Research Assistant

Job description

Clinical Research Assistant

1 year of Experience

Job Description

Medical Research Assistant

Medical Research Assistant will work in a team environment under the Leadership of the investigator with supervision of the Research Director or Team Lead.

Job Purpose: To promote good clinical practice in the conduct of clinical investigations. One must be able to assure compliance with protocol and regulatory requirements, by collecting, recording and maintaining data and source documentation.

Participates in Subject Recruitment, Enrollment and Follow up Procedures

By:

• Integrating proposed clinical trial with current research activities
• Attending and participating in investigator meetings
• Listing and clarifying questions and concerns with the sponsor and investigator regarding enrollment goals sponsor expectations and study procedures
• Monitoring enrollment goals and modifying recruitment plan as necessary
• Maintaining patient screening/enrollment logs
• Reviewing inclusion/exclusion criteria with investigator to assure subject eligibility
• Reviewing and verifying source documents in subject’s medical record to confirm subject’s eligibility assuring that all screening, eligibility and enrollment procedures are performed
• Reviewing the protocol, informed consent form and follow up procedure with potential study subjects
• Conducting interviews at assess the subject’s ability and willingness to follow and complete study procedures and visits
• Obtaining informed consent from research subjects prior to any study related procedures and documenting appropriately
• Following randomization procedures as per protocol
• Dispensing study article as appropriate
• Scheduling subject’s follow up visits
• Reviewing diaries and questionnaires completed by subjects
• Ensuring appropriate specimen collection, batching and shipping as required
• Assessing subject compliance with the test article and follow up visits

Protects Subjects Confidentiality

By:

• Protecting patient privacy during initial and follow up interviews
• Documenting protocol deviations and exemptions
• Obtaining/reviewing original source documents
• Abstracting data from medical records to clinic, consultation and referral notes to study forms and flow sheets
• Recording accurate and timely data onto case report forms
• Maintaining source documentation for all case report entries as applicable
• Keying data for electronic submission
• Transmitting data via fax, mail or electronically as requested
• Correcting and editing case report form entries as appropriate
• Resolving data queries
• Completing and maintaining the study article dispensing log
• Maintaining files of all study related documentation
• Recognizing and reporting common laboratory values and alerts to investigator and sponsor

Participates in Monitoring Visits and Audits

By:

• Scheduling sponsor monitoring visits
• Ensuring that EDC for Sponsor company is done within 3 business days and is correct
• Collecting source documents for sponsor/audit review
• Meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol related issues
• Preparing for and participating in FDA inspections as needed

Maintains Professional and Technical Knowledge

By:

• Attending educational workshops
• Reviewing professional publications

Job Type: Full-time

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off

Physical Setting:

• Clinic

Schedule:

• 8 hour shift

Work Location: In person