POSITION OBJECTIVE
Working under limited supervision, coordinate research work on a five-year NIH-funded study in older women with breast cancer, according to the IRB-approved protocol. The study is designed to evaluate the effect of exercise on chemotherapy tolerance, body composition and many other patient-reported outcomes. Duties will include screening, recruitment, and enrollment of study participants, conducting patient and other stakeholder interviews, data collection and data entry responsibilities. The research assistant will work primarily with human subjects.
ESSENTIAL FUNCTIONS
Coordinate and oversee all subject visits as outlined in the IRB approved protocol. This will entail scheduling all subject visits and exercise trainers with proper time window as set forth in the study protocol. Ensure subject safety in conjunction with study investigators and exercise trainers. Assist exercise trainers with other duties as needed. Obtain all proper signatures in a timely manner. Collect and accurately record study data in source documents and case report forms. Design and maintain organizational tools to conduct the study in compliance with protocol guidelines. May monitor budget. Oversee inventory. (25%)
Carry out complex research assignments on a non-routine basis related to screening and identifying eligible participants for the study, recruit and enroll participants, obtain informed consent, conduct patient and stakeholder interviews, conduct geriatric assessments and medical records abstraction from electronic medical records, coordinate blood specimen collection, data collection and entry, make follow-up contacts with research subjects to help retain them and prevent study attrition, and mail materials to patients. The research assistant will be required to maintain certification for protection of human subjects. (25%)
Organize, coordinate and transfer all data collected from study subjects to the external overall coordinating site. Generate reports. (10%)
Track and maintain enrollment logs. Communicate enrollment targets, goals and strategies to the study co-investigator. (10%)
Develop new protocols for recruitment, ascertainment and enrollment of participants utilizing a high degree of skill and training in research and communications strategies. Evaluate adequacy of techniques; study and test new procedures and analyze data. (10%)
Conduct regulatory duties to ensure all study IRB requirements are in compliance. This will include submission of study protocols to the IRB and maintain the study in complaince with annual IRB review. (10%)
Working closely with the study principal investigator and co-investigator, review grants, assist with grant and manuscript writing and submission. Maintain a database of grants for the principal investigator to target, search websites and databases to conduct a literature review and review draft versions of grants and publications. May co-author research publications. (6%)
NONESSENTIAL
Attend weekly and monthly meetings. Coordinate and assist with investigators’ meetings including generating meeting minutes. (2%)
May monitor the laboatory budget. (2%)
Train new staff and direct the work of students. May supervise students and technicians. (1%)
Perform other duties as assigned. (1%)
CONTACTS
Department: Daily contact with supervisor to discuss research and maintain workflow.
University: Regular contact with study PI and other investigators and collaborators
External: Regular contact with staff at the coordinating center, Dana-Farber Cancer Institute, Boston, MA, and University of Pittsburgh. and other study investigators as needed.
SUPERVISORY RESPONSIBILITY
This position has no direct supervision of staff employees. May supervise students.
QUALIFICATIONS
Experience: 3 to 5 years of related experience. Previous clinical research experience preferred.
Education/Licensing: At least Bachelor of Science degree required, preferably in exercise physiology, science, or health-related field. Human Subjects Certification required.
REQUIRED SKILLS
Knowledge of commonly used concepts, practices, and procedures within clinical research.
Relies on instructions and pre-established guidelines to perform the functions of the job.
Ability to learn database software like Redcap, Oncore and Microsoft Access
Ability to interact with supervisor, investigators, and patients face-to-face.
Must have the ability to work collaboratively in a small team.
Ability to work under limited supervision.
Ability to meet consistent attendance.
Must be highly organized with excellent social and interpersonal skills.
Must be able to pay high attention to details with negligible/minimum error rate in carrying out study procedures and data entry.
Ability to maintain confidentiality and sensitivity to all aspects of working with human subjects.
Must have excellent interviewing skills and administer data collection instruments.
Experience working with older adults and/or patients with cancer diagnosis, experience conducting clinical research and obtaining informed consent, and experience and skill interviewing patients is desirable.
Excellent command of English language
Must have strong computer skills. Good knowledge of MS Office suite, especially Excel and Word.
WORKING CONDITIONS
General clinical research environment. May have exposure to hazardous material.
