Research Activation Specialist

Astera Cancer Care; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

The Cancer & Hematology Centers is seeking a Research Activation Specialist to support study feasibility, institutional interest, and site activation. You will coordinate with sponsors, CROs, and internal teams under the Director of Research Operations to drive timely study activation.

The role requires a Bachelor’s Degree in healthcare or science, experience in clinical research study management, and knowledge of FDA regulations and GCP guidelines.

Qualifications

• Bachelor’s Degree in healthcare or science field required.
• Clinical research study management experience preferred.
• SOCRA certification a plus.

Responsibilities

• Primary contact for existing practice sites for new study opportunities.
• Oversee receipt of study documents for review with internal teams.
• Oversee timely completion of Study Feasibility for each site.
• Serve as primary contact between sponsor and sites for study activation.
• Interface with finance, billing, project management, regulatory, investigators, QA.
• Coordinate with sponsor, CRO, and vendors during activation.
• Review policies/processes for study activation and provide staff training.
• Maintain the clinical trial website.
• Communicate monthly study enrollments with outside institutions.

Skills

Communication

Study activation

Regulatory knowledge

Time management

Team orientation

Education

Bachelor’s Degree in healthcare or science

Tools

Word

Excel

PowerPoint

Zoom

Microsoft Teams

Job description

Our Mission:

At The Cancer & Hematology Centers we are dedicated to help, healing and hope for cancer patients and their families. We provide our patients with advanced treatments, innovative research and, above all else, compassionate care. Our patients receive the most comprehensive, contemporary cancer care balanced with the compassion of a dedicated nursing and support staff. Treating cancer requires a team of committed and caring health care professionals working together to understand and address your needs. In addition to caring physicians, we have a full range of support staff available to assist you and your family, such as oncology-certified nurses, social workers, experienced lab and pharmacy personnel and a psychologist. Our focus is not just on healing but also on helping and offering hope. We know that being diagnosed with cancer is a life-changing event, and it takes a lot of adjustment to accept the emotional and physical realities of this disease. Our staff understands what you’re going through and can offer compassion and resources to help. To us, it’s important that healing isn't just centered on your disease site. Our cutting-edge cancer care is available close to home. Our medical staff have close ties to prominent hospitals and ongoing cancer research, and we bring those breakthrough advances to our regional centers to progress the level of care that is offered right here at home.

Why Join Us?

We are looking for talented and high-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description: Research Activation Specialist

Position Summary: The Study Activation Coordinator is responsible for collecting study and site data feasibility, assessing institutional interest, and assisting in the determination of the appropriateness for CHC implementation. This position implements and manages study activation activities as applicable with study sponsors, CROs, and current CHC sites. This individual will work closely with the Director of Research Operations and other staff members to facilitate study selection and study activation activities supporting pharmaceutical, investigator initiated and consortia clinical trials. The Study Activation Coordinator reports directly to the Senior Director of Research Operations responsible for the study activation process.

Responsibilities

• Primary point of contact for existing practice sites for new study opportunities
• Oversee receipt of study document from sponsor/CRO for review with internal teams
• Oversight responsibility for timely completion of Study Feasibility for each site
• Serve as the primary contact for correspondence between the sponsor and sites and ensure a seamless study activation process
• Interface internally with appropriate staff in each department including finance, billing, project management, regulatory, investigators, and quality assurance.
• Serve as primary point of contact and interface externally working closely with the Sponsor, CRO, and vendors
• Institute a periodic review and revision of policies/processes for review of study activation and provide training and education for staff as needed and in coordination with other departments/managers
• Clinical trial website maintenance
• Communicate Clinical Trial monthly enrollments with outside institutions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Key Competencies

• Exceptional communication skills, both oral and written
• Strong knowledge and understanding of study activation processes
• Strong organizational and time management skills, attention to detail, efficiency, and a strong team orientation are essential
• Solid understanding of FDA regulations and Good Clinical Practice (GCP) guidelines governing the conduct of research in human subjects
• Must be proficient with the following software: Word, Excel, and Power Point; Zoom, Microsoft Teams, etc.
• Experience with databases preferred

Qualifications

• Bachelor’s Degree in healthcare or science field required.
• Clinical research study management experience or an equivalent combination of education and applicable clinical research experience – healthcare project management experience beneficial.
• SOCRA certified a plus.
• Minimal Travel required.

Position Requirements

• Able to see clearly in an environment which is equipped with typical lighting.
• Able to perform manual tasks that require the use of fine muscle motor skills.
• Able to walk approximately one mile per workday.
• Able to lift 25 pounds.
• Able to stand and / or sit for prolonged periods.
• Able to freely bend/stretch.
• Able to access, input and retrieve information from computers.
• Very fast-paced and ever-changing office environment.
• Demanding regarding deadlines and time frames.
• Very detailed and challenging work.
• Constant demand for updating knowledge.

Providing advanced treatments and compassionate care close to home.