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Research Assistant/Site Administrative Assist

3 months ago

Lévis Quebec, Desjardins, Canada Centricity Research Full time

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.

The Site Administrative Assistant (SAA) will provide professional and efficient service to study participants and the clinical trial industry; coordinate telephone and email communication; complete and verify the accuracy of documents and tracking systems; coordinate relationships with physicians, other healthcare professionals, vendors, and industry representatives; enter, update, and maintain clinical trial database and clinical trial management software.



ESSENTIAL FUNCTIONS


Research Assistant:

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

Study Administrative Assistant:

  • Provide a range of diverse administrative support and activities for the clinical team including but not limited to, organizing, prioritizing, and summarizing the content of incoming materials, correspondence, communications, and email.
  • Schedule and coordinate appointments; maintain appointment calendars; remind study participants of their appointments through all available means
  • Ensure tracking systems (e.g. study participant activity trackers, CTMS visits) are accurate through appropriate daily, weekly, or monthly verification
  • Assist CRPs with maintaining adequate stock of instruments, office supplies and pharmaceuticals and assist in orders as required.
  • Organize and maintain common areas to appear neat and efficient, including reception areas, waiting areas, building entryways, and any other areas that study participants and clients may see
  • Work independently on special non-recurring and ongoing projects at the request of Research Management, which may include planning and coordinating multiple tasks and disseminating information
  • Ensure marketing materials and other informational literature is current and available for visitors and members
  • Serve as point of contact for all copier service issues at site location
  • Train employees on CTMS
  • Deliver daily mail to appropriate parties
  • Forward incoming faxes and any printed items to appropriate parties

EDUCATION/EXPERIENCE


Minimum:

  • US: HS/GED/ Certified Medical Assistant or other medical training
  • Preferred: Clinical Research Certificate is preferred
  • 2 or more years of professional office experience

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

PHYSICAL DEMANDS


  • Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
  • Frequently required to complete work on the computer in a seated position.
  • May be required to lift light boxes (10 - 20lbs).

WORKING CONDITIONS


  • Modern medical office environment or home office environment
  • Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations
  • Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations
  • Some positions may require overnight/weekend hours

BENEFITS


  • Opportunities to work with internationally renowned physicians
  • Comprehensive health benefits, competitive salary
  • RRSP or 401(k) contribution matching
  • Continued opportunities for growth & development; yearly education allowance
  • Paid holiday closures and employee appreciation days off
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