CLINICAL TRIALS OF TEXAS, LLC Job Description
FLSA Classification: Non-Exempt
I. PURPOSE: To support research coordinators in the conduct of research studies. To assist under direct supervision of the Team Lead or Clinical Research Coordinator (CRC) in coordination activities and perform duties and procedures related to the start-up, conduct and close-out phases of clinical pharmaceutical research protocols. Under direct supervision and direction, to help obtain clean, objective and accurate data within sponsor timelines while following applicable federal regulations, medical ethics, Good Clinical Practices (GCPs), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. All responsibilities should be completed in accordance with CTT’s Mission Statement and Employee Manual.
II. JOB RELATIONSHIPS:
Reports to: Team Lead
Director, Clinical Operations
Senior V.P., Operations President/CEO
Workers Supervised: None
Interrelationships: Under direct and close supervision works closely with patients and sponsor representatives and to varying degrees frequently works with physicians and nursing staff at offices separate from CTT. May, from time to time, work with hospital staff members.
III. RESPONSIBILITIES:
- Represent CTT in a professional and courteous manner (verbal, written and in appearance) when interacting with CTT staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physician’s offices;
- Read and understand protocols and help to accomplish protocol specified patient visits and procedures as directed by assigned Team Lead or CRC;
- Under the direction of assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs;
- Obtain patient informed consent according to federal regulations, GCPs and IRB requirements;
- Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB and GCP guidelines;
- Assist in the scheduling and conduct of patient visits according to protocol requirements and timelines as directed by assigned Team Lead or CRC;
- Under close supervision maintain accurate and complete written source documentation of patient visits and protocol related activities;
- Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor;
- Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements with CTT, between CTT and sponsors, and between CTT and other entities;
- Promptly report adverse events to Team Lead, CRC or other supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary;
- Immediately report Serious Adverse Events (SAEs) to Team Lead, CRC, or other supervisor. May report SAE to the Principal Investigator/Sub-Investigator as deemed appropriate. Assist in the reporting of SAEs to sponsor within 24 hours of becoming aware of the SAE;
- Assist in the accountability of clinical trial materials (i.e. CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate amounts for the conduct of the study;
- Maintain ongoing communication with Team Lead, CRC’s, Director, Clinical Operations, Principal Investigator and other persons assisting with the trial and documents these communications according to protocol requirements and CTT policies;
- Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and CTT policies;
- Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research;
- May attend Investigator Meetings as directed;
- Perform all study-related duties in a time- and cost-effective manner in adherence with CTT policies;
- Perform all duties in a safe and prudent manner;
- Perform other duties as assigned.
- PHYSICAL REQUIRMENTS AND/OR ENVIRONMENTAL FACTORS:
- Work is normally performed in a typical interior/office work environment;
- Local travel required;
- Exposure to human bodily fluids;
- Laboratory processing procedures;
- Subject/Patient care;
- Extensive computer use;
- Occasional night and weekend work schedules;
- Ability to properly lift up to 35 pounds and occasionally more than 35 pounds;
- Ability to drive and daily availability of an automobile.
- MINIMUM REQUIREMENTS:
Education: Bachelor’s degree or adequate experience within the field of research to compensate. Experience:
A. Minimum of 1-3+ years’ experience within the field of clinical or biological research.
Knowledge and Skills:
- Demonstrates core values & all skills set required;
- Must have experience with Microsoft office applications (Outlook, Word and Excel) as well as internet- based applications;
- Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
- Must have good written and verbal skills;
- Must have good critical thinking and problem solving skills;
- Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics, and other employees;
- Must be professional, have a strong work ethic, be motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments;
- ECG, phlebotomy skills, and any other technical skills related to the completion of a study visit as required by the protocol;
- Must have the ability to adapt and take-on additional taks as requested;
- Assists with key initiatives/process improvements in the department;
- Assists with training company new hires;
- Completes at least 80% of goals annually.