Clinical Research Manager

Clinical Research Manager

Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.

40% Plan and direct assigned clinical research trials and projects in the clinical setting:

• Advise principal investigator by planning and conducting the nursing protocol portion of the research protocol.
• Maintain compliance with Good Clinical Practice guidelines and Food and Drug Administration’s regulations on all research activities.
• Manage recruitment with the CTSI recruitment center and PI/HST teams with the recruitment of study subjects including identifying appropriate subjects, determining eligibility, obtaining informed consent, and enroll patients in study.
• Coordinate the collection of research data; create data collection tools through applications such asREDCap.
• Explain research protocol to participants; respond to patient inquiries regarding protocol; schedule patient participation; ensure compliance with research protocol

40% Direct education and nursing care in support of clinical research trials and projects in clinical settings:

• Provide clinical care to participants enrolled in clinical trials.
  Administer treatments and/or investigational medications in accordance with research protocols.
  Initiate ordering of necessary tests, equipment and medications per protocol.
• Perform specialized tasks such as pharmacokinetic sampling, euglycemic clamp procedures, administration of conscious sedation; assisting with invasive procedures such as liver biopsies and bronchoscopies.
• Collect body fluid specimens, including timed specimens for pharmacokinetic assessments.
• Processes specimens for storage and shipping as required by protocol.

15% Provide Administrative support to assigned research trials and projects:

• Provide administrative support to NIH’s WEBCamp scheduling and data tracking system.
• Maintain detailed records of clinical research trials and projects, including data collection, while maintaining HIPAA compliance standards regarding patient confidentiality.
• Alert Principal Investigator(s) to any Adverse Events/Serious Adverse Events for timely reporting to the IRB when appropriate.

$84,000-$92,000

Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.

• Four years of nursing experience in a clinical research setting.
• ACLS certification.
• Knowledgeable regarding IRB procedures, forms and approval process
• Knowledge of nursing principles, practices and techniques
• Knowledge of basic principles and good clinical practice of clinical research
• Experience coordinating clinical research studies
• Skill in the use of nursing equipment and instruments
• Ability to collect, collate, analyze and evaluate data from clinical research studies
• Ability to plan, organize and coordinate work assignments
• Ability to work effectively and independently
• Ability to communicate effectively, both verbally and in writing
• Expertise in phlebotomy

Please upload a cover letter and resume when submitting your application.

This position is time limited.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.