Clinical Research Associate II
Company: Precision Medicine Group
Location: New York
Posted on: May 3, 2024
Job Description:
Clinical Research Associate II
at Precision Medicine Group (View all jobs)
New York, NY, USA
Position Summary:
The CRA II is a seasoned, experienced professional in monitoring
and site management. Responsibilities will be dependent upon the
type and timing of the program to which the CRA II is assigned and
typically include activities involving start-up and study
implementation, on-site monitoring of clinical research studies as
well as on-going site management. Incumbents work independently as
a study team member.
Essential functions of the job include but are not limited
to:
- Oversees all aspects of study site management to ensure patient
safety is protected, quality of data generated by managed sites
resulting in consistently low query levels and in acceptable
Quality Assurance reports.
- Provides guidance at the site and project level towards audit
readiness standards and supports preparation for audit and required
follow-up actions.
- Updates, tracks and maintains study specific trial management
tools/systems, and status reports.
- If required, manages site start up procedures including the
feasibility and recruitment of potential investigators, preparation
of EC/IRB submissions, collection and review of regulatory
documents, review and adaptation in Patient Informed Consents,
notifications to IRB, EC and regulatory authorities, as
appropriate, translation of study related documentation,
organization of meetings and other tasks as instructed by the
Clinical Trial Manager/Project Manager.
- If required, assists the negotiation of study budgets and the
execution of investigator contracts under directions of Site
Contract Management department/designee.
- Verifies the process of obtaining informed consent has been
adequately performed and documented for each subject/patient, as
required/appropriate. Assesses factors that might affect
subject/patient's safety and clinical data integrity at an
investigator/physician site such as protocol deviation/violations
and pharmacovigilance issues.
- Independently conducts all forms of site visits, including
pre-study/ qualification, initiation, routine monitoring, and
close-out visits, in accordance with the protocol, local laws,
ICH-GCP and Precision SOPs. Prepares and submits for review,
accurate and timely monitoring reports from all site visits
(on-site and remote).
- Documents activities via confirmation letters, follow-up
letters, trip reports, communication logs, and other required
project documents as per SOPs, Clinical Monitoring Plan/Site
Management Plan and client requirements. Supports subject/patient
recruitment, retention and awareness strategies. Enters data into
tracking systems as required to track all observations, ongoing
status and assigned action items to resolution.
- Routinely reviews the Investigator Site File (ISF) for
accuracy, timeliness and completeness. Reconciles contents of the
ISF with the Trial Master File (TMF). Ensures the
investigator/physician site is aware of the requirement of
archiving essential documents in accordance with local guidelines
and regulations.
- Communicates effectively and proactively with both site
personnel and Precision Project and Clinical Trial Management to
relay protocol/study issues including any deviations and implements
necessary actions in response to those issues.
- Develops and maintains good working relationship with
investigators and study staff, serving as an ambassador to promote
Precision high quality and professional image.
- Performs investigational product (IP) inventory, reconciliation
and reviews storage and security. Verifies the IP has been
dispensed and administered to subjects/patients according to the
protocol. Verifies issues or risks associated with blinded or
randomized information related to IP. Applies knowledge of
GCP/local regulations and organizational procedures to ensure IP is
appropriately (re)labelled, imported and released/returned.
- Performs data review activities, including remote EDC CRF and
patient profiles review, query resolution, and assists data
management and clinical data quality personnel to resolve data
discrepancies.
- Identifies and processes Serious Adverse Events according to
the procedures defined by the study team. Also demonstrates a full
understanding of the SAE reporting process.
- Identifies site risks and escalates those to Clinical Trial
Manager/Project Manager with suggested contingencies. Owns the
timely and appropriate resolution of the risk with minimal support
from project team.
- Prepares for and attends Investigator Meetings and/or sponsor
face-to-face meetings. Participates in global clinical
monitoring/project staff meetings (inclusive of Sponsor
representation, as applicable) and attends clinical training
sessions according to the project specific requirements.
- Travels as necessary according to project needs.
- Performs other duties as assigned by management.
Qualifications:
Minimum Required:
- Europe: University degree life science/pharmacy/other health
related discipline or equivalent experience in a scientific or
healthcare discipline or be a licensed health care
professional.
- N. America: 4-year college degree or equivalent experience in a
scientific or healthcare discipline.
- Two (2) years or more as a CRA in either a CRO or
pharmaceutical/ biotech industry or equivalent, relevant experience
and/or demonstrated competencies. Site management or equivalent
experience in clinical research
Other Required:
- Excellent communication and organizational skills are
essential. A team player.
- Evidence of a client focused approach
- Experience using computerized information systems, electronic
spreadsheets, word processing and electronic mail.
- Ability to travel overnight. Up to 60% travel on average, based
on regional requirements. International travel as needed.
- Fluency in English and for non-English speaking countries the
local language of country where position based
Preferred:
- Graduate or postgraduate degree
- Oncology phases preferably in early phases
- Experience monitoring in rare and complex therapeutic
areas
- Experience monitoring EDC trials and EHR records
- Experience in biopharma or relevant therapeutic area
- Relevant site start-up (feasibility, contract negotiations,
submissions) experience for the particular country
- Ability to monitor study sites, with supervision, according to
protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
- Ability to resolve project related problems and prioritizes
workload to meet deadlines with minimal support from
management.
Competencies:
- Exhibits self-motivation and is able to work and plan
independently as well as in a team environment
- Understands clinical trials methodology, including a working
knowledge of protocols and indications being studied
- Demonstrates professionalism as evidenced by punctuality,
ability to deliver on commitments, an understanding of the service
culture and positive interactions with customers and teammates,
including good interpersonal skills
- Collects data of consistently high standard
- Demonstrated ability to conduct formal presentations to a wide
variety of audiences including colleagues, investigative staff, and
clients with a high level of proficiency
- Fluency in English and for non-English speaking countries the
local language of country where position based
Precision is required by law in some states or cities to include a
reasonable estimate of the compensation range for this role. This
compensation range takes into account the wide range of factors
that are considered in making compensation decisions including but
not limited to: skill sets, experience and training, licensure and
certifications, and other business and organizational needs. The
disclosed range estimate has not been adjusted for the applicable
geographic differential associated with the location at which the
position may be filled. At Precision, it is not typical for an
individual to be hired at or near the top of the range for their
role and compensation decisions are dependent on the facts and
circumstances of each case. This role is also eligible for a
discretionary annual bonus, health insurance, retirement savings
benefits, life insurance and disability benefits, parental leave,
and paid time off for sick leave and vacation, among other
benefits.
Reasonable estimate of the current range
$113,000 - $152,900 USD
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy. For CA applicants, please also
refer to our CA Privacy Notice .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision Medicine Group, Jersey City , Clinical Research Associate II, Healthcare , New York, New Jersey
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