Responsible for management, administration, organization and conduct of all ACRC Trials research sites (Austin, Carrollton, Frisco, Grapevine, and Plano, TX).
Provides leadership, training, coaching and mentoring of managers and staff.
This position is office based in Plano, TX. This is not a remote position.
Provides staff with expert clinical research and therapeutic advice.
Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.
Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
Collaborates with other department and/or functional groups to ensure consistency of processes.
Supports management in assuring professionalism and adherence to company principles of Customer Service.
Champion/drive implementation of new company initiatives in terms of process improvement or new technology related to clinical research.
Directly or indirectly supervise study staff, technical and professional staff.
Demonstrate ability to lead by example and to encourage team members to seek solutions.
Assists Director with:
review and revision of departmental SOPs, working practices, and policies.
development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
Process Improvement Plans and other special projects as required by the department.
Develops strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
Initiates collaborative relationships with external institutions when protocol required.
Initiates procurement of external resources, consultants, or equipment when protocol required.
Oversee all required study startup training, documentation, start-up tasks and timelines on assigned study protocols.
Conducts field evaluation visits with staff at sites.
Collaborate with corporate teams to ensure staffing, start-up, and trial goals are met.
Maintain effective, courteous and ongoing communication with staff, sponsor, research participants, and PI during the course of trials.
Oversee training for all protocols as well as requirements for regulations.
Support the team and investigators in overall conduct of trials.
Assists with organizing and conducting Staff Meetings at regular intervals and addresses issues discovered at meetings.
Ensure monitoring visits and sponsor/FDA audits are completed successfully.
Quality Assurance – ensure the subject charts have been QA’d and are up-to-date and audit ready.
Ensure that all work is carried out in strict adherence with relevant protocols, SOP's, and in compliance with ICH/GCP guidelines. Ensure that managers/research staff is trained and compliant with SOP's and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
Ensure that the safety, welfare and dignity of subjects are not compromised.
Ensure that the office, scientific and medical standards provided are met.
Collaborates with Director to develop and administer an effective orientation/on-boarding process for new hires
Coach, train, and support research staff
Assesses and organizes appropriate training requirements for research staff
Communicates staff training needs to Director
Assists Director to create and deliver new department initiatives, improvement plans or training
Ensure that the staff is adequately trained to meet the quality standards and forecasted workload.
Monitors and records subsequent performance to assess the effects of training on efficiency.
Direct staff: hr documentation, recruitment, training, compliance, travel, scheduling and coverage, evaluations, discipline, and terminations.
Reviews and approve time sheets and expense reports as required.
Assists Director with interviewing and making hiring recommendations and/or decisions on new staff.
Communicates staff increase and equipment needs to Director.
Writes and delivers performance appraisals
Holds regular one-on-one meetings with staff to discuss performance
Experience and Skill Requirements:
Advanced degree preferred. Additional experience may be substituted for education requirements.
Bachelor's degree required; RN/NP/PA degree a PLUS.
At least 5 years of clinical research coordinator experience, including 1 year of management experience at a clinical research organization.
Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.
Ability to multi-task, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
Strong computer skills in relevant software and related clinical systems are required.
Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail.
About ACRC Trials
ACRC Trials is an investigator site network of award-winning physician practices and clinics, specializing in Phase II-IV pharmaceutical and device studies. Our location at Legacy Medical Village, a master planned facility that offers primary care and complements it with open-access to independent specialty practices and convenient services, allows us to offer a distinct level of service to the medical research community.
With an emphasis on excellence, reliability, and volunteer care, ACRC Trials is one of the leading research institutions in the US. ACRC Trials is committed to upholding the highest standards of quality in implementing clinical research studies and managing volunteer safety. We have an outstanding reputation of providing great data and meeting our commitments with efficiency and integrity. ACRC Trials has preferred partnerships with most Sponsors and CROs.