layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Associate Director, Clinical Research - Colorectal Medical Oncology at MD Anderson Cancer Center

Clinical Research Operations
Provide staff support to faculty members involved in developing clinical research trials and external collaborations.
Assist with protocol creation.
Assist with development of agreements.
Assist with collection of data.
Integrate cross-institutional information.
Oversee ongoing operations of clinical and translational research studies.
Oversee study start-up activities.
Oversee site initiation visits.
Oversee IRB submissions.
Oversee study amendments.
Regulatory Compliance & Protocol Oversight
Oversee audits and monitor findings.
Perform protocol process analyses.
Evaluate resources and obstacles to protocol activation.
Advocate for safe, efficient, effective, timely, and patient-centered care for research study patients.
Ensure compliance with institutional guidelines and regulatory requirements for sponsored research studies.
Partner with the Lead PI to evaluate protocol feasibility.
Oversee trial implementation across multiple institutional departments, centers, and Houston Area Locations.
Initiate standard operating procedures.
Design standard operating procedures.
Implement standard operating procedures.
Research Planning & Program Development
Serve as a liaison between investigators, institutional officials, sponsors, and partner sites.
Direct tracking of research activities.
Direct reporting of research activities.
Direct evaluation of research activities.
Act as an information resource for investigators and staff.
Prioritize studies with the greatest impact.
Identify low-accruing studies.
Resolve issues related to studies placed on hold.
Oversee implementation of new Beacon treatment plans through the clinical content template build process.
Oversee implementation of amended Beacon treatment plans through the clinical content template build process.
Strategic Leadership
Provide recommendations to the Department Chair regarding research policies and procedures.
Provide resource information for long-term strategic planning of research initiatives.
Identify funding sources for research initiatives.
Evaluate feasibility of strategic research initiatives.
Facilitate consistency in regulatory compliance across the department.
Support integration of departmental goals.
Provide administrative oversight for large programmatic contracts and agreements.
Participate in strategic planning committees.
Participate in program retreats.
Prepare and deliver formal presentations.
People Leadership & Quality Management
Lead development of methodologies to properly resource industry-sponsored clinical trials and laboratory studies.
Oversee research nursing teams.
Oversee clinical study coordinator teams.
Oversee GI translational teams and phlebotomy teams.
Oversee data coordinator teams.
Monitor workload distribution, attendance, performance, and productivity.
Conduct coaching, recruitment interviews, and annual performance evaluations.
Establish performance and productivity standards for staff.
Coordinate staff education, training, counseling, staffing, selection, and development activities.
Manage multi-site research activities, drug accountability, quality assurance, electronic patient data submissions, billing issue resolution, audit readiness, and research nurse coverage as needed.
EDUCATION
Required: Bachelor's Degree
Preferred: Master's Degree
WORK EXPERIENCE
Required: Seven years of experience in clinical research including protocol management, regulatory compliance and data management, to include three years of management experience or five years of experience in clinical research including protocol management, regulatory compliance and data management, to include three years of management experience with preferred degree.
Successful completion of the Leading Self Accelerate and/or Leading Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
LICENSES AND CERTIFICATIONS
Required: CCRA - Cert Clin Research Assoc or
Required: CHRC - Certified in Healthcare Research Compliance or
Required: CCRP - Certified Clinical Research Professional or
Required: CRA - Cert Research Administrator
OTHER REQUIREMENTS: Must pass pre-employment skills test as required and administered by Human Resources.
The University of Texas MD Anderson Cancer Center offers excellent

Associate Director, Clinical Research - Colorectal Medical Oncology

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