Senior Research Coordinator - Clinical Research (90008406)

Baylor College of Medicine

Houston, TX

Job posting number: #7080777 (Ref:7638-en_US)

Posted: July 2, 2021

Application Deadline: Open Until Filled

Job Description

Summary

This is a 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 interacts 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. 

Job Duties

•    Recruits, schedules and conducts the daily activities of clinical research participants, liaising with investigators and regulatory staff.  
•    Attends regular staff meetings, PI meetings and in-services with research nurses and physicians, regular study update meetings.
•    Leads, organizes and participates in pre-site and site initiation visits, and in-services for clinical areas involved in conduct of study. 
•    Completes initial patient assessments, per competence, utilizing interview, observation and examination; obtaining vital signs and performs phlebotomy; performs phlebotomy per training and competence.
•    Supports budget development and CMS coverage analysis and study billing management.
•    Assists with answering IRB stipulations to obtain final approval; May coordinate travel requests and reimbursements for research patients.
•    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.
•    Provides clinical trial support for emerging College priorities as a central office.
•    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.
•    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. 
•    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 conducts procedures for laboratory collection and storage.
•    Trains clinical research personnel regarding enrollment/recruitment protocols and processes, and identifying clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary.
•    Preceptor for new clinical research staff, educates staff regarding scientific aspects of studies; serves 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 think critically by verbally expressing rationale for decisions and following up consistently. 
•    Serves as a disease-area team lead, assisting with site qualification, study feasibility for verification of staffing resources, patient population, clinical resources, etc., and study startup processes.
•    Participates in additional projects as directed by research manager, as a central office within the Office of Research.
 

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.

 7638

CA; CH 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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More Info

Job posting number:#7080777 (Ref:7638-en_US)
Application Deadline:Open Until Filled
Employer Location:Baylor College of Medicine
Houston,Texas
United States
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