Clinical Research Training Specialist
Do you want to help in the fight against cancer while working with innovative technology?
Cancer Research And Biostatistics (CRAB®) is looking for a Clinical Research Training Specialist to join our team.
CRAB® is a non-profit organization founded in 1997 whose mission is to help conquer cancer. We offer a highly competitive benefit package that includes paid time off, remote work days, FSA, retirement contributions, and more.
If you are looking to work for a great company and a great cause, we encourage you to apply!
Visit us at www.crab.org where you will find the required qualifications for this job.
Under supervision of the Program Director for Therapeutic Studies, the Clinical Research Training Specialist will provide subject matter expertise and collaborate with biostatisticians, data coordinators, and external stakeholders such as physician scientists acting as clinical trial study chairs and advance medical practitioners in the SWOG Oncology Research Professional (ORP) leadership. This position will lead efforts to develop, update and implement training materials and train employees and site staff across the United States using a variety of media. The Clinical Research Training Specialist works independently to ensure consistency and efficacy of informational materials, improve data quality and communication and strengthen our relationships with SWOG Oncology Research Professionals.
Primary Duties and Responsibilities:
- Leads development, implementation and review of subsequent effectiveness of training materials pertaining to internal staff and external site staff training for the SWOG Statistics and Data Management Center (SDMC)
- Manages and coordinates educational lifecycle of SDMC training materials
- Collaborates with members of the ORP committee, SDMC and SWOG Operations Office staff to maintain, revise and update the ORP Manual Coordinates in-person mentoring visits to institutions by SDMC staff to present in-depth SWOG clinical trial administration information, data collection and submission requirements with assistance and input by the SDMC mentoring team
- Collects input and writes articles for the SWOG CRA Newsletter
- Conducts and coordinates webinars for study-specific training, new initiatives, changes in data collection requirements, form design and Medidata Rave updates
- Creates online training videos for sites (addressing data management topics such as data entry, resolving queries, navigating the expectation report, etc.)
- Coordinates kick-off/study-specific training and content for bi-annual SWOG Group Meetings
- Liaises with the SWOG Clinical Trial Recruitment and Retention Specialist at CRAB and the Training Manager at the SWOG Operations Office
- Reviews and updates SWOG Study Chair training materials
- Leads and coordinates internal staff training sessions
- Reviews and updates the SWOG Data Operations Procedure Manual
- Performs other duties as assigned
- BA/BS in health, life sciences or similar field or four years of experience in clinical trials research setting may substitute
- PLUS an additional five years of experience in clinical trials research setting, including study design for complex multi-site studies
- Graduation from a research related certification program or certification in a recognized research related professional society (SoCRA, SCDM, ACRP) may substitute for three of the additional five years of clinical trials research experience
- Minimum five years of clinical trials research training and/or presentation experience
- Comprehensive knowledge of and proficiency using electronic data capture systems and an ability to learn new software quickly
- Proven ability to use sound judgment and diplomacy while interacting with staff and participating study sites
- Ability to lead and teach cross-functional groups and site personnel
- Proficiency in Microsoft Word, PowerPoint and Outlook
- Excellent written and oral communication skills
- Strong interpersonal and collaboration skills
- Out of state travel is required
Desired Knowledge, Skills and Abilities:
- SWOG clinical trials research experience with knowledge of SWOG study design Solid understanding of SWOG policies, procedures and organization-wide operations
- Understanding of anatomy/physiology, medical terminology, ICH/GCP Guidelines and AJCC TNM staging
- Experience with government funded clinical trials
- Familiarity with validation requirements to register a study with the FDA
- Demonstrated organizational skills with attention to detail
- Spanish language skills desirable
This is a full-time position and is Exempt from state and federal overtime regulations.
Employment authorization is required.
Travel/relocation expenses will not be provided for this position.
CRAB is an Equal Opportunity Employer.
In your cover letter, describe how your skills and experience match the qualifications for the position.
To apply visit us online at www.crab.org