Research Assistant (Medical Assistant)

ADP, Inc.; Corpus Christi (TX); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

401k

Medical, dental, vision

3 weeks PTO

14 paid holidays

Scrub voucher

And more!

Job summary

Summit Clinical Research Solutions is seeking a Research Assistant (Medical Assistant) to support the Clinical Research Coordinator and principal investigator in conducting clinical studies. The role involves handling study documents, regulatory submissions, sponsor liaison, and patient assessments under protocol guidance.

The ideal candidate will have a high school diploma or GED with 2–4 years of related experience, strong communication skills, and proficiency in MS Office.

Qualifications

• Requires high school diploma or GED; 2–4 years related experience or equivalent
• Ability to complete study-related documents and regulatory submissions
• Experience with CTMS or clinical trial workflows is a plus
• Knowledge of FDA/ICH GCP and HIPAA regulations preferred

Responsibilities

• Assist with creation and completion of study documents and new study prep
• Assist with regulatory submissions and maintain regulatory files
• Act as liaison with sponsors
• Prepare for monitor visits as directed
• Create reports as requested
• Complete study assessments with patients including adverse events and vital signs
• Screen and recruit subjects as directed
• Update CTMS as directed
• Coordinate multiple projects with competing priorities
• Interact with physicians, nurses and sponsor representatives

Skills

Oral and written communication

Organized

Attention to detail

Medical terminology

Reading & interpreting documents

Proficiency in MS Office and browsers

Education

High school diploma or GED

Tools

Microsoft Word

Microsoft Excel

Internet Explorer

Google Chrome

Mozilla Firefox

Electronic Case Report Form systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Research Assistant (Medical Assistant)

30+ days ago Requisition ID: 1073

Summary: Assists the Clinical Research Coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), International Council for Harmonization Good Clinical Practice (ICH GCP), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.

Duties and Responsibilities:

• Assists with the creation and completion of study related documents and new study preparation.
• Assists with the completion of regulatory submissions and maintains regulatory files as directed.
• Acts as a secondary liaison with sponsors.
• Assists with the preparation for study monitor visits as directed.
• Creates reports as requested.
• Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
• Assists with subject screening and recruitment as directed.
• Updates Clinical Trial Management Software (CTMS) as directed.
• Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
• Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.

Education/Experience:

High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.

Certificates and Licenses:

• Clinical research certification preferred

Knowledge, Skills, and Other Abilities:

• Ability to demonstrate competence in oral and written communication
• Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Medical knowledge, including medical terminology
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
• Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.

Work Environment and Physical demands:

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

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Perks of working at Summit Clinical Research Solutions:

• 401k
• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
• 3 weeks of paid time off
• 14 paid company holidays
• Scrub voucher (specific positions apply)
• And more!

Summit Clinical Research Solutions is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.