PRN Research Assistant - overnight, weekend, and holidays

Job Title: Part Time Research Assistant 1 - overnight, weekend, and holiday staff **training is done during normal business hours**

Department: Clinical Research

Reports to: Clinical Director

Summary

The role of the part time Research Assistant (RA) is to support the clinical staff and patients. This is a part-time clinic-based position. A RA typically performs a variety of administrative tasks in support of clinical trials and assists in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. The RA will assist the Clinical Research Coordinators (CRC)/Research Nurse in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols FDA Regulations, and ICH/GCP Guidelines. The Research Support Assistant is immediately accountable to the CRC/CRN and works with them and other study team members to meet study-specific goals and timelines and communicates appropriately and effectively with other members of the study team (both internal staff and external collaborators). Assists with the recruiting needs of specific protocols and works with the team to meet these goals. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

To be successful in this role, the RA should be able to recognize logistical problems, and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask and be able to collaborate with various role players. The RA must be able to work independently, be a team player, and proactively problem solve.

Qualifications

• MUST HAVE relevant work experience in a clinical environment
• Must be able to work overnight, weekend, and some holidays
• Knowledge of clinical trials and medical terminology
• Knowledge of basic Computer Skills: Microsoft Office Suite, including Word PowerPoint, Excel
• Other Skills required:
  • Excellent time management and social skills
  • Highly motivated with a phenomenal eye for detail
  • Ability to maintain a professional attitude through our online workspace (proper email etiquette, willingness to show up to remote meetings, etc.)
• Preferred
  • BLS
  • Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy)
  • Specialized knowledge of the unique needs of patients in the assigned therapeutic areas undergoing treatment
  • Specialized knowledge of assigned therapeutic areas as it relates to research and clinical trials.
  • One to two years skill in human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology
  • Preferred AA/AS or BA/BS in life sciences or educational equivalent

Work Environment

• Shifts are variable and may be for evening, nights and/or weekends
• This is an office-based position, any out of office activity must be approved
• Work environment will include hospitals, medical clinics, and other medical institutions
• Willing to wear Personal Protective Equipment (PPE) as required when visiting medical facilities or when working in clinic

Duties and Responsibilities

• Develop management systems and prepare for study initiation:
  • Assess study feasibility in terms of study's impact on site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)
  • Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
  • Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol
  • Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
  • Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity
  • Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
• Screen and enroll study subjects:
  • Review the study design and inclusion/exclusion criteria with the subject’s primary physician
  • Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
  • Review the protocol, informed consent form and follow-up procedures with potential study subjects
  • Ensure that the current approved informed consent is signed before subjects are screened and enrolled
  • Ensure that the randomization procedure is followed as per protocol guidelines
  • Document protocol exemptions and deviations.
• Manage study-related activities, subject compliance, and documentation:
  • Ensure adherence to protocol requirements
  • Schedule subjects for follow-up visits
  • Assist investigators in assessment of subject response to therapy
  • Review laboratory data, inform investigator of abnormal values and document
  • Report to primary care provider as appropriate
  • Assess and document subject compliance with medications and visits
  • Communicate with pharmacy staff to assure timely and accurate study drug distribution
  • Manage administration of investigational therapy
  • Maintain dispensing logs (if allowed)
  • Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
  • Oversee specimen collection, storage, and shipment
  • Attend study-related meetings as appropriate
  • Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.
• Record data and study documentation:
  • Record data as directed using the appropriate media or platform
  • Follow procedures for access and security for electronic data entry
  • Review keyed data for accuracy, as needed
  • Send data to the data collection center on a timely basis
  • Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
  • Correct and edit data as directed and as appropriate.
• Monitor and report adverse events:
  • Assess, document and record all AEs as outlined in the protocol
  • Report serious AEs o the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).
  • Regulatory documentation:
  • Know and understand all regulatory requirements associated with the conduct of the study assigned
  • Maintain files and documents as regulations dictate
  • Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as required
  • Ensure that all required documentation is complete and appropriately filed.
• Management of site activities during audits and inspections:
  • Prepare for quality assurance audits and regulatory inspections, as needed
  • Act as contact person before, during and after audits and inspections
  • Provide all required documentation to auditors
  • Make all appropriate corrections as requested by auditors
  • Coordinate site response to audit/inspection findings.
• Management of ancillary staff:
  • Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).