Research Study Coordinator

VA Boston Healthcare System is looking for a Study Coordinator to join our team.

The VA Research Program strives to promote Veteran-centered care to improve patient experiences and outcomes across VA healthcare and community settings, and to advance value-driven care by providing Veterans the highest quality care at the lowest financial burden.

The Study Coordinator may be assigned to one or more clinical research studies and functions under the overall direction of the Principal Investigator (Pl) and/or other research specific leadership. The position has a high level of knowledge of the instruments and techniques of clinical trials research and/or epidemiologic studies; knowledge of the methodologies of data analysis; and experience in the conduct of human subjects' research.

The major duties include but are not limited to:

Manages Clinical Tests and Collects Data

• Manage implementation, control and reporting on clinical tests.
• Implement data collection and monitor protocols for difficult clinical research studies. Administer or monitor administration of tests and measurements required by project design.
• Record data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study.
• Assist with data analysis from a variety of sources, including databases and spreadsheets,. and conceive and write reports as needed.
• Help respond to inquiries from a sponsor, clinical research coordinating center and/or site Pl on matters related to data, data compliance, and subject complaints related to data collection.
• Help ensure that data collection and transmission activities are compliant with applicable data security and privacy policies.

Recruits and Manages Candidates for Clinical Trials

• Oversee recruitment and enrollment of participants, providing information on study objectives and constraints.
• Obtain verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information (as needed) from patients ensuring that the process adheres to HIPAA, information security and other federal regulations regarding confidentiality and the conduct of human subjects' research.
• Coordinates study participant randomization to treatment, works closely with the Research Pharmacy on study drug provision.
• Identify study adverse events and side effects, symptoms which might require intervention or referrals in order to facilitate treatment of clinical research participants

Research Project Support

• Plan, develop, complete, and submit on time all required documentation/ paperwork/forms for initial and continuing human subject's review.
• Analyze processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations. Regularly review guidance, policies, and procedures to maintain regulatory compliance.
• Schedule meetings, including scheduling meeting space, notifying participants, preparing the agenda and minutes and following-up on all commitments to ensure that necessary arrangements have been made.
• Manage participant compensation, maintain compensation records, and prepare invoices
• Organize and maintain all study documents for management, data, record keeping and/or compliance purposes.

QUALIFICATIONS

All applicants must meet the Basic Education Requirement: Successful completion of a bachelor's degree (or higher) from an accredited college or university in a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position.

In addition to meeting the Basic Requirement, all applicants meet one of the following qualifications:

SPECIALIZED EXPERIENCE: At least one (1) full year of specialized experience that has given you the particular knowledge, skills and abilities required to successfully perform the duties of this position and that is typically in or related to the work of the position to be filled. Specialized experience is providing day-to-day administrative support in human subject research activities such as maintaining accurate records, collecting and analyzing data, tracking participants, troubleshooting study procedures, communicating with clinicians and study subjects, and applying comprehensive understanding of the regulatory requirements and ethical principles that guide human subject research.

~OR~

EDUCATION: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have successfully completed a masters or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree in a field which demonstrates the knowledge, skills, and abilities necessary to perform the work of the position.

~OR~

COMBINATION: Equivalent combinations of successfully completed graduate-level education (beyond the first year) and specialized experience, as described above, which meet the total experience requirements for this grade level. The education portion must have provided the knowledge, skills, and abilities necessary to do the work of this position (as described above).

Pay: $57,150.00 - $69,905.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Application Question(s):

• Do you have a bachelor's degree (or higher) from an accredited college or university in a major study in an academic field related to the medical field, health sciences or allied sciences?
• Are you comfortable working in an onsite setting?
• Are you a U.S. citizen or national?

Work Location: In person