Clinical Trials Research Coordinator

SUMMARY

Under the general supervision of the Principal Investigator(s) and Clinical Research Coordinator assist in acquisition and analysis of patient information for multiple clinical research projects. Interviews patients to gather information prepares and maintains study record enters data via computer performs statistical analyses of resultant data. Participates in qualitative/quantitative analyses of resultant data. Reviews relevant literature to gather information; may participate in development of research protocols.

Help in submission of IRB protocols and document gathering. If licensed, may help with blood draws, patient vitals, and other medical responsibilities. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done.

The core Success Factors include:
Instill Trust and Value Differences;
Patient and Community Focus and Collaborate.

• Provides assistance to Principal Investigators to coordinate clinical research activities related to departments field of study and investigators specific study.
• Assists research physician in identification and follow up of patients meeting criteria for inclusion in clinical research studies; ensures protocol eligibility requirements are met.
• Establishes and/or maintains study record for each participant. Interviews patient and/or family to explain nature of study elicit cooperation and gather information to complete study questionnaire. Facilitates obtaining informed consent.
• May schedule patient appointments and call patients to complete documentation.
• May review medical records to abstract information necessary to complete forms.
• Request and follow up on missing data such as laboratory test results and the like.
• Monitors adherence to protocol; alerts physician when laboratory tests ordered have not been performed medication protocol not followed etc.
• Collects and organizes patient data into appropriate format to facilitate data entry.
• Computer entry of study information into database. Using pre-packaged software and according to needs of research supervisor performs computer-assisted statistical analysis such as multiple antecedent variables linear regression frequencies cross tabulations and the like.
• Attend meetings, conferences, seminars, and applicable training as required.
• Ensure that all staff adhere to policies and procedures of any clinical site where study is being performed and adhere to all institutional health, safety, and infections control regulations and requirements.
• Coordinates activities of others assigned to research project to interview patients compete forms or perform other tasks.
• Reviews literature pertaining to research being conducted in order to better understand project and gather relevant information.
• Identify additional needs for development of departmental methods or procedures and action accordingly.

• BA/BS in related field, scientific or nursing, 1-2 yrs. related experience, previous experience coordinating industry sponsored research trials and administration.
• Strong organizational and communication skills required.
• Must be comfortable working with older adult populations.
• Must have experience with electronic medical records/Epic, Phlebotomy and EKG skills, BLS Certification.
• Previous research study experience.
• Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary.
• Ability to prioritize tasks; knowledge of theory and techniques of research methodology.
• IRB experience (document submission, editing, CITI, etc.).
• Computer data entry: prepare and maintain records and reports etc.
• Interpersonal skills to effectively interact with patients’ families, MD’s and hospital professionals.
• Analytical skills to participate in developing research protocols, perform statistical analyses and participate…