TI Clinical Research Associate

Function/Duties of Position

This Clinical Research Associate position is responsible for implementation and overall management of neuro-oncology clinical trials. Under occasional supervision, coordinates complex, multi-center *therapeutic interventional (TI) clinical research protocols/programs and data management.

 

The TI Clinical Research Associate is a collaborative role supporting clinical research through a joint membership with the Department of Neurological Surgery’s Neuro-oncology Division and the Knight Clinical Research Management organization. The TI Clinical Research Associate will support the conduct of translational clinical research aimed at improving the lives of people and families with cancer by applying innovative strategies for cancer prevention, screening diagnosis and treatment. The support is provided through proactive, high quality and efficient study management in compliance with federal regulations and local policies and procedures. This fast-paced and highly intense research environment require management of complex clinical research studies involving a very vulnerable and sick population.

 

These responsibilities include:

• Assisting with components of the IRB submission, to include preparation of consent forms and other documents required for IRB review;
• Coordination of all aspects of a study as specifically outlined in the protocol. Primary focus will be subject safety and compliance with the prescribed protocol and Good Clinical Practice;
• Working collaboratively with physician, nursing, and ancillary staff in the scheduling and management of subject research activities.
• Maintaining accurate, complete and timely records on all research subjects including preparation of source documentation and clinical research data/case report forms;
• Ensuring that patient billing is accurate and assisting Manager and financial team in verifying appropriate clinical trial billing for very complex oncology trials. This requires the TI CRA to have a strong understanding of the study financial lifecycle and how their work directly impacts this.

May have direct patient contact, process biological samples and may perform other non-invasive testing such as ECGs. They will also assist in the continuing education of physicians, residents, interns, nurses and other related personnel with regards to knowledge of clinical trials and activities.

 

The TI CRA will represent the investigator and institution during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The successful TI CRA will have and maintain a working knowledge of National Cancer Institute (NCI), FDA, DHHS and other agency guidelines that govern clinical research. Additionally, the TI CRA is required to learn and remain up to date on the neuro-oncology disease sites their team manages. This includes understanding the basic disease processes and current standard of care therapies used for each disease site. The TI CRA must be able to apply this knowledge to the tasks they are assigned.

 

Contributes to feasibility assessment and research protocol management. Ensures research protocol implementation. Accurately applies investigators’ scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.

 

Given the complexities of oncology research and the challenges of working with a terminally ill population, strong customer service, organizational, and interpersonal skills are required.  Ability to clearly organize and/or adapt to multiple priorities and deadlines at one time is necessary.  Attention to detail, service orientation, delegation and project management skills, and above average critical judgment skills are essential.

 

* Therapeutic Interventional trials are treatment studies that involve people who have a disease or underlying condition. They include the administration and testing new treatments or new ways of using existing treatments, such as new drugs, vaccines, cell therapies, devices, experimental approaches to surgery or radiation therapy, etc.

Required Qualifications

Education & experience:

• Master's Degree in relevant field AND 3 years of clinical research coordination experience OR

• Bachelor's Degree in relevant field AND 5 years of clinical research coordination experience.

Knowledge, skills, and abilities:

• Ability to prioritize multiple tasks at one time.
• Excellent communication, analytical and organizational skills:  both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Intermediate skills with