Working very independently and under very general supervision from a manager or Principal Investigator(s), provides support to clinical trials research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials, consenting patients, administering surveys to patients as part of clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, chart review, coordination and completion of paperwork related to clinical trials etc
Coordinates the implementation, both internally and externally, of sponsored clinical research trials/projects.
Initiates and maintains contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation. May be required to perform clinical tests such as phlebotomy, EKGs, etc.
Working in concert with Principal Investigator(s) and other members of the Clinical Research team, develops and implements patient recruitment strategies.
Subject visit preparation: Scheduling visits with subjects/booking CCI/coordinating physician attendance, prepare source docs, place orders in Epic and prepare supplies (blood tubes etc.)
Attendance at subject visits, ensuring compliance to study protocol
Process subject stipends
Interactions with CRAs and the pharmacy
Site initiation visit attendance
Lead coordinator for specific studies as well as OnCore management/Forte payments
ISF/Regulatory binder preparation
Trained in phlebotomy, EKG, vital signs etc.
All other duties as assigned.
BA or BS in biology, biochemistry or related field.
At least one year work experience in a clinical research setting.
Ability to work independently.
Excellent interpersonal skills are required for working with the study participants.
Good oral and written communication skills.
Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
High degree of computer literacy.
Excellent organizational skills and ability to prioritize a variety of tasks.
Careful attention to detail.
Ability to demonstrate professionalism and respect for subjects rights and individual needs.
Brigham And Women's Hospital