Job Type: Regular
Time Type: Full time
Work Shift: Day (United States of America)
FLSA Status: Exempt

REQUIRED QUALIFICATIONS:

• Bachelor’s degree required.
• 3-5 years related work experience required in clinical research.
• Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.

PREFERRED QUALIFICATIONS:

• Prior grant management experience.
• Academic degree in a scientific discipline.
• Ability to converse and comprehend in a foreign language would be strongly preferred.

KNOWLEDGE:

Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.
Teamwork:
Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.

• Partners with Principal Investigator (PI) to hire, train and coach Clinical Research Staff.
• Provides feedback to PI regarding annual performance evaluations of staff.
• Ensures that schedules, follow-up and completion of research protocols progresses as planned.
• Works with staff to resolve day-to-day problems.
• Implements process of protocol for various clinical trials; coordinates sponsor conducted initiated visit(s); assists in the execution of new IRB applications and processes annual reviews for the IRB committee with regard to consents.
• Collaborates with PI and/or Research Nurse in submission of protocols, amendments, notices, suspensions and terminations to the IRB for review and approval.
• Attends IRB meetings as required and addresses any IRB questions regarding the protocols or consent forms.
• Assesses potential patients’ eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol.
• Checks all eligibility or ineligibility criteria with the patients’ medical record.
• Verifies information with Research Nurse and/or PI. Enrolls patients onto clinical trials or oversees enrollment process.
• Discusses and obtains informed consent with patients.
• Revises protocol consent form to comply with federal, state and IRB guidelines. Interacts with patients prior to entering the study and throughout the entire treatment.
• Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB.