Summary

Assists Principal Investigators (PI) in the coordination and implementation of clinical research. Reviews new clinical research protocols with the research team and provides feedback on feasibility. Organizes and manages activities related to initial and continuing IRB review. Serves as study contact for research sponsors throughout each study. Ensures that all supporting departments are notified and trained to conduct the study. Reviews medical records with investigator, recruits potential research participants, collects research data and ensures that all research procedures are conducted per the protocol, Federal regulations and Good Clinical Practice guidelines. Models appropriate behavior as exemplified in MLH Mission, Vision and Values.

Education/Experience/Licensure

Knowledge/Skills/Abilities

• Knowledge of research processes, regulatory issues, reporting requirements, Federal regulations and Good Clinical Practice guidelines.
• Demonstrated interpersonal skills with ability to successfully interact with physicians, other medical providers and associates.
• Ability to communicate technical material to physicians, clinical associates, patients and their families both verbally and in writing.
• Demonstrated skills in conflict resolution and problem solving.
• Demonstrated clinical and management ability.
• Demonstrated ability to handle numerous simultaneous projects.
• Ability to plan and schedule tasks and projects to maintain control of work flow for self and the work group.
• High attention to detail demonstrated in clinical and contractual settings.

Key Job Responsibilities

• Coordinates study activities under the direction of the Principal Investigator to ensure proper study conduct and research participant safety.
• Coordinates multiple projects under the supervision of multiple principal investigators.
• Ensures regulatory submission, complete source documentation and accurate data collection.
• Screens potential research participants with study investigators to ensure eligibility, and explains the research to them.
• Serves as point of contact for investigators, sponsors and patients.
• Works with the leadership of key departments to ensure awareness of study and compliance with the protocol.
• Obtains blood and tissue samples during study procedures. Ensures packaging and shipment according to appropriate guidance and regulations.
• Maintains proficient knowledge of study protocols, institutional and departmental guidelines, Federal regulations and Good Clinical Practice guidelines.

Physical Requirements

• The physical activities of this position may include climbing, pushing, standing, hearing, walking, reaching, grasping, kneeling, stooping, and repetitive motion.
• Must have good balance and coordination.
• The physical requirements of this position are: light work - exerting up to 25 lbs. of force occasionally and/or up to10 lbs. of force frequently.
• The Associate is required to have close visual acuity including color, depth perception, and field of vision to perform an activity, such as assessing patients (if Registered Nurse), preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading.
• Ability to react quickly to emergency situations.
• Exposure to patient body fluids as well as exposure to hazardous or poisonous materials.
• If Registered Nurse - Frequent invasive and non-invasive patient contact.
• If Registered Nurse - Ability to handle and administer narcotics and investigational drugs as needed.