Senior Clinical Research Associate
Company: Prometrika LLC
Location: Cambridge
Posted on: May 12, 2022
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Job Description:
Job Description PROMETRIKA is a full-service clinical research
organization (CRO) with extensive experience in clinical
operations, data management, biostatistics, medical writing, and
pharmacovigilance. We---re driven by our passion for the human
aspect of our work and our compassion for the people whose lives
have been improved by the innovations we help bring to market. Our
clients include national and international biopharmaceutical and
medical device companies of all sizes. The Senior CRA has the
primary responsibility of ensuring the rights and well-being of
human subjects are protected, the reported trial data are accurate,
complete and verifiable from the source documents. The Senior CRA
oversees the overall conduct of the trial at their assigned study
site(s) and ensures compliance with Standard Operating Procedures
(SOPs), International Conference on Harmonization (ICH), Good
Clinical Practices (GCP), other applicable federal and local
regulations and guidelines, the company goals and agreed upon
budgets. Project-Related Responsibilities Provide oversight and
tracking of study monitoring activities, inclusive of regional
Clinical Research Associate (CRA) selection and management, trip
report review, and performance of monitoring/co-monitoring
visits/observation visits Contribute to the development of key
study documents in conjunction with Clinical Trial Managers and
other functional area leads (e.g., protocols, model informed
consent forms, case report forms [CRFs], study manuals, clinical
monitoring plans, laboratory manual, pharmacy manual, training
materials and site initiation slide presentation) Participate in
vendor selection, vendor qualification and vendor management for
outsourced clinical operations activities, as required Participate
in quality risk assessments and develop Key Risk Indicators (KRIs),
as well as risk management activities during the study Site
management activities, including but not limited to, site
training/support, overseeing the timely resolution of data entry
queries and missing data, overseeing the timely resolution of site
monitoring findings, tracking of enrollment/patient status
activities, confirming compliance site informed consent procedures,
conduct IP accountability, clinical supplies management, identify
and report protocol deviations Identify and support resolution of
site performance issues related to the study protocol and
ICH/GCP/regulatory compliance, subject recruitment and/or data
entry requirements. Recommend corrective and preventive action
plans (CAPAs) as required and track the timely resolution of agreed
upon actions. Confirm effectiveness of the implemented risk
strategies Perform study site monitoring visits (site
qualification, study initiation, routine monitoring, study
close-out) per the monitoring plan schedule. This includes the
timely sending of confirmation and follow up letters, and the
completion of a high quality, clear visit report for all visits
Perform remote monitoring activities and detection of potential
trends or issues Perform centralized monitoring activities and the
aggregate review of site and study level data. Work with the eTMF
Specialist and Sr. CTA/CTA to develop and maintain Clinical Study
Files (i.e. eTMF). Interface with study sites to ensure that
documentation is complete, accurate, and current. Assist with
recurring eTMF reconciliations and the resolutions of identified
issues, as necessary Assist Safety Management team in the
reconciliation of SAE case management Maintain study specific
tracking via CTMS or other tools Provide trial site updates and
identify risks to project timelines to the Clinical Trial Manager
and/or Lead CRA according to study specific monitoring guidelines,
and in a timely fashion Assist with site investigator grant
reconciliations as necessary Assist Medical Writing department as
needed with quality control checks of clinical study reports and
drafting of safety narratives Achieve department key performance
indicator (KPI) goals for assigned project work. Proactively
identify potential risks to achievement and propose improvement
solutions as necessary Attend project meetings and teleconferences
as per monitoring guidelines May attend and present at the
Investigator Meetings Assist in the preparation for, and
participates in site audits and inspections; assists in responding
to any issues identified within the timeframe specified
Maintain/develop scientific knowledge within the project---s
therapeutic area Maintain effective, collaborative and meaningful
communication between study site(s), clinical team, and the sponsor
to ensure the successful execution of the clinical trial Department
Responsibilities Contribute to Standard Operating Procedures,
manuals, forms and templates to support efficient and compliant
best practices of the department Collaborate on the development and
improvement of CRA relevant department standard budget and proposal
template items, client relations materials and process development
initiatives Collaborate cross-functionally to create procedures
serving the best interest of the entire company Participate in
business development initiatives, such as proposals, requests for
information, bid defenses, capabilities presentations, etc.
Continually identify, recommend and implement innovative process
ideas and technologies to elevate PROMETRIKA---s core competencies
and offerings, with a focus on improving study monitoring
activities and standard processes Train entry-level and/or junior
CRAs Support the onboarding and management of contract CRAs Lead
relevant team trainings and knowledge sharing initiatives
Participate in project and resource assignment decisions, as well
as department recruiting and hiring process Contribute to thought
leadership and knowledge sharing activities Participate in audits
as necessary Perform other duties as required EDUCATION
Bachelor---s degree in a scientific discipline required. Candidates
with a clinical training/licensure (e.g., RN, LPN) with relevant
experience will also be considered EXPERIENCE Minimum of 10 years
of CRA experience required Oncology experience highly preferred
SKILLS Ability to travel as needed (anticipated at 40% - 60% of
time) Excellent written and oral communication skills Excellent
organizational skills and an astute attention to details
Demonstrated ability to function effectively as a study monitor
with limited supervision Prior experience observing and training
junior CRAs, or performing GCP audits, a definite plus Familiarity
with PCs and standard Microsoft Office software applications
Familiarity with Medidata technical tools (e.g. Rave EDC, RCM eTMF,
CTMS, Medical Imaging, TSDV, Patient Cloud, etc.) Physical
Requirements Incumbents generally must be able to, with or without
accommodation, have the proficient use of both sensory
perception/clarity and muscle control/coordination. This may
include vision (near, far, color, glare control), hearing (auditory
attention, sound localization), speech, strength, agility,
dexterity flexibility, steadiness or reaction time.
Keywords: Prometrika LLC, Cambridge , Senior Clinical Research Associate, Healthcare , Cambridge, Massachusetts
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