Senior Clinical Trials Study Startup Coordinator

Department:

80028 Research - Clinical Trials: Oncology

Status:

Full time

Benefits Eligible:

Yes

Hou rs Per Week:

40

Schedule Details/Additional Information:

Full time role. Remote work with in-person presence (e.g., site visits, recruitment activities, meetings) as needed.

MAJOR RESPONSIBILITIES

• Efficiently and effectively manage successful execution of clinical trial start-up through activation / clinical trial launch.
• Establish, develop, track and deliver study pipeline and study specific activation plans.
• Lead the site activation team working the appropriate teammates to help implement activities on the study specific activation plans. Liaise with internal operations, physicians and industry/clinical research leaders.
• Partner with cross-functional teammates internally and externally to improve overall study startup metrics and implement processes.
• Help teams identify and solution for startup barriers, escalating to leadership as appropriate.
• Assist clinical trial leadership with preparing and managing the Scientific Review Protocol Committee, Protocol Review Monitoring Committee and/or other committees as appropriate. Serve as a sponsor point of contact during the feasibility and startup process.
• Facilitate and attend site qualifications and site initiation visits. Utilize data to identify and improve the study start-up process.
• Responsible for outreach to applicable physicians, care teams, etc. to gain valuable information.
• Maintain working knowledge of clinical trials within the assigned service line research portfolio.
• Review pertinent regulations to develop proactive solutions to start up challenges.

MINIMUM EDUCATION AND EXPERIENCE REQUIRED

License/Registration/Certification Required: None Required

Education Required: Bachelor's Degree in Business, Healthcare Administration, Nursing, Science or related field.

Experience Required: Must have 5 years of clinical research experience to include detailed understanding of clinical trial startup process of clinical research studies at a sponsor, CRO or research site. Project management experience and demonstrated role in relationship management. Experience in a team environment.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED

• Working knowledge of clinical trial management systems and electronic medical records. Familiar with federal, state, and local laws.
• Expert level proficiency in Microsoft Office, Microsoft Teams, Visio or other project management tools.
• Detailed understanding of clinical trial process across Phase II-IV and ICH GCP.
• Excellent written and verbal communication skills. Quality-focused and effective problem-solving skills.
• Excellent organizational and time management skills as well as great attention to detail.
• Ability to prioritize in a fast-paced, rapidly changing environment.
• Demonstrated ability to work independently as well as part of a team. Ability to influence and work through others.

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

• Exposed to a normal office environment.
• Operates all equipment necessary to perform the job.
• Will generally be exposed to rapid-pace and complex health care environment.
• Remote work with in-person presence (e.g., site visits, recruitment activities, meetings) as needed.
• This position may require ability to drive and/or travel to work related meetings/functions and thus is exposed to road, weather, and normal travel hazards.

This 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.

Pay Range
$37.50 - $56.25

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

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.