ByAnn Inc. is looking for Physician with a private practice interested in additional revenue doing research as a Principal Investigator.
Responsibilities:
Assume responsibility for the conduct of the clinical trial.
Delegate tasks to qualified staff.
Ensure adherence to the study protocol in conducting clinical trial procedures.
Possess a thorough understanding of the requirements of each protocol.
Randomize/enroll study subjects that meet the eligibility criteria.
Ensure recruitment goals are reasonable and attainable.
Assess subjects’ response to therapy.
Review and assess trial subjects’ lab results in a timely manner.
Evaluate trial subjects’ adverse experiences. Assess Adverse Events (AE’s) and Serious Adverse Events (SAE’s) for severity and relationship to investigation product.
Report all serious adverse events immediately to the sponsor and IRB.
Acknowledge safety alerts and submit them to the IRB.
Communicate effectively with study subjects, research team, IRB, CRO and sponsor.
Meet regularly with the research team to discuss subject participation and protocol progress.
Ensure that all research staff are informed about the study progress.
Ensure research staff are trained on the protocol, and study specific procedures.
Prepare for and attend investigator meetings, site initiation visits, site monitoring visits, audits, etc.