Job Title: Clinical Team Manager I

Department: Management/Clinical FLSA Classification: Exempt

I. PURPOSE: To supervise and manage a team of clinical research coordinator assistants (CRCAs) and/or clinical research coordinators (CRCs) to ensure successful execution of clinical pharmaceutical and device research protocols conducted at Clinical Trials of Texas, LLC (CTT). 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, Late Phase Services

Director, Clinical Operations

Executive VP

Direct Report/Workers Supervised: CRCs, CRCAs, Clinical Administrative Assistants

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 Senior CRC job description;

D. Coordinate multiple and complex protocols;

E. Follow and ensure compliance with CTT SOPs by team members for assigned team;

F. Manage all team members involved in the conduct of CTT studies to foster growth and success of CTT and CTT employees;

G. Provide a leadership role in developing, implementing and evaluating the conduct of studies at CTT;

H. Manage activities performed by assigned team to improve organizational performance;

I. Assist with screening/interviewing/hiring team members for assigned team;

J. Train, mentor and supervise CTT team members on assigned team;

K. Perform periodic written and verbal evaluations of team members per CTT policies and procedures;

L. Manage requests for time off by team members as well as their daily/weekly schedules to ensure adequate staffing at all times to meet the demands of assigned protocols and overall team workload;

M. Back-up team members during absences and/or heavy workloads to ensure that work is completed accurately and on time;

N. Schedule and attend meetings to include but not limited to pre-Site Initiation Visits, SIVs, periodic team meetings, trainings, etc. 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;

O. Oversee and supervise the startup, conduct and close out of studies assigned to the team;

P. Provide quality control review of subject/patient charts prior to randomization or screen fail to ensure accuracy of status determination;

Q. Provide close oversight and review of data collection, data entry as well as protection of data integrity for all studies assigned to the team;

R. Ensure data integrity for all work performed by assigned team members through close oversight and review of source document creation and utilization in the study, of data collection and entry procedures, and by performing quality control reviews of completed work;

S. Provide supervision and oversight of team members to the degree necessary by reviewing/monitoring study-specific logs, QC Yellow Sheets reflecting CTT internal queries, RealTime CTMS entries, monitoring visit reports/follow-up letters, and by interfacing with sponsor/CRO representatives;

T. Ensure that enrollment goals for all studies assigned to the team are met and assist with enrollment on other teams to ensure overall success of CTT;

U. Interface with budget and contract personnel to assist with initial budget creation and review and when amendments to the protocol or study budget are made;

V. 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;

W. Establish and maintain avenues for dissemination of vital communication to the Director, Clinical Operations; Executive VP and other team leads and department managers;

X. Ensure continuous high level involvement by principal investigators as required by FDA regulations/ICH guidelines and CTT SOPs by maintaining frequent communications with and training of physician investigators and their staff;

Y. Attend manager meetings and trainings as well as other planning/organizational meetings as required by the Director, Clinical Operations; Senior Executive VP and other team leads and department managers.

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. Occasional night and weekend work schedules may be required dependent upon team assignment;

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.

Certification: Certified Clinical Research Coordinator through an industry recognized professional organization.

Experience:

A. Minimum of 2+ years at CTT plus 1-3 years’ experience conducting or managing clinical pharmaceutical/device research studies within the field of clinical research;

Knowledge and Skills:

A. Consistently demonstrates core values & proficiency of skills set;

B. Previous management experience is preferred;

C. 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;

D. 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.;

E. Proven ability to handle a large volume of paperwork efficiently and accurately;

F. Ability to organize people and manage resources to complete projects in a timely manner and with accuracy;

G. Demonstrate moderate to high level of computer skills including Microsoft Office, data entry systems utilized by sponsors, and Real-Time software;

H. Assists with developing and implementing key initiatives in the department;

I. Assists with identifying and implementing process improvements;

J. Seeks out opportunities to help achieve department/company goals;

K. Fosters relationships across teams;

L. Consistently accomplishes 80% of individual quarterly goals and objectives;

M. Assists with training and mentoring department new hires;

N. Demonstrates good critical thinking and decision making resulting in sound judgement;

O. Industry certified as applicable.