Job Title: Assistant Director, Early Phase Services
Department: Management/Clinical FLSA Classification: Exempt
I. 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 Clinical Trials of Texas, LLC. To carry out these responsibilities while ensuring subject/patient safety and while following applicable CTT 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 team’s completion of the above while complying with CTT’s mission statement and employee manual.
II. JOB RELATIONSHIPS:
Reports to: Director, Early Phase Services
Director of Clinical Operations
Direct Report/Workers Supervised: Early Phase Operations Supervisor; Clinical Research Coordinators (CRCs); Clinical Research Coordinator Assistants (CRCAs); PRN Research Technicians
Interrelationships: Works closely with other CTT team leads, department managers, regulatory, laboratory and business operations personnel, sponsor/contract research organizations (CROs) and outside vendors. Works closely with physician investigators and their staff to ensure subject safety, effective communication and successful conduct of CTT studies.
III. ESSENTIAL JOB FUNCTIONS:
A. Represent CTT in a professional and courteous manner (verbal, written and in appearance) when interacting with CTT 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 CTT, between CTT and sponsors/CROs and between CTT and other entities while abiding by HIPAA regulations;
C. Able to perform all duties as specified in the CTT 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 team’s studies;
J. Manage pharmacy resources for team’s studies;
K. Follow and ensure compliance with CTT SOPs by Team 1 team members;
L. Assist in management of all team members involved in the conduct of Team 1 studies to foster growth and success of CTT and CTT employees;
M. Train, mentor and supervise Team 1 members;
N. Provide a leadership role in developing, implementing and evaluating Team 1 staff and the conduct of studies at CTT; Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time;
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 CTT;
Q. Establish and maintain avenues for dissemination of vital communication to the Director, Early Phase Services, Director of Clinical Operations; Executive VP; other Clinical Team Managers and department managers;
R. Attend manager meetings and trainings as well as other planning/organizational meetings as required by the Director, Early Phase Operations; Director of Clinical Operations; Executive VP; other Clinical Team Managers and department managers;
S. Attend meetings to include but not limited to SIVs, Mock Runs, periodic team meetings, budget meetings, trainings, etc.
T. Attend recruitment meetings and develop strategies to meet enrollment goals;
U. Provide pertinent communications (written and oral) of sufficient frequency to effectively disseminate information and/or to gain feedback regarding the team’s performance and any issues requiring intervention/management;
V. 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;
W. Cultivating relationships with Sponsor/CRO
X. Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time;
Y. Management of the startup and close out of studies assigned to Team 1;
Z. Perform periodic quality control reviews of completed work;
AA. Review monitoring visit reports/follow-up letters, by interfacing with sponsor/CRO representatives;
BB. Completes marketing and recruitment material reviews, including PRG review
DD. Assist with staff evaluations and counselings;
EE. Source document creation and review
FF. Ensure sufficient and timely study start-up
GG. Assist with interviewing, hiring and training team members for Team 1;
HH. 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 required locally as well as within the continental United States. Travel from time to time may include locations outside of the North American continent;
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;
I. Ability to drive and daily availability of an automobile.
V. MINIMUM REQUIREMENTS:
Education: Bachelor’s degree or higher.
A. Minimum of one year experience conducting or managing clinical pharmaceutical/device research studies within the field of clinical research preferred but not required;
B. Minimum of three years previous management experience is required;
C. Previous early phase management experience preferred but not 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, CTT SOPs, CTT 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.