Senior Research Coordinator

Summary

Unique opportunity to provide centralized coordinator support within Office of Clinical Research (OCR) to multiple PIs on both therapeutic drug and device clinical research trials and across a variety of disease areas, including but not limited to cardiology, neurology, hepatology, infectious disease, nephrology, orthopedics, etc. This position is essential for coordination of OCR research portfolio at BCM and Baylor St. Luke’s Medical Center (BSLMC), liaising with principal investigators (PIs), regulatory staff, sponsor representatives, investigational pharmacy, and clinical team members to ensure that research studies are performed per federal regulations, sponsors' guidelines, and departmental policies. Provides cross-coverage across OCR team.

The Senior Clinical Research Coordinator role provides coordinator support to fast-paced and detailed therapeutic drug and device clinical research trials at BSLMC and BCM, across a variety of disease areas. This position is essential for coordination of Office of Clinical Research (OCR) research portfolio, liaising with principal investigators (PI), guiding less experienced research coordinators, and provides cross-coverage across OCR team.

This position requires ability to coordinate multiple research studies with multiple PIs. Ability to coordinate study activities that can be scattered across campus, and not always in the same location. Must be a team player and open to cross-training to support other team members on short notice. Ability to think outside of the box and be proactive. Good outward facing ability to interface with multiple departments across the College.

Job Duties

Interacts with study team and liaising with sponsors, PIs clinical team.

• Under direction of PI, drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.
• Trains clinical research personnel regarding enrollment/recruitment protocols and processes, identifying and clinical research subjects; monitoring enrollment goals and modifying recruitment strategies, as necessary.
• Precepts new clinical research staff and educating staff regarding scientific aspects of studies. Serving as a resource for the clinical research staff.
• Collaborates with research team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
• Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
• Serves as disease area team lead, assisting with study startup processes and feasibility for verification of staffing resources, patient population, clinical resources, etc.

Duties related to study activity:

• Participates in the PI meetings and in-service nurses and physicians.
• Leads, organizes and participates in pre-site and site initiation visits.
• Completes initial patient assessments, per competence, utilizing interview, observation and examination; obtaining vital signs and performs phlebotomy; performs phlebotomy per training and competence.
• Assists in budget development and CMS coverage analysis and study billing management.
• Independently manages time and prioritizes tasks.
• Provides ongoing communications with study subjects.
• Prepares IRB documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
• May coordinate travel requests and reimbursements.

Other Duties:

• Oversees and maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug/device accountability; monitoring documentation for quality and accuracy.
• Leads and conducts reviews on on-going studies and oversees quality assurance on ongoing protocols; promotes productive working relationship with study monitor.
• Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article/clinical supplies; maintains regulatory standards.
• Participates in monitoring report review activities for overall disease area specific trends and proactive issue resolution.
• Assists PI and team in planning and designing source documentation. Develops study specific forms or tools per protocol to use in clinical research and teaching research team how to use the assessment tool.
• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of institution and affiliates.
• Develops and conducting procedures for laboratory collection and storage.
• Participates in additional projects, and provides cross-coverage across OCR research portfolio as directed by research manager.
• Supports COVID clinical trial support as central office.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Clinical trial drug and/ device experience
• Therapeutic clinical research study experience
• ACRP Certified Clinical Research Coordinator or SOCRA Certified Clinical Research Professional certification

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

6141

CA; CH