SUMMARY: The Paramedic oversees study procedures, performs study procedures, and provides medical coverage as needed while subjects are in-house. He/she performs technical, laboratory, and administrative tasks following Worldwide Clinical Trials (WCT) procedures and study protocol requirements. The Paramedic works under the direct supervision and guidance of the Senior Manager, Medical Group. He/she will provide direction and indirect supervision for technical and laboratory staff in the absence of a Full-Time Supervisor. RESPONSIBILITIES:
Tasks may include but are not limited to:
- Always represents WCT in a professional manner (verbal written and in appearance) when interacting with sponsors, subjects, outside vendors and fellow employees.
- Under the direction of the Medical Director’s standing orders, functions as WCT medical coverage in case of an emergency for subjects visiting WCT.
- Oversees all study procedures to ensure that they are performed on time, following both the study protocol and WCTEPS procedures.
- Acts as the primary contact for subjects while in-house when the Coordinator is not available.
- Documents all adverse events reported and observed per WCT staff or protocol requirements while subjects are in-house.
- Contacts the Medical Director, Coordinator, and/or Principal Investigator as needed.
- Indirectly supervises technical and laboratory staff in the absence of a Full-Time Supervisor.
- Performs phlebotomy on subjects as needed at timed intervals.
- Once trained, performs the following procedures per WCT guidelines and study protocol requirements:
- Vital signs
- Serves meals/snacks
- Collects and processes lab samples (blood, urine, and other body fluids)
- Searches subjects and their belonging when entering and leaving the facility
- Inserts IV catheters
- Performs vein ratings
- Dispenses concomitant medications as needed and directed by the Principal Investigator
OTHER SKILLS AND ABILITIES:
- Performs study specific procedures and duties per protocol requirements,
- Restocks supplies
- Assists in training PRN staff and new Full Time staff
- Performs administrative work as needed (copying, filing, filling in CRFS, etc.)
- Ensures that procedures run smoothly and procedure areas are kept clean and uncluttered
- Performs procedures and disposes of contaminated supplies according to OSHA requirements
- Writes staff instructions as directed by the Technical Services Supervisor
- Sets-up and breaks-down procedure areas as needed
- Responsible for requesting, scheduling, and attending any training required for this position.
- Customer service skills and be able to perform duties at a fast pace without errors.
- Good documentation and organizational skills and good attention to detail.
- Willing to perform repetitive tasks.
- Good medical judgment.
- Able to draw blood competently, as observed by the Technical Services Supervisor or Training Department staff.
- Some knowledge and skills in performing technical and laboratory procedures; experience performing phlebotomy, vital signs, ECGs and laboratory procedures.
- Medical equipment as indicated by protocol or standing orders for the care of subjects and completion of study requirements. Office equipment used for communication and general office duties. Laboratory equipment used for the processing of laboratory samples. Food preparation equipment for the use of reheating meals.
Required: Course completion in a state approved paramedic training course. Texas Department of Health Paramedic certification or license. BLS and ACLS certification. Minimum 4 - 6 years of previous related experience including at least 1 year of experience as a paramedic, performing at the ALS skill level.
Preferred: 1 year working as a Lead Medic on an ALS unit for a 911 or private EMS agency. Or 3-5 years working in a clinical setting utilizing ALS skills. Clinical Research knowledge. Associate or Bachelor Degree.
Other: Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, participant contact, attention to detail, frequent interruptions, fluctuations in workload, performing very strict time-dependent procedures, multi-tasking, adaptability, problem solving, and planning ahead in order to avert potential problems.
Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
The Paramedic will have tasks assigned to them each shift, and he/she will be responsible for performing these procedures accurately and on time. It will be the Paramedic responsibility to notify his/her Supervisor if they are not able or are not trained to perform any assigned tasks, or of any other problems while on duty. He/she is responsible for making sound medical judgments that are in the best interest of the subjects, study conduct, and WCT. In the absence of a Full-Time Supervisor, they are also responsible for performing mediation with and between subjects while continuing to ensure smooth study conduct and participant completion. Paramedics are expected to remain calm and be tactful in stressful situations and to be a role model for other staff members. The Paramedic will have a large amount of direct and unsupervised contact with study participants. He/she will be responsible for communicating problems, questions and/or clarifications to his/her Supervisor.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.