The Assistant Clinical Research Assistant is responsible for supporting all clinical research team members and assist with new and ongoing clinical research activities. The Clinical Research Assistant will perform a variety of routine clerical duties and assist with administrative tasks as assigned.
The Clinical Research Assistant will adhere to GCP, ICH, and FDA guidelines in the conduct of all study related activities.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Perform clerical duties including: answering phones, filing, copying, faxing, scanning, emailing, data entry, maintaining study logs, creating documents, scheduling meetings, archive study documents
Maintain and order study and office supplies
Provide assistance in study coordination for clinical trials as directed by the Director of Clinical Trials and/or Clinical Research Coordinator.
Provide assistance and support for all areas of clinical research
Assist with regulatory documents for IRB submissions, annual reviews and study close-out; maintain flow sheets
Participate in the process of ensuring that all Serious Adverse Events (SAEs) reported to Sponsor and IRB are resolved or maintained
Assist with the creation and update Regulatory Binders for each assigned study and patient/participant
Assist with monitoring visits
Interact/liaise with study sponsors and investigators in role of study representative
Assist in the verification eligibility screening interviews over the phone and/or in person
Assist with scheduling study patient appointments and make reminder calls to patients; send reminder letters and emails as appropriate; document contact.
Assist with conducting study patient visits per protocol, data collection and entry, specimen collection, and other study activities
Assisting with updating study patient visit tracking system and maintain related records
Assist in the completing, filing and updating paper and electronic study patient records
Assist in other recruitment/retention activities as needed, including calling potential participants and occasional outreach
Attend and complete trainings, staff meetings, and in-services as required
Assist lab personnel with specimen processing, shipping and ordering of supplies as needed
May be asked to attend Investigator Meetings for new trials
May be asked to travel to various HBHC locations
High School Diploma or equivalent
2 years previous experience ln research experience
Technical Medical Training Certification or completion of 2 years of college training
Strong organizational and communication skills with ability to multi-task while prioritizing responsibilities simultaneously.
Ability to execute verbal and written communication effectively
Take instruction/directives from physicians, nurses, pharmaceutical companies, third party vendors and all team members.