clinical pharmacist

clinical research coordinator Jobs in Miami

clinical research coordinator

clinical research coordinator 2 Jobs in Miami

clinical research coordinator 2

clinical research data assistant Jobs in Miami

clinical research data assistant

clinical informatics specialist

Nicklaus Children's Health System

<div>
 
 Description
 
 
 
 
 Job Summary
 
 
 
 Assumes responsibility in association with Physicians and Leaders to serve as a liaison for the "community" (referring physicians, patients and families) and other MCH Physicians. Assesses, plans, implements, evaluates, and supervises individual patient care according to organizational policies and procedures. Establishes early contact with first year cancer patients to eliminate barriers to timely diagnosis and treatment by coordination of referrals from physicians and health care facilities. Providing a significant level of patient education related to illness and planned treatment. Providing patients with resources and linkages including community and patient/family support and assisting in meeting cancer-related needs as identified by patients and families.
 
 
 
 Job Specific Duties
 
 
 
 <ul>
 <li>
 Ensures safe and efficient patient care. Works closely with physicians in all specialty areas to coordinate and communicate the patient&rsquo;s care plan.
 </li>
 <li>
 Ensures further development of a collaborative and streamlined transitional patient and family process and physicians in the community and/or other related services.
 </li>
 <li>
 Works and collaborates with multidisciplinary teams to maintain and implement up-to-date coordinated patient care; communicates with all members of the healthcare team on behalf of the patient.
 </li>
 <li>
 Ensures clinical protocols to refer patients to appropriate specialist for diagnosis and treatment. Assists patients/families in obtaining referrals/appointments with needed specialists.
 </li>
 <li>
 Collaborates w/ multi-disciplinary team to provide support as appropriate to the clinical situation.
 </li>
 <li>
 Identifies and eliminates health care system barriers to ensure timely access to quality medical and clinical care.
 </li>
 <li>
 Proactively develops &amp; enhances clinical processes with the goal of providing an excellent quality clinical experience for patients. Assures smooth transition of inpatient/outpatient experiences.
 </li>
 <li>
 Communicates with referring physician&rsquo;s office for the patient&rsquo;s and physician&rsquo;s needs. Serves as liaison to community organizations for ongoing information and support services.
 </li>
 <li>
 Identifies, informs &amp; educate patients about their disease. Provides educational &amp; materials to parents. Develops care plans to enhance education &amp; satisfaction; addresses clinical concerns.
 </li>
 <li>
 Works with Marketing and outreach departments to educate referring physicians and facilities on available services.
 </li>
 <li>
 Collaborates in the screening and referral of patients for eligibility for research clinical trials.
 </li>
 <li>
 Serves as a nurse liaison to facilitate services on patient management and leads in the coordination of complex care across a continuum of care from admission and procedure through outpatient follow-up.
 </li>
 <li>
 Ensures communication between staff &amp; physicians; responsible for arranging appointments &amp; follow-up; serve as a front-line resource to obtain records, test results, &amp; other clinical information.
 </li>
 <li>
 Functions as clinical expert/role model for the Pediatric Oncology Department, identifying clinical and communication issues.
 </li>
 <li>
 Utilizes data obtained to integrate evidence practice into patient care processes.
 </li>
 <li>
 Along with administrative staff, keeps meticulous data of physician and patient inquiries, including outcomes related to timeliness of communication, completed referrals and outcomes.
 </li>
 <li>
 Disseminates new information across the institution and the community, and remains current and at the cutting edge of specialty.
 </li>
 <li>
 Promotes a safe &ldquo;error free&rdquo; working environment by consistently performing thorough hand-offs, supporting infection prevention, and other patient safety measures.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 Minimum Job Requirements
 
 
 
 <ul>
 <li>
 Bachelor's Degree in Nursing - BSN degree or currently enrolled in accredited BSN program with expected graduation date within 6 months of hire date
 </li>
 <li>
 American Heart Association BLS - maintain active and in good standing throughout employment
 </li>
 <li>
 RN Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) &ndash; maintain active and in good standing throughout employment
 </li>
 <li>
 2-4 years of experience in oncology nursing
 
 
 </li>
 </ul>
 
 Knowledge, Skills, And Abilities
 
 
 
 <ul>
 <li>
 Master&rsquo;s degree in Nursing preferred.
 </li>
 <li>
 Specialty certification is preferred.
 </li>
 <li>
 Pediatric nursing in an acute care setting preferred.
 </li>
 <li>
 Strong interpersonal communication skills.
 </li>
 <li>
 Ability to communicate effectively both verbally and in writing.
 </li>
 <li>
 Well versed in conflict management skills.
 </li>
 <li>
 Good analytical and deduction skills.
 </li>
 <li>
 Sympathetic and emotionally supportive to patients and families.
 </li>
 <li>
 Strong organizational skills.
 </li>
 <li>
 Able to multi-task.
 
 
 </li>
 </ul>
 
 Job
 
 
 
 Nursing - Clinical
 
 
 
 Department
 
 
 
 NURSING PROFESSIONAL PRACTICE-2100-860010
 
 
 
 Job Status
 
 
 
 Professional
</div>

Nurse Navigator- Pediatric Oncology (Full Time, Days)

Mount Sinai Medical Center

<div>As Mount Sinai grows, so does our legacy in high-quality health care.
Since 1949, Mount Sinai Medical Center has remained committed to providing access to its diverse community. In delivering an unmatched level of clinical expertise, our medical center is committed to recruiting and training top healthcare workers from across the country. We offer the latest in advanced medicine, technology, and comfort in 12 facilities across Miami-Dade (including our 674-bed main campus facility) and Monroe Counties, with 38 medical services, including cancer care, 24/7 emergency care, orthopedics, cardiovascular care, and more. Mount Sinai takes pride in being South Florida's largest private independent not-for-profit hospital, dedicated to continuing the training of the next generation of medical pioneers.
Culture of Caring: The Sinai Way
Our hardworking, tight-knit community of more than 4,000 dedicated employees fosters an environment of care and compassion. Each member plays a vital role in our collective mission to deliver excellent healthcare through innovation, education, and research. At Mount Sinai, we take pride in our achievements, aiming to be a beacon of quality healthcare in South Florida. We welcome all healthcare professionals to join our thriving community and contribute to our pursuit for clinical excellence.
Department:
CC019980 Research Admin Payroll Control
Job Description Summary:
The Urology Research Registry Abstractor is responsible for reviewing patient medical records to extract, code, analyze, and enter detailed urologic clinical data into institutional, state, and national research and quality registries. This role supports clinical outcomes research, quality improvement initiatives, resident and fellow education, grant-funded research projects, and regulatory reporting within the Department of Urology. Proficiency with redcap software and database management.
Position Responsibilities<ul><li>
Performs the screening of participant patients, following the assigned research requirements and protocol.</li><li>
Proficiency with REDCap software and database management.</li><li>
Review inpatient and outpatient medical records for urologic conditions, including but not limited to:<ul><li>
Prostate, bladder, kidney, and testicular cancers</li><li>
Benign prostatic hyperplasia (BPH)</li><li>
Nephrolithiasis (kidney stones)</li><li>
Reconstructive urology procedures</li><li>
Robotic and minimally invasive surgical procedures</li></ul></li><li>
Abstract and code diagnoses, procedures, pathology findings, cancer staging, biomarkers, complications, treatments, recurrence data, and clinical outcomes.</li><li>
Enter, validate, and maintain high-quality data in institutional databases and specialty registries.</li><li>
Perform case finding through pathology reports, operative reports, clinic schedules, tumor boards, and EHR reporting tools.</li><li>
Conduct regular data audits ensuring completeness and accuracy.</li><li>
Ensure compliance with registry standards, accreditation requirements, research protocols, and reporting deadlines.</li><li>
Assist faculty, fellows, residents, and medical students with retrospective chart reviews and research dataset preparation.</li><li>
Generate datasets for abstracts, manuscripts, presentations, quality improvement projects, and grant submissions.</li><li>
Participate in departmental research meetings, tumor boards, and quality improvement committees as needed.</li><li>
Support preparation of reports for internal review, institutional benchmarking, and national comparisons.</li><li>
Assist with preparation and submission of IRB applications, amendments, continuing reviews, and study closures.</li><li>
Maintain study documentation, regulatory binders, and research files in accordance with institutional and federal guidelines.</li><li>
Ensure all data abstraction activities align with approved IRB protocols.</li></ul>
Qualifications<ul><li>
License/Registration/Certification<ul><li>
Preferred: RHIT (Registered Health Information Technician), RHIA (Registered Health Information Administrator), CCS (Certified Coding Specialist), CPC (Certified Professional Coder), or Active CITI Program certification in Human Subjects Research.</li></ul></li><li>
Education<ul><li>
Bachelor&rsquo;s degree in Health Information Management, Nursing, Public Health, Clinical Sciences, or related field required.</li></ul></li><li>
Experience<ul><li>
2+ years of clinical data abstraction, registry management, coding, or clinical research experience required.</li><li>
Experience in surgical, oncology, or urology preferred.</li><li>
Experience in an academic medical center or teaching hospital preferred.</li><li>
Experience working with IRB protocols and regulatory documentation preferred.</li></ul></li></ul>
Benefits:
We believe in the physical and mental well-being of our employees and are committed to offering comprehensive benefits that fit their personal needs:<ul><li>
Health benefits</li><li>
Life insurance</li><li>
Long-term disability coverage</li><li>
Healthcare spending accounts</li><li>
Retirement plan</li><li>
Paid time off</li><li>
Pet Insurance</li><li>
Tuition reimbursement</li><li>
Employee assistance program</li><li>
Wellness program</li><li>
On-site housing for select positions and more!</li></ul>
Degree Requirements:
Certification:</div>

Research Registry Abstractor Urology

The START Center for Cancer Research

<div>The START Center for Cancer Research (&ldquo;START&rdquo;) is the world&rsquo;s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. 


The START Center for Cancer Research is seeking a Director of Nursing &amp; Study Operations. The Director of Nursing &amp; Study Operations is a dual-function leadership role responsible for the oversight and performance of START&rsquo;s nursing teams and clinical research operations. This role ensures compliant, efficient, and high-quality care and study conduct across departments, while supporting START&rsquo;s goals for study growth, operational excellence, and patient care. The Director leads Clinical Research Coordinators, Medical Records, Data Coordinators, Clinic Nurses, Infusion Nurses, Nurse Navigators, Referral Intake and Scheduling teams. The position works collaboratively across departments including Quality, Regulatory, Finance, and Site Development. 
Work Schedule: 
Monday-Friday 8:00am-5:00pm 
Essential Responsibilities

Leadership &amp; Oversight
<ul>
<li>Provide effective, proactive leadership to Clinical Research Coordinators, Data Coordinators, Medical Records staff, Clinic Nurses, Infusion Nurses, Nurse Navigators, Referral Intake and Schedulers.</li>
</ul><ul><li>Provide training, coaching, and development for direct reports, ensuring ongoing competency and alignment with START&rsquo;s values and expectations.</li>
</ul><ul><li>Promote high-quality, patient-centered care and research delivery across clinical and study workflows.</li></ul> 


Operational Management
<ul>
<li>Oversee processes for referral intake, scheduling, patient navigation, study startup, and protocol feasibility.</li>
<li>Supervise implementation of CTMS, EHR, and other clinical documentation systems.</li>
<li>Ensure accurate and timely data capture, monitor engagement, and audit preparedness across departments.</li>
<li>Oversee use of effective workflows and SOPs; lead ongoing review and revision efforts.</li></ul> 


Clinical &amp; Study Collaboration
<ul>
<li>Serve as clinical and operational liaison to investigators, quality team, regulatory, pharmacy, and global shared services.</li>
<li>Partner with leaders to ensure compliant delivery of care within the scope of research protocols.</li>
<li>Support review and feasibility assessment of new protocols with attention to nursing and operational capacity.</li>
<li>Ensure equitable study allocation and ongoing support for study teams.</li></ul> 


Process Improvement &amp; Strategic Support
<ul>
<li>Use continuous improvement techniques to streamline workflows and resolve care or operational bottlenecks.</li>
<li>Track key metrics across referrals, screening, enrollment, and patient satisfaction.</li>
<li>Participate in strategic initiatives and regional projects to expand access and improve operational performance.</li>
<li>Collaborate with quality and compliance teams to uphold all applicable federal, GCP, and GDPR regulations.</li>
<li>Other duties may be assigned at any time.</li></ul> 


Required Education and Experience:
<ul>
<li>Bachelor&rsquo;s degree in Nursing or Health-related field</li>
<li>RN license in good standing with state</li>
<li>Minimum 5 years of leadership experience in oncology clinical research</li>
<li>CITI GCP training</li>
<li>Strong working knowledge of federal clinical research regulations, GCP, and GDPR</li>
<li>Familiarity with Microsoft Office applications and EHR/CTMS systems</li></ul> 


Preferred Education and Experience:
<ul>
<li>Advanced degree (MSN, MHA, MBA, or related)</li>
<li>ONS/ONCC chemotherapy immunotherapy certificate</li>
<li>Oncology Certified Nurse (OCN)</li></ul> 


Physical &amp; Travel Requirements:
<ul>
<li>Approximately 80% of time is spent sitting</li>
<li>Very fast-paced and ever-changing healthcare environment</li>
<li>Demanding deadlines and constant knowledge updates required</li>
<li>Works closely with physicians and cross-functional teams</li>
<li>Intermittent travel to support site activation and training (&lt;10%)</li></ul> 


Best-in-Class Benefits and Perks

We value our employees&rsquo; time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:
<ul>
<li>Comprehensive health coverage: Medical, dental, and vision insurance provided</li>
<li>Robust retirement planning: 401(k) plan available with employer matching</li>
<li>Financial security: Life and disability insurance for added protection</li>
<li>Flexible financial options: Health savings and flexible spending accounts offered</li>
<li>Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided</li>
<li>Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.</li></ul> 


More about The START Center for Cancer Research

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world&rsquo;s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. 


Learn more at STARTresearch.com. 


Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. 


We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.</div>

Director of Nursing & Study Operations

NUTRIMED INTERNATIONAL LLC

<h2>Position Overview</h2>The Order Entry &amp; Coordination Specialist is responsible for accurately processing customer orders, coordinating internal teams, and ensuring smooth order fulfillment from initial request through delivery. This role requires strong attention to detail, excellent organizational skills, and the ability to communicate effectively with customers, vendors, sales teams, and operations departments.<h2>Key Responsibilities</h2><ul><li>Enter and process customer orders accurately into company systems and databases.</li><li>Review purchase orders, customer requests, pricing details, and product information for accuracy.</li><li>Coordinate order activities between sales, warehouse, logistics, purchasing, and customer service teams.</li><li>Monitor order status and provide timely updates to customers and internal stakeholders.</li><li>Resolve order discrepancies, delays, or issues while maintaining excellent customer service.</li><li>Maintain accurate records of orders, invoices, shipping details, and customer information.</li><li>Assist with inventory availability checks and coordinate product fulfillment.</li><li>Prepare order reports and track key performance metrics.</li><li>Communicate with vendors and suppliers regarding order confirmations and delivery schedules.</li><li>Support administrative tasks related to order management and operational coordination.</li><li>Ensure compliance with company policies and quality standards throughout the order process.</li></ul><h2>Qualifications</h2><ul><li>High school diploma or equivalent required; associate or bachelor’s degree preferred.</li><li>1–3 years of experience in order entry, customer service, administration, logistics, or operations support.</li><li>Strong data entry skills with excellent accuracy and attention to detail.</li><li>Proficiency with Microsoft Office Suite (Excel, Word, Outlook) and order management systems.</li><li>Excellent written and verbal communication skills.</li><li>Ability to multitask, prioritize workloads, and meet deadlines in a fast-paced environment.</li><li>Strong problem-solving skills and a customer-focused mindset.</li><li>Ability to work independently and collaborate effectively with teams.</li></ul><h2>Preferred Skills</h2><ul><li>Experience with ERP, CRM, or inventory management software.</li><li>Knowledge of supply chain, shipping, or fulfillment processes.</li><li>Strong organizational and documentation skills.</li><li>Ability to identify process improvements and support operational efficiency.</li></ul><h2>Work Environment</h2>This position may be available as a remote, hybrid, or onsite role depending on company needs. The specialist will collaborate with multiple departments to ensure accurate and timely order processing while delivering a positive customer experience.<h2>Core Competencies</h2><ul><li>Order Management</li><li>Data Accuracy</li><li>Customer Service</li><li>Communication</li><li>Organization &amp; Time Management</li><li>Problem Solving</li><li>Team Collaboration</li><li>Process Improvement</li></ul>

Order Entry & Coordination Specialist

Harbor Group Management

Harbor Group Management Company is a multi-billion dollar real estate investment and property management firm. As we continue to grow, we are looking for passionate, goal oriented, creative individuals with an entrepreneurial spirit and great communication skills. Harbor Group is dedicated to outstanding customer service and providing exquisite living experience for our residents.
 
Leasing Specialist
 
Job Title: Leasing Specialist
 Division: Multifamily
 Status: Non-Exempt
 
JOB SUMMARY: The Leasing Specialist is responsible for driving occupancy and resident satisfaction in a multi-family community. This role includes showing and leasing apartments to prospective residents, coordinating marketing initiatives, assisting in resident retention efforts, and supporting the Property Manager in daily operations to ensure a positive living experience and strong financial performance.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following but are not limited to the job specifications contained herein. Additional duties or job functions that can be performed safely may be required as deemed necessary by Harbor Group Management Company.
 
<ul>
<li>Greet prospective residents, conduct property tours, and showcase available apartments and amenities.</li>
<li>Qualify leads, process rental applications, run background and credit checks, and prepare lease documents.</li>
<li>Ensure units are move-in ready by inspecting them before occupancy and coordinating outstanding items with maintenance.</li>
<li>Execute lease agreements and move-in packages, ensuring a smooth onboarding process for new residents.</li>
<li>Design and implement short- and long-term marketing plans to generate traffic and maintain occupancy.</li>
<li>Promote the community via digital platforms such as Craigslist, Facebook, and email campaigns.</li>
<li>Coordinate resident referral programs, employer outreach, and participate in local networking efforts.</li>
<li>Maintain up-to-date knowledge of market conditions, competitor properties, rental rates, and trends.</li>
<li>Support resident retention through excellent customer service and timely response to questions, complaints, and maintenance needs.</li>
<li>Conduct follow-up communication with prospects and new residents to ensure satisfaction.</li>
<li>Participate in lease renewal efforts by preparing renewal documents, engaging with residents, and finalizing lease extensions.</li>
<li>Maintain accurate records of prospect and resident interactions using property management software (e.g., Yardi, OneSite).</li>
<li>Keep guest cards updated and perform follow-ups on all leads.</li>
<li>Assist with rent collection, manage delinquent accounts, and support administrative tasks as assigned by the Property Manager.</li>
<li>Ensure leasing office and tour path are presentable and meet show standards at all times.</li>
</ul>
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
 <ul>
<li>High School Diploma or equivalent.</li>
<li>Minimum one year of experience in leasing, sales, or customer service; property management experience preferred.</li>
<li>Proficient with Microsoft Office and Property Management software experience is a must.</li>
<li>Experience utilizing social media (Facebook, Instagram, etc.) is preferred.</li>
<li>Excellent organizational and communication skills with the ability to manage multiple tasks and deadlines in a fast-paced environment.</li>
<li>Strong attention to detail, problem-solving skills, and the ability to work independently or as part of a team.</li>
<li>Must be customer-service oriented with the ability to interact professionally with residents and vendors.</li>
<li>Flexibility to work weekends if required by the property.</li>
<li>Valid driver’s license required (for operating golf carts if applicable).</li>
</ul>
#LI-ED2
 
WHAT WE OFFER: 
<ul>
<li>Competitive Salaries & Bonuses</li>
<li>Medical, Dental & Vision Plans</li>
<li>401(k) Plan with Employer Matching Contributions</li>
<li>Paid Time Off (PTO) & 10+ Paid Holidays</li>
<li>Paid Parental Leave</li>
<li>Paid Birthday Off (Multifamily)</li>
<li>Flexible Spending Accounts</li>
<li>Company-Paid Long-Term Disability</li>
<li>Company-Paid Life Insurance</li>
<li>Short-Term Disability</li>
<li>Health Savings Account with Employer Contributions</li>
<li>Pre-Tax Commuter Benefit (Corporate)</li>
<li>Wellness Perks</li>
<li>FinFit Financial Wellness Program</li>
<li>Legal Resources</li>
<li>Employee Apartment Discount</li>
<li>Employee Referral Program</li>
<li>Employee Assistance Program</li>
<li>Tuition Reimbursement</li>
<li>Insta Pay Eligible</li>
<li>Volunteer & Community Service Opportunities</li>
<li>Employee Recognition & Awards</li>
</ul>
Benefit eligibility will be determined at the time of hire. Eligibility for certain benefits may vary based on position, location, hours worked, and other qualifying criteria.
 
Veteran Friendly
 This pre-employment application will be given every consideration, but its receipt does not imply that the applicant will be employed. Each question should be answered in a complete and accurate manner as no action can be taken on this application until all questions have been answered.
 Harbor Group Management is proudly an Equal Opportunity Employer EOE/M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Leasing Specialist

Cardiovascular Associates of America

<div>Clinical Research Data Assistant 
This will be an in-person position in South Miami, Florida
Position Summary
The Clinical Research Data Assistant provides administrative, data management, and study support services for clinical research studies. This position is responsible for sponsor system data entry, study reporting, document management, regulatory support, and research communications.
The Clinical Research Data Assistant works closely with Clinical Research Coordinators, investigators, sponsors, and the regulatory team to ensure accurate, timely, and compliant study documentation and reporting.
Essential Responsibilities
Data Management<ul><li>Enter study data into sponsor electronic data capture (EDC) systems.</li><li>Transcribe source documentation into sponsor systems accurately and timely.</li><li>Review entered data for completeness and accuracy.</li><li>Resolve basic data discrepancies and escalate complex issues.</li><li>Maintain study tracking logs and databases.</li></ul>
Sponsor Systems Management<ul><li>Maintain user access and system tracking documentation.</li><li>Upload required documents into sponsor portals.</li><li>Monitor sponsor system notifications and alerts.</li><li>Support completion of sponsor-required documentation.</li></ul>
Screening, Enrollment, and Study Reporting<ul><li>Prepare routine reports on screening, enrollment, randomization, and retention metrics.</li><li>Track recruitment and enrollment performance.</li><li>Maintain study enrollment dashboards and tracking tools.</li><li>Generate reports for site leadership and study teams.</li></ul>
Regulatory and Document Support<ul><li>Route study documents for review and signature.</li><li>Assist with collection of regulatory documents.</li><li>Maintain electronic and paper study files.</li><li>Support regulatory filing activities.</li><li>Assist with investigator and staff training documentation.</li></ul>
Communication Management<ul><li>Manage study email inboxes.</li><li>Route sponsor communications to appropriate team members.</li><li>Track action items from sponsor correspondence.</li><li>Assist with scheduling sponsor meetings and study-related calls.</li></ul>
Coordinator and Site Support<ul><li>Provide administrative support to Clinical Research Coordinators and investigators.</li><li>Assist with study start-up documentation.</li><li>Support study close-out activities.</li><li>Assist with preparation for sponsor monitoring visits, audits, and inspections.</li></ul>
Quality and Compliance<ul><li>Maintain confidentiality of participant information.</li><li>Ensure data accuracy and completeness.</li><li>Follow Good Clinical Practice (GCP), sponsor requirements, and site SOPs.</li><li>Participate in quality improvement initiatives.</li></ul>
Qualifications
Education<ul><li>High School Diploma required.</li><li>Associate's degree or Bachelor's degree preferred.</li></ul>
Experience<ul><li>Previous healthcare, data entry, administrative, research, or regulatory experience preferred.</li><li>Experience with electronic systems and databases preferred.</li></ul>
Knowledge, Skills, and Abilities<ul><li>Exceptional attention to detail.</li><li>Strong data entry and computer skills.</li><li>Strong written and verbal communication skills.</li><li>Ability to manage multiple deadlines.</li><li>Strong organizational skills.</li><li>Proficiency in Microsoft Office applications, particularly Excel.</li><li>Ability to learn sponsor systems, CTMS, eSource, and eRegulatory platforms.</li></ul>
Physical Requirements<ul><li>Ability to perform prolonged computer-based work.</li><li>Ability to review detailed documentation for extended periods.</li><li>Ability to occasionally lift and move files or supplies up to 15 pounds.</li></ul> 

GHHwR9Xt8Y</div>

Clinical Research Data Assistant

Evolution Research Group

<div>
 
 
 
 About Company:
 
 
 
 
 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. &nbsp;ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
 
 
 
 
 Why join us?
 
 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.&nbsp;
 
 
 
 
 Job Description:
 
 
 
 
 The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC 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.
 
 
 
 
 Responsibilities:
 
 
 
 
 
 General
 
 
 
 <ul>
 
 <li>
 Obtain&nbsp;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>
 Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
 </li>
 
 <li>
 Review&nbsp;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&nbsp;studies with direct oversight from Site Director, 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.&nbsp;
 </li>
 
 <li>
 Contribute to the SOP review and development as delegated by the Site Director.&nbsp;
 </li>
 
 </ul>
 
 
 
 Study Management
 
 &nbsp;
 
 
 <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 with directive from Site Director.&nbsp;
 </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 with potential study volunteer
 </li>
 
 <li>
 Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
 </li>
 
 <li>
 Maintain organized, accurate and complete study records
 </li>
 
 <li>
 Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
 </li>
 
 <li>
 Enter data as appropriate for protocol (paper-electronic data capture)
 </li>
 
 <li>
 In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
 </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>
 
 
 
 Skills and Qualifications:
 
 
 
 <ul>
 
 <li>
 
 Education and experience
 
 
 <ul>
 
 <li>
 High School Diploma or its equivalent; College degree preferred.
 </li>
 
 <li>
 Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.&nbsp;
 </li>
 
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 Knowledgeable in medical terminology to communicate with physician office and laboratory staff.&nbsp;
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 Demonstrate&nbsp;the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
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 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.
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 Requirements
 
 
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 Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.&nbsp;
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 Excellent communication skills (interpersonal, written, verbal)&nbsp;
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 Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
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Clinical Research Coordinator

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