Clinical Research Site Manager

Tekton Research Inc•San Antonio, TX

1d•Onsite

About The Position

Tekton Research is a growth-oriented clinical research organization committed to conducting high-quality clinical trials that advance medical knowledge and improve patient care. We are a collaborative, values-driven team that believes in Focus, Discipline, and Accountability. At Tekton Research, we take pride in doing excellent work while fulfilling our mission of Making Life Better. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment.

Requirements

5+ years’ experience in the Clinical Research Industry
Supervisory/management experience or demonstrated definitive leadership skills
Must be able to communicate in verbal and written form effectively
Must be able to read or learn to read scientific language and generalize information
Must be willing and able to adhere to instructions and regulations
Must demonstrate leadership skills

Nice To Haves

Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferred
College or Specialized Degree preferred

Responsibilities

Effectively managing day-to-day site activities for optimization of site performance.
Driving the site to achieve company goals.
Ensuring contractual obligations are met and work is completed in a manner that leads to client satisfaction.
Working with Tekton Leaders to problem solve issues that may interfere with achieving company goals.
Representing himself/herself and the site in the most professional, ethical and positive manner.
Reviewing and discussing awarded studies with the Principal Investigator to assist Tekton Leaders in making informed decisions about what studies to conduct.
Working with Tekton Leaders to make informed decisions regarding new staff needs for successful study conduct.
Working with Tekton Leaders to ensure site has proper space, staff, and time to optimize study conduct, particularly participant recruitment and retention.
Demonstrating knowledge of research, Tekton expectations, and industry standards.
Working closely with Tekton Leaders regarding staff management.
Leading staff in continued growth and excellent performance.
Hiring quality candidates for positions within the site.
Ensuring site staff is qualified and trained for roles and duties.
Working with Tekton Leaders to plan for upcoming studies.
Ensuring site staff and investigators are apprised of awarded studies.
Monitoring staff performance, holding staff accountable to expectations of role.
Ensuring staff complies with study protocols, FDA regulations, and ICH guidelines.
Ensuring staff complies with SOPs and other Tekton policies and processes.
Monitoring site quality and performance and developing solutions to optimize performance.
Monitoring study needs and assisting staff with study conduct and management, as needed.
Managing staff schedules for optimization of site performance.
Providing performance feedback to staff.
Working with Tekton Leaders to manage discipline, as necessary, HR issues, such as misconduct, violations of company policy, office turmoil, etc of coordinating staff.
Ensuring staff compliance with company Employee Handbook.
Developing strong working relationships with Investigators.
Ensuring Investigator coverage for optimal site visits.
Collaborating with investigator to ensure study success.
Managing site quality control process.
Monitoring adherence to SOPs and taking immediate corrective actions as necessary to ensure compliance.
Monitoring site staff to ensure highest quality performance and adherence to Good Clinical Practice and FDA Regulations and guidance’s. Taking immediate corrective actions as necessary to ensure compliance.
Serving as team member of Tekton.
Communicating effectively and professionally with other team members in a timely manner.
Representing Tekton in a professional manner.
Promoting harmony and professionalism within the workplace.
Acquiring and maintaining Tekton training: Tekton Research, Inc. SOPs, processes, and policies – every year or as changes are made.
Acquiring and maintaining Good Clinical Practice (GCP) – every 2 years.
Acquiring and maintaining IATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directed.
Participating in study-specific training as required.
Maintaining medical license(s), certifications, etc.
Ensuring site is prepared for study conduct.
Ensuring appropriate staff attends Investigator meeting and Site Initiation Visit.
Ensuring staff who will be participating on the trial are trained appropriately.
Ensuring source creation is completed and reviewed in a timely manner.
Working with Regulatory Staff to manage essential documents.
Completing site level Regulatory duties, including continuing reviews and study close outs.
Disseminating information to other personnel, as well as to potential patients.
Ensuring all staff is trained according to tasks that will be delegated.
Ensuring site has obtained all required documents and equipment to conduct study.
Ensuring site has received sponsor and IRB approval.
Communicating with the sponsor in a timely manner.
Communicating with others involved with/in the study, such as vendors, recruiting department and other resources as needed.
Ensuring recruitment goals for all studies are met or exceed.
Ensuring all study-related activities are completed per protocol. FDA regulations, ICH guidelines, and Tekton expectations.
Ensuring information is entered into case report forms completely and accurately.
Developing relationships and communicating with sponsors and sponsor monitors.
Ensuring data queries are completed efficiently.
Ensuring study documents are complete, current and filed correctly.
Ensuring laboratory procedures are completed accurately.
Managing study supplies.
Ensuring study closeout activities are completed efficiently.
Performing other duties as assigned.