Senior Clinical Trials Study Startup Coordinator

Department:

80028 Research - Clinical Trials: Oncology

Status:

Full time

Benefits Eligible:

Yes

Hours 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.<