PRN Research Assistant
4 weeks ago
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 environmentMust be able to work overnight, weekend, and some holidays Knowledge of clinical trials and medical terminologyKnowledge of basic Computer Skills: Microsoft Office Suite, including Word PowerPoint, ExcelOther Skills required:Excellent time management and social skillsHighly motivated with a phenomenal eye for detailAbility to maintain a professional attitude through our online workspace (proper email etiquette, willingness to show up to remote meetings, etc.) PreferredBLSOther 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 treatmentSpecialized 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 biologyPreferred AA/AS or BA/BS in life sciences or educational equivalent
Work Environment
Shifts are variable and may be for evening, nights and/or weekendsThis is an office-based position, any out of office activity must be approved Work environment will include hospitals, medical clinics, and other medical institutionsWilling 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 responsibilityReview with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocolReview the protocol summary sheet and the Informed Consent Form for accuracy and clarityDevelop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarityDevelop 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 physicianReview and verify all relevant source documentation in the subject's medical record to confirm study eligibilityReview the protocol, informed consent form and follow-up procedures with potential study subjectsEnsure that the current approved informed consent is signed before subjects are screened and enrolledEnsure that the randomization procedure is followed as per protocol guidelinesDocument protocol exemptions and deviations.Manage study-related activities, subject compliance, and documentation:Ensure adherence to protocol requirementsSchedule subjects for follow-up visitsAssist investigators in assessment of subject response to therapyReview laboratory data, inform investigator of abnormal values and documentReport to primary care provider as appropriateAssess and document subject compliance with medications and visitsCommunicate with pharmacy staff to assure timely and accurate study drug distributionManage administration of investigational therapyMaintain dispensing logs (if allowed)Maintain copies of any documentation for dispensing of investigational products and/or study-related suppliesOversee specimen collection, storage, and shipmentAttend study-related meetings as appropriateCommunicate 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 platformFollow procedures for access and security for electronic data entryReview keyed data for accuracy, as neededSend data to the data collection center on a timely basisMaintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reportsCorrect and edit data as directed and as appropriate.Monitor and report adverse events:Assess, document and record all AEs as outlined in the protocolReport 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 assignedMaintain files and documents as regulations dictatePrepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as requiredEnsure 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 neededAct as contact person before, during and after audits and inspectionsProvide all required documentation to auditorsMake all appropriate corrections as requested by auditorsCoordinate site response to audit/inspection findings.Management of ancillary staff:Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
Night shifts (ex: 5pm-12am, 12am-8am)
Weekends (depending on study)
Holidays (depending on study)
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