Performs study-related clinical and laboratory procedures while ensuring the integrity of the studies and the safety and well-being of human subjects. Assists in study-specific data entry needs, as well as other activities related to the operational conduct of a trial, supporting in multiple departments such as Screening, Laboratory, Clinical Research Coordination, and site operations in general.

Performs duties in accordance with ProSciento’s values, policies, and procedures.

DUTIES AND RESPONSIBILITIES:

• Understands the main objectives of each ongoing study and the study procedures for which he/she will be responsible.

• Demonstrates proficiency at performing clinical procedures such as (but not limited to) vital signs, ECGs, phlebotomy, and sample processing, as required in protocol Schedule of Events (SOE) from First Visit (Screening) through Last Visit (Follow-up)
• Demonstrates proficiency in documenting observations and study procedures following Good Documentation Practices (GDP) in source documents.
• Participates in day-to-day clinical and laboratory activities and procedures, ensuring efficient workflow, appropriate collection and management of research subjects’ data and laboratory samples, and adequate care and treatment of research subjects.

• Supports with COVID-19 sample collections, testing, and procedures.
• Provides lab support including kit preparation, sample labeling, specimen preparation, sample inventory, appropriate storage, and specimen shipping, and helps to resolve laboratory requisition or sample queries from reference labs.
• Serves as point of entry for all specimens coming to the laboratory. This entails processing all specimens, completing requisition forms, shipment of samples, and logging in samples on laboratory tracking logs according to procedures provided in study protocols and manuals.

• Assists in the transcription of study data from source documents to Case Report Forms (CRFs)/ (eCRFs).

• Assists with receipt and inspection of protocol specific supplies and with ordering and stocking of general materials and equipment, and assists with inventory and stocking of laboratory, clinical, and office supplies and consumables.

• Understands and demonstrates proficiency in appropriately responding to medical emergencies on site. Understands and complies with Good Clinical Practices (GCPs), particularly those regarding the protection of human subjects and integrity of clinical trial data.
• Understands and complies with ProSciento Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Participates as requested in ProSciento Continuous Quality Improvement (CQI) process.
• Flexibility to work mornings, evenings, and/or overnight shifts as needed.
• Attends and participates in all required training activities.

• Assists with Recruitment duties and responsibilities as requested.

JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:

Qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

High school diploma or general education degree (GED) as well as experience as a Medical Assistant, EMT, LVN, Phlebotomist, Foreign Medical Graduate (FMG), or Corpsman in a clinical or laboratory setting and/or equivalent combination of medical education, training, certifications, and/or experience.

KNOWLEDGE, SKILLS, AND COMPETENCIES REQUIRED

Skills, Knowledge, and Abilities: 

Able to perform basic clinical procedures correctly including vital signs, ECGs, and sample processing. Demonstrates initiative and problem-solving skills. Able to respect subject confidentiality and blinding procedures. Understands medical terminology and calculations. Demonstrates a strong attention to detail with superior organizational skills. Under general supervision, exercises judgment in accordance with well-defined policies, procedures, and techniques. Able to self-monitor progress and complete assigned tasks independently.

Competencies:

• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
• Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer resources.
• Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend a broader range of activities.

Certificates and Licenses:

• Basic Life Support (BLS) certification is required and may be provided by the company. GCP training is required and will be provided by the company.

Language Skills:

• Must be proficient in both verbal and written English. Able to communicate effectively with both employees and management. Ability to read and interpret documents such as safety rules, WIs, SOPs, medical terminology, and procedure manuals.

Math Skills:

• Able to add, subtract, multiply, and divide in all units of measure using whole numbers, fractions, and decimals. Able to compute rate, ratio, and percentage and to draw and interpret bar graphs.

Reasoning Skills: 

• Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills: 

• To perform this job successfully an individual should have excellent computer skills with working knowledge in the current Microsoft Office Suite as well as Microsoft Windows operating systems.

CONDITIONS OF EMPLOYMENT

• Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.

WORKING CONDITIONS AND PHYSICAL EFFORT

Work Environment:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.