1) Coordinate day-to-day management and administration of the study, including team communications, supervision and training of support personnel, financial management / study budgets, protocol development, project implementation and evaluation, milestone tracking, and coordination with subcontract project sites.
2) Manage all aspects of conducting clinical trials including: protocol development for screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
3) Recruit and interview potential study patients with guidance from PI and other clinical research staff.
4) Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
5) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
6) Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
7) Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
8) Performs assessments at visits and monitors for adverse events.
9) Organizes and attends site visits from sponsors and other relevant study meetings.
10) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
11) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
12) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
13) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
14) Ensures compliance with federal regulations and institutional policies.
15) May prepare and maintain protocol submissions and revisions.
1) Ability to communicate with tact and diplomacy.
2) Strong organizational skills.
3) Strong communication skills (verbal and written).
4) Ability to communicate with tact and diplomacy.
5) Ability to handle sensitive matters with tact and discretion.
6) Excellent interpersonal skills.
7) Strong data management skills and attention to detail.
8) Competency in statistical package required, RStudio.
9) Ability to participate in protocol review and clinical trials evaluations.
10) Knowledge of medical terminology / environment.
11) Ability to handle competing demands with diplomacy and enthusiasm.
12) Excellent time management and ability to prioritize work assignments.
13) Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
14) Familiarity with Good Clinical Practices (GCP).
15) Ability to read and understand clinical trials protocols.
1) Bachelor's degree
1) 2 years of clinical research experience or relevant experience
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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