This listing was posted on PrismHR Hiring.
Assistant Director, Team 1
Location:
San Antonio, TX
Description:
Flourish Research is where clinical trials thrive.Flourish Research represents one of the industrys most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!We are hiring an Assistant Director, Early Phase Services at our Clinical Trials of Texas site in San Antonio, TXI. PURPOSE: To assist in the provision of oversight, development, leadership, direction and management of the conduct/execution of multiple projects and programs for research related activities and personnel within the early phase department at Flourish Research. To carry out these responsibilities while ensuring subject/patient safety and while following applicable Flourish Research standard operating procedures (SOPs), policies and procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH) guidelines, Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. To promote, support and supervise the teams completion of the above while complying with Flourish Researchs mission statement and employee manual.III. ESSENTIAL JOB FUNCTIONS:A. Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with Flourish Research staff, sponsors/CROs, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physicians offices.B. Ensure the maintenance of confidentiality by team members of subject/patient information as appropriate and as bound by Confidentiality Agreements with Flourish Research, between Flourish Research and sponsors/CROs and between Flourish Research and other entities while abiding by HIPAA regulations.C. Able to perform all duties as specified in the Flourish Research Early Phase Operations Supervisor job description.D. Drive project execution to meet project schedule, and quality requirements.E. Potentially assist on multiple and complex protocols as CRC.F. Manage, train, coordinate and ensure PRN staff are fully trained and available to meet department needs for studies.G. Create overnight subject scheduling and planning.H. Review budgets for meals and supplies needed for each study.I. Manage procurement of medical supplies and equipment for teams studies.J. Manage pharmacy resources for teams studies.K. Follow and ensure compliance with Flourish Research SOPs by Team 1 team members.L. Assist in management of all team members involved in the conduct of Flourish Research studies to foster growth and success of Flourish Research and Flourish Research employees.M. Train, mentor and supervise early phase team members.N. Provide a leadership role in developing, implementing and evaluating Team 1 staff and the conduct of studies at Flourish Research.O. Visit tracking review in Real Time; ensure visits are being conducted per protocol timelines.P. Work closely with the regulatory department to ensure accuracy of informed consent documents, subject/patient stipend, training records and other documents necessary as part of the conduct of clinical research studies at Flourish Research.Q. Establish and maintain avenues for dissemination of vital communication to the Director, Clinical Operations; Senior VP of Clinical Operations; President/CEO; fellow team leads and department managers.R. Work closely with the regulatory department to ensure accuracy of informed consent documents, subject/patient stipend, training records and other documents necessary as part of the conduct of clinical research studies at Flourish Research.S. Attend manager meetings and trainings as well as other planning/organizational meetings as required by the Director, Clinical Operations; Senior VP of Clinical Operations; President/CEO; other team leads and department managers.T. Attending meetings to include but not limited to SIVs, periodic team meetings, budget meetings, trainings, etc. U. Attend recruitment meetings and develop strategies to meet enrollment goals.V. Provide pertinent communications (written and oral) of sufficient frequency to effectively disseminate information and/or to gain feedback regarding the teams performance and any issues requiring intervention/management.W. Ensure data integrity for all work performed by team members through close oversight and review of source document creation and review of data collection and entry procedures, and by performing periodic quality control reviews of completed work.X. Cultivating relationships with Sponsor/CROY. Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time.Z. Management of the startup and close out of studies assigned to team.AA. Perform periodic quality control reviews of completed work.BB. Monitoring visit reports/follow-up letters, and by interfacing with sponsor/CRO representatives.CC. Completes marketing and recruitment material reviews, including PRG reviewDD. LMAEE. Performance reviews of CRCs and CRCAsFF. Source document creation and reviewGG. Ensure sufficient and timely study start-upHH. Assist with interviewing, hiring and training team members for early phase;II. Other duties as assigned.IV. PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:A. Work is normally performed in a typical interior/office work environment.B. Travel 10%C. Exposure to human bodily fluids.D. Laboratory procedures to obtain specimens and processing of specimens.E. Subject/patient care.F. Daily computer use.G. Availability during weekends, holiday, and outside of core business hours may be required based on the demands of the projects being executed.H. Ability to properly lift up to 35 pounds and occasionally more than 35 pounds.Ability to drive and daily availability of an automobile.V. MINIMUM REQUIREMENTS:Education: Bachelors degree or higher.Experience:A. Minimum of one year experience conducting or managing clinical pharmaceutical/device research studies within the field of clinical research requiredB. Minimum of three years previous management experience is required;C. Previous early phase management experience required.Knowledge and Skills:A. Demonstrates core values & most skills needed in department;B. Able to demonstrate current knowledge of federal regulations/ICH guidelines and GCPs, IRB requirements, HIPAA laws, Flourish Research SOPs, Flourish Research employee manual and some knowledge of human resource laws;C. Possess strong clinical skills, i.e. accurate performance of ECGs, vital signs, subject/patient medical history, completion of visit specific source documents, obtain and process laboratory specimens, etc.;D. Proven ability to handle a large volume of paperwork efficiently and accurately;E. Ability to organize people and manage resources to complete projects in a timely manner and with accuracy;F. Demonstrate moderate to high level of computer skills including Microsoft Office, data entry systems utilized by sponsors, and RealTime software;G. Assists with training company new hires.Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status
Company:
Flourish Research
Posted:
March 29 on PrismHR Hiring
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More About this Listing: Assistant Director, Team 1
Assistant Director, Team 1 is a Executive Assistant Director Job at Flourish Research located in San Antonio TX. Find other listings like Assistant Director, Team 1 by searching Oodle for Executive Assistant Director Jobs.
Assistant Director, Team 1 is a Executive Assistant Director Job at Flourish Research located in San Antonio TX. Find other listings like Assistant Director, Team 1 by searching Oodle for Executive Assistant Director Jobs.