Research Assistant

at  Centricity Research

Suffolk, VA 23435, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate30 Nov, 2024Not Specified01 Sep, 2024N/ADecision Making,Interpersonal Skills,Excel,Communication Skills,Foundation,Leadership,Computer Skills,Teamwork,Analytical Skills,Medical Training,Conflict Resolution,Self Confidence,Collaboration,Project Planning,Outlook,Strategic ThinkingNoNo
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Description:

POSITION FUNCTION

The Research Assistant (RA) performs a variety of administrative and clinical activities to assist the Investigators and CRCs in conducting clinical studies. The RA will have a strong understanding of study protocols and will support study activities completely and accurately.

EDUCATION/EXPERIENCE

Minimum:

  • Canada: College/University Degree OR a healthcare / clinical research diploma (or equivalent experience in a healthcare / clinical research setting (dependent on-site requirements for the role)
  • US: HS/GED/ Certified Medical Assistant or other medical training

Preferred:

  • Clinical Research Certificate is preferred

CORE COMPETENCIES/SKILLS

Prerequisite (Essential):

  • Excellent communication skills (verbal and written)
  • Excellent computer skills (MS Word, Excel and Outlook)
  • Attention to detail
  • Ability to manage time efficiently
  • Self-directed
  • Teamwork & Collaboration
  • Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
  • Flexible & Adaptable
  • Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Foundation:

  • Conflict resolution
  • Receptive to feedback
  • Empowering & Developing others
  • Empathy Skills
  • Planning and organizing skills
  • Excellent problem-solving skills
  • Achievement oriented
  • Analytical ability
  • Initiative
  • Decision making

Leadership:

  • Forward thinking
  • Innovative
  • Creative
  • Strategic thinking
  • Self confidence
  • Strong interpersonal skills

Responsibilities:

Protocol and Safety:

  • Ensure the safety and welfare of study participants
  • Conduct the study as per protocol, GCP, and SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals
  • Be knowledgeable of study protocol to ensure all study activities are completed correctly

Recruiting, Screening, and Enrolling Study Participants:

  • Support study participant recruitment and enrollment initiatives (as designated by RM)
  • Ensure proper written informed consent from each study participant prior to participation in the study and maintained during the study

Study Visit Completion:

  • Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator for ongoing visits (screening & randomization visits as designated by RM)
  • Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site
  • Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
  • Obtain all necessary documentation as required by the protocol
  • Timely and accurate completion of source, data, CRFs, queries and CTMS

Safety Reporting & Data Integrity:

  • Collect and report all adverse events and abnormal results to the Investigator, Sponsor, and REB as per protocol and REB requirements
  • Report Serious Adverse Events and other expedited safety events within 24 hours to the Investigator, Sponsor, and REB and complete appropriate follow-up as required
  • Accurately dispense investigational product and other study supplies
  • Document receipt, storage, and maintain inventory of investigational product and other study supplies
  • Perform regular self and peer quality control (QC) checks and other QC tasks as deemed necessary
  • Support CRPs in Investigator Site File maintenance and updating, as required

General:

  • Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
  • Communicate study questions to the Investigators/Research Management/other CRPs
  • Maintain professional relationships with study participants, physicians, industry representatives and vendors of trial management
  • Attend site, company, and sponsor meetings and study trainings
  • Participate in on-call schedule, if required by the site
  • Timely phone, TEAMS and email communication
  • Organize and participate in community and company outreach events as required (expectation 1-2 per calendar year)
  • Assist with remote and in-person monitoring visits
  • Support CRPs in addressing monitor findings, and follow-up
  • Assist the clinical team with paper and electronic filing and archiving
  • Gather, enter,and/or update data to maintain company records and databases as directed
  • Perform specified tasks of Lab Specialist (based on qualification and designation), if required by the site
  • Assist the clinical team with scheduling and coordinating appointments, reminding study participants of their appointments, and checking study participants in and out of their visits
  • Perform role of un-blinded research staff (e.g. Investigational Product dispensation and/or QC), if required by site and protocol
  • Maintain adequate stock of clinical instruments and supplies in exam rooms and lab area, if required by the site
  • Assist in ordering trial and non-trial medications, if required by the site
  • Assist in organizing patient waiting areas, exam rooms, laboratories, medication areas, and storage areas, if required by the site
  • Manage front desk supervision at sites that require this support and serve as backup to Administrative Assistant (in Sites with this position)
  • Assist Research Management and Investigators with any other research tasks as required


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Hospital/Health Care

Pharma / Biotech / Healthcare / Medical / R&D

Health Care

Diploma

Proficient

1

Suffolk, VA 23435, USA