Clinical Research Coordinator I/II

Job Summary

The Center for Suicide Research and Prevention at MGB/Harvard is seeking applications for 1 full-time Clinical Research Coordinator (CRC) to coordinate and administer an NIMH-funded project (led by PI Dr. Matthew Nock) aimed at building and leveraging new interventions to identify suicidal risk and prevent suicidal behaviors. The target population is adults presenting to the emergency department for suicide risk or other mental health related concerns. This position is particularly well-suited for anyone interested in pursuing graduate study in the fields of psychology, public health, or medicine.

Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; ensuring regulatory compliance; and maintaining and updating data generated by the study.

Essential Functions

• Reviews proposals for compliance with sponsor and organizational guidelines; verifies that all sponsor requirements are met.
• Recruiting patients for clinical trials and conducting phone interviews.
• Verifies the accuracy of study forms and updates them per protocol.
• Prepares data for analysis and data entry.
• Documents patient visits and procedures.
• Assists with regulatory binders and QA/QC Procedures.
• Assists with interviewing study subjects.
• Assists with study regulator submissions.

Principal Duties & Responsibilities

• Collects & organizes patient data
• Maintains records and databases
• Uses software programs to generate graphs and reports
• Recruits and enrolls patients for clinical trials
• Obtains patient study data from medical records, physicians, etc.
• Conducts library searches
• Verifies accuracy of study forms
• Updates study forms per protocol
• Documents patient visits and procedures
• Assists with regulatory binders and QA/QC procedures
• Assists with interviewing study subjects
• Administers and scores questionnaires
• Provides basic explanation of study and in some cases obtains informed consent from subjects
• Performs study procedures
• Assists with study regulatory submissions
• Assists with developing consent forms and study protocols
• Verifies subject inclusion/exclusion criteria
• Performs administrative support duties as required

A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:

• Maintain research data, patient fields, regulatory binders and study databases
• Perform data analysis and QA/QC data checks
• Organize and interpret data
• Develop and implement recruitment strategies
• Act as a study resource for patient and family
• Monitor and evaluation lab and procedure data
• Evaluate study questionnaires
• Contribute to protocol recommendations
• Assist with preparation of annual review
• May assist PI to prepare complete study reports

Knowledge, Skills & Abilities

• Careful attention to detail and good organizational skills.
• Ability to follow directions.
• Good interpersonal and communication skills.
• Computer literacy.
• Working knowledge of clinical research protocols.
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
• Ability to navigate, make decisions, and respond to a fast-changing environment.

The Clinical Research Coordinator II should also possess:

• Ability to work independently and as a team player
• Analytical skills and ability to resolve technical problems
• Ability to interpret acceptability of data results
• Working knowledge of data management program

Supervisory Responsibility

A Clinical Research Coordinator I does not have any supervisory responsibility. A Clinical Research Coordinator II may assist with the training and orientation of new staff members.