Coordinates clinical and administrative aspects of sponsored clinical trials, including subject recruitment, enrollment, and data collection. Acts as the primary liaison between sponsors and investigators while ensuring protocol adherence and regulatory compliance.
Requirements summary
Requires a Bachelor's degree in Biology, Health Science, Nursing, or a related field and typically 2 years of research experience. Knowledge of GCP, ICH, and FDA regulations is essential, along with proficiency in EMR systems.
Information: RN Preferred Generally Monday-Friday, business hours Pay Range $30.70 - $46.05
Major
Responsibilities: Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies, as applicable. Provides guidance to physicians, clinical staff and research team members. Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to; study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits. Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff. Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff. Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows. Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens. Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites. Coaches and mentors research team members and other personnel. Assist with implementation of educational training plans including orientation. Maintains competency in research computer applications Attends and participates in educational programs, meetings, and assigned committees. Licensed nurses will utilize advanced assessment skills to identify patient care problems, provide professional nursing care to research patients and support Research Coordinators in performing nursing activities as needed.
Licensure,
Benefits
Dental Insurance
Life Insurance
Paid Parental Leave
Paid Time Off
Vision Insurance
Medical Insurance
Short-Term Disability
Long-Term Disability
Flexible Spending Accounts
Adoption Assistance
Educational Assistance Program
Retirement Plans With Employer Match
Registration, and/or
Certification
Required: None Required.
Education
Required: Bachelor's Degree in Biology, or Bachelor's Degree in Health Science, or Bachelor's Degree (or equivalent knowledge) in Nursing or related field.
Experience
Required: Typically requires 2 years of experience in Research.
Knowledge,
Skills &
Abilities
Required: Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures. Ability to successfully conduct and manage a research study. Ability to mentor team members and to prepare training plans. Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree of accuracy and attention to detail. Must be able to establish a good rapport with patients, investigators and sponsors. Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs
Physical
Requirements and
Working
Conditions: Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift. Must have functional sight and hearing. Ability to function in a latex environment. May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary. Exposed to a normal office environment. Operates all equipment necessary to perform the job. Position may require travel among sites and therefore there is exposure to road and weather conditions. This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.
Our
Commitment to
You:
Advocate
Health offers a comprehensive suite of
Total
Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs
Educational
Assistance
Program
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview. About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits. This is Transformation One shared purpose brought us together. Now, as one of the 10 largest not-for-profit, integrated health systems in the United States, our combined strength and stability drives us forward. Starting with You Caring for nearly 3 million people has inspired a transformation. One in which the patient’s experience guides our vision and empowers us to offer new possibilities in our communities. Reshaping Access What is access? It’s offering more sites of care than any other health system in the Midwest. But there’s a new frontier. Access is exploring the latest technologies to deliver care to patients exactly where they are and exactly when they need it Inspiring Professionals With our dynamically inclusive workforce and strong connections to the places where we live and work, we’ll touch more lives and contribute to stronger and more vibrant communities. Transforming Care We’re redefining the standard for care with world-class doctors and caregivers, innovative solutions, outstanding outcomes, and leading-edge research and clinical trials.
Combined,
Advocate and
Aurora are recognized for clinical excellence in: Cardiovascular Care Neurosciences Gynecology Oncology Pediatrics Primary Care Neurology Geriatrics Trauma Care
