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.

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
• 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

ENVIRONMENT

This job operates in a professional clinical research office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

The clinical work environment involves exposure to potentially dangerous materials and situations that require extensive safety precautions and may include the use of protective equipment. Additionally, will work with blood or blood-borne pathogens.

Due to potential exposure to blood borne pathogens, 90% of works tasks require prolonged glove wear.

Minimal travel (up to 15%) is required to support the position’s responsibilities.

This is a local, onsite position at a clinical research site with office hours 8:00 am – 4:30 pm. Some flexibility in hours is allowed, must work 37.5 hours each week to maintain full-time status.

Occasional evening or weekend work hours may be required per study specific requirements.

PHYSICAL DEMANDS

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

While performing the duties of this job, the employee is required to:

• Walk/and or stand for 8 hours
• Regularly work at a desk using a computer for prolonged periods.
• Perform repetitive motion with substantial movements (motions) of the wrists, hands, and/or fingers.
• Regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), so others will understand and exchange accurate and timely information.
• Frequently stand/walk, grasp objects, and perform lightly/fine manipulation of objects.
• Occasionally move safely over uneven surfaces.
• Frequently reach/work above shoulders, twist/bend/crouch/stoop/squat, grasp forcefully, lift/carry/push/pull objects that weigh up to 10 pounds and occasionally 25 lbs.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus

ADDITIONAL

Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.

The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.

The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the position’s expectations and responsibilities are met.

Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.

Requirements

• 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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