What are the responsibilities and job description for the Research Study Assistant position at ELLIGO HEALTH RESEARCH INC?

Job Description

Description : SUMMARY :

The Research Study Assistant plays a key role in assisting with the conduct of clinical trial activities, in

accordance with all applicable regulations governing the conduct of clinical trials. The primary function of the

Research Study Assistant is to support the Clinical Research Coordinators (CRCs) and the broader study team

in the successful execution of clinical trials to achieve study objectives and corporate goals. This role is

responsible for a variety of tasks, including administrative duties, data management / entry, patient interaction

and technical procedures such as phlebotomy, performing ECGs and vital signs. Additional focus is on

specimen collection, specimen handling and transport, specimen processing, lab manual creation, reviewing

lab results and inventory monitoring.

Requirements : ESSENTIAL DUTIES :

Maintain a safe, clean working environment, including infection control requirements
Perform specimen collections, includes venipuncture to pediatric and adult participants
Process specimens received in the laboratory. This task includes specimen transport, handling, sorting, requisition entry, inventory accountability, and reviewing lab results for PI review.
Performing CLIA waived testing such as urine pregnancy testing, urine dip analysis, urine drug screen testing, alcohol testing, Rapid Antigen Testing
Maintain current GCP, HSP, IATA certification
Ensure specimen collection / processing / shipping are performed according to protocol
Complete study training and available for additional duties to support study conduct as needed, which

may include :

Assist with the screening, recruiting and enrollment of research subjects.

Assist in the informed consent process of research subjects

Collect patient / research participant history

Data entry and Management per Good Documentation Practice

Coordinate follow-up care and laboratory procedures

Support the collection and review of required essential study documents and reports. Order

supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.)

Performing vitals, ECG, spirometry

Coordinate protocol related research procedures, study visits, and follow-up care

Develop strong working relationships and maintain effective communication with study team members

Develop strong working relationships with the investigators and staff to build a foundation of trust and respect

Adhere to an IRB approved protocol

Support the safety of research subjects

Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines

Perform other duties as required and / or assigned.

QUALIFICATIONS :

Clear and concise written and oral communication skills to interact effectively with coworkers and study staff (including sponsor / CRO).

Strong organizational skills including the ability to accomplish multiple tasks within established timeframes through effective prioritization of duties and functions in a fast-paced environment.

Ability to recognize and synthesize information

Ability to act and operate independently with minimal daily direction from manager to accomplish objectives

Strong attention to detail and accuracy

Excellent interpersonal and customer relationship skills

Aptitude to work effectively and positively with a team and diverse group of individuals

Basic skill level with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint)

Basic knowledge of medical terminology preferred

EDUCATION AND EXPERIENCE :

Minimum 1 year of experience in healthcare, clinical research, or clinical setting

Associates degree a plus

Certification in phlebotomy, ECGs or similar clinical skills preferred

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Research Study Assistant

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