Clin/Tran Research Coordinator II - Ortho Joints

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Organization:

Orthopaedic Surgery & Rehab

Job Summary:

A full-time Clinical/Translational Research Coordinator II with previous clinical research experience is sought to work as part of an energetic and fast-paced team of clinical researchers in the Orthopaedic Surgery Total Joints division.

The coordinator will work closely with study PIs and other research staff to implement several new PI-initiated and industry-sponsored clinical research studies and other division research projects as needed. Primary responsibilities will include screening/consenting patients, administering questionnaires, conducting phone interviews, performing in-person assessments/research procedures, monitoring for adverse events, managing data/queries, scheduling research visits and orders, as well as assisting with IRB/regulatory requirements and research admin tasks such as subject reimbursement, sponsor invoicing, etc.

The position requires at least 2 years of previous human research experience, excellent organizational and communication skills, and an ability to work independently and solve problems as they arise. The ideal candidate will be detail-oriented, adaptable, and able to interact comfortably and confidently with patients, colleagues, MDs, and clinic/administrative personnel.

This position is eligible for a Hybrid work schedule: approximately 2 days per week working from home. Actual ratio may vary week to week based on immediate needs.

JOB SUMMARY
Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies, under occasional guidance.

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KEY RESPONSIBILITIES
• Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation. Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
• With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate