with exams and procedures per protocol and clinic standards, performing phlebotomy, specimen collection, processing, storage, and shipment per protocol requirements, administering medications and/or injections as delegated and permitted by scope and protocol.</p></li></ul><p></p><p><b>
Required Skills/Abilities:</b></p><div><ul><li><p>
Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts.</p></li></ul></div><div><ul><li><p>
Detail-oriented and meticulous in all aspects of work with the ability to be flexible, organized, detail-oriented and tenacious in follow-through.</p></li></ul></div><p></p><div><ul><li><p>
Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.</p></li></ul></div><p></p><div><ul><li><p>
Must have professional demeanor and strong communication skills with the public as well as physicians and researchers.</p></li></ul></div><p></p><div><ul><li><p>
Ability to work well independently as well as in a team environment.</p></li></ul></div><p></p><div><ul><li><p>
Must be proficient in Microsoft Office, electronic health systems and databases used in a research environment or have a willingness to learn and demonstrate proficiency within six months of hire.</p></li></ul></div><p></p><div><ul><li><p>
Possess the ability to work well under pressure, multi-task and manage deadlines.</p></li></ul></div><p></p><div><p><b>
Preferred Qualifications:</b></p></div><div><ul><li><p>
Certification as a Medical Assistant (CMA, RMA, or equivalent) preferred</p></li></ul></div><div><ul><li><p>
Experience in clinical research or healthcare setting preferred</p></li></ul></div><div><ul><li><p>
Phlebotomy experience required or strongly preferred</p></li></ul></div><div><ul><li><p>
Knowledge of Good Clinical Practice (GCP) guidelines</p></li></ul></div><div><ul><li><p>
Strong organizational, communication, and patient care skills</p></li></ul></div><p></p><p><b>
Location:</b></p><ul><li><p>
May be asked to work at both locations</p></li><li><p>
3815 N Schreiber Way, Suite 101, Coeur d'Alene, ID 83815</p></li><li><p>
1641 E Polston Avenue, Suite 102, Post Falls, ID 83854</p></li></ul><p></p><p><b>
Benefits:</b></p><ul><li><p>
Generous Paid Time Off</p></li><li><p>
8 paid, closed-clinic holidays</p></li><li><p>
Health Insurance, including dental and vision</p></li><li><p>
401(k) Plan</p></li><li><p>
Gym membership</p></li><li><p>
Professional Development Fund</p></li></ul><p></p><p><b>
Beacon Company Mission:</b> To meet patients wherever they are on their cancer journey and walk with them on that journey; to provide compassionate, personalized cancer care for an unparalleled patient experience.</p><p></p><p><b>
Beacon Core Values: </b>Compassion. Grace. Honesty. Humor. Respect. Trust.</p><p></p><p>
Our providers and staff at Beacon share these values and truly embody the mission of Beacon. Our team is comprised of the most devoted, compassionate individuals who consistently go above and beyond for patients and who strive to continually improve patient care and the overall patient experience.</p></div>

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