Employment Type:

Shift:

Description:

GENERAL SUMMARY:
Assists in coordinating day-to-day activities associated with clinical research studies independently and under the direction of senior research staff and principal investigators to ensure that the objectives of an established research protocol are met and in compliance with IRB and sponsor guidelines. Identifies and recruits patients into study protocols as needed.

Essential Duties and Responsibilities:

• Interfaces with research subjects to recruit, assess eligibility criteria, determines subject availability, assists investigators with obtaining informed consent and assists with scheduling subject appointments.
• Conduct research interviews using a structured instrument.
• Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents .
• Enter, clean and manage research data.
• Communicates findings to the appropriate parties including research administration and managers, principal investigators, and members of the clinical research and regulatory compliance staff .
• Maintains the confidentiality of information acquired pertaining to patient, physicians,employees, and visitors to Saint Joseph Mercy Health System. Discusses patient and hospital information only among appropriate personnel in appropriately private places.
• Performs literature search for related research developments
• Special projects and other duties as assigned
• Assist in the preparation of IRB applications and submissions.
• Performs clerical duties, schedules meetings and maintains control of study related equipment and supplies.
• May assist with non-invasive study procedures with prior IRB approval (minimal risk studies only) upon completion of orientation requirements under direct supervision of a Research Coordinator or RN.
• Performs related responsibilities as required.
• Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participates in their resolution.
• Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.
• Behaves in accordance with the Mission, Vision and Values of Saint Joseph Mercy Health System.
  

Required Education, Experience and Licensure

• Bachelor’s degree in a related science, healthcare or business field or the equivalent combination of education and experience.
  

Required Knowledge, Skills and Abilities

• Excellent writing and interpersonal communication skills
• Ability to work both independently and in team-oriented settings
• Working knowledge of database systems and good basic computer skills
• Good organizational skills; efficient in the use of time and resources.
• Ability to work flexible hours to accommodate study and patient schedules.
  

Preferred Qualifications:

• At least one year of related work experience.
• Knowledge of research design principles, statistics, regulatory requirements and ethical requirements

Working Conditions

• Normal office environment and hospital patient care environment

Reporting Relationships

• Reports to senior research staff member

Our Commitment to Diversity and Inclusion

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.