SUMMARY:

The Research Assistant (RA) will provide key support to health center and research staff in implementing research opportunities. The RA will be involved in both local logistics of clinical research coordination at PPSLRSWMO, working alongside the research team as well as actively participating in various aspects and components integral to the conduct of clinical research, including recruitment, screening, educating, consenting and assisting in overall clinical study coordination.

 

Under the guidance of the Research Regulatory Compliance Manager, Director of Research, Principal Investigator (PI), and Planned Parenthood Federation of America (PPFA), the Research Assistant shall:

·         Assist with the recruitment and consenting of study patients for various sexual and reproductive health clinical trials

·         Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol (may include working with patient samples including urine, blood and swab specimens).

·         Maintain accurate and timely source documentation and submit case report forms (CRFs) as required for clinical trials.

·         Resolve data queries in a timely manner (within five days of issuance)

·         Provide support in packaging and shipping study samples to testing locations (may involve working with dry ice upon IATA certification obtained).

·         Educate and update health center staff on specific protocols, recruitment strategies and goals, and other necessary information pertinent to a study

·         Monitor health center staff adherence to protocol

·         Prepare site study documents for monitoring visits and be available for those monitoring visits, as appropriate

·         Collaborate with study sponsor(s) and contract research organizations (CROs) as needed to facilitate daily operations and goals

·         Maintain databases/spreadsheets to track study process and research data

·         Recognize and report adverse events/serious adverse events to the Principal Investigator, IRB and sponsors.

·         Participate in audits conducted by study sponsors, CROs, and the FDA

·         Demonstrate excellent customer service to both internal and external clients by working towards a positive outcome with any problems encountered

·         Ability to work scheduled evenings and weekends, as needed. Periodic travel to other affiliates may be required.

·         Other relevant duties as requested by the supervisor.

Bachelor’s Degree in preferred area of study: social work, public health, nursing, psychology, sociology or similar discipline(s). One course in basic statistics or research methods is desired. (In lieu of academic experience, at least two (2) years of applicable experience is desired).

Requires one (1) to two (2) years of related and/or applicable experience plus knowledge of sexual and reproductive health issues.

Prior training and experience in Good Clinical Practices and the Protection of Human Research Subjects preferred.

Must have excellent interpersonal, customer service, communication, typing, and organizational skills.

Willingness and regular ability to travel to all six health centers in the St. Louis metropolitan area.

·        Experience in working under pressure while maintaining the ability to be calm, methodical, and clear.

·        Experience working cross-culturally, with the ability to communicate empathetically, clearly and articulately.

·        Ability to work independently and to manage large amounts of information while meeting deadlines, ethical guidelines and maintaining accurate records.

Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and general internet navigation.

Bilingual in at least English and Spanish, English and Serbo-Croatian, or English and Vietnamese is highly desired.

 

·         Ability to understand, interpret and carry out instructions furnished in written, oral, or diagram form.

·         Ability to deal with problems involving several concrete variables in standardized situations.

 

·         Excellent verbal and written communication and documentation skills.

·         Ability to read and interpret documents such as scientific protocols, academic journal articles, compliance regulations, operating and maintenance instructions, and procedure manuals.

·         Ability to write routine reports and correspondence.

·         Ability to speak effectively with employees in the organization.

·         Bilingual in English and Spanish, English and Serbo-Croatian, or English and Vietnamese is highly desired.

The 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.

 

While performing the duties of this job, the employee is regularly required to use hands and arms to reach, handle, or feel, and complete repetitive action; talk and hear; sit at a desk in front of computer terminal for up to 7 hours/day, and move around the worksite or office, including standing and/or walking for periods of 20-60 minutes. Employees need to be able to use the following equipment on a regular basis: laptop, telephone, calculator and printer. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.

 

PPSLRSWMO maintains a strict policy prohibiting discrimination on the basis of race, color, religion, sex, pregnancy or pregnancy-related conditions, age, sexual orientation, gender identity or gender expression, economic background, national origin, citizenship, disability, marital or relationship status, military service or veteran status, or any other characteristic protected under applicable federal, state or local law. 

 

PPSLRSWMO acknowledges and owns our past and present; therefore, we seek to look inward into how white supremacy continues to show up in our organization. We have a responsibility to create a place of equity and of inclusion, and we commit to dismantling racism and moving the needle to a more equitable workplace.