Description
Responsibilities- Write clinical protocols, case report forms and other clinical trial documents.
- Prepare, submit, and manage renewal of IRB protocols and documentation
- Assist in the writing, editing, and online submission of abstracts, posters and manuscripts.
- Communicate professionally with academic and commercial collaborators; set up and lead site qualification, initiation and close-out meetings
- Monitor clinical study sites in-house (no travel required) and be the point of first contact for patient inclusion/exclusion inquiries from collaborators
- Perform queries on clinical data and CRFs to ensure that the study is compliant with the protocol and eligibility criteria
- Perform data management tasks such as transferring hardcopy CRF data into an electronic database system
- Participate in departmental planning sessions and SOP development.
- Handle organization and shipment of fresh and cryopreserved patient samples
- Manage the blinded clinical sample database; perform quality checks on data spreadsheets/data tables; prepare graphical representations of clinical data
- Write and distribute meeting minutes
- Perform literature searches and compile information on therapeutic agents, regulatory document, manuscripts etc.
- Gain certification in phlebotomy, draw blood on an ad hoc basis as needed
Requirements
- Candidate must be available to begin full-time employment immediately
- Bachelor of Science degree or equivalent, majoring in one of the following fields: Biology, Chemistry, Biochemistry, Health Sciences, Combined Science or Physics
- Flexible and motivated to learn clinical development and laboratory aspects of medical diagnostics
- Strong Microsoft Office Suite skills, ability to gain proficiency in specialized programs such as sample inventory programs, etc.
- Strong and meticulous data entry, organization, and management skills
- Effective time management and organizational skills
- Perform well in a cross functional team structure and small company environment
- Research experience including some formal data analysis
- Candidate must be able to legally work in the U.S. - no visa sponsorship available for this position
To find out more about Real please visit www.realstaffing.com