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Sun May 20, 2018 - 4 weeks ago

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Senior Clinical Research Associate, Oncology (Contract, East Coa

Novella Clinical is now hiring for Senior Clinical Research Associate,
Oncology (Contract, East Coast, and Central). Candidates must have Phase I-III
solid tumor/ hematology experience as well as 4+ years of experience monitor clinical
trials as a regional monitor. Please see

job description below.





**BASICFUNCTIONS:**





Participates in the preparation and execution of Phase I-IV
clinical trials. Oversees the progress of clinical investigations by conducting
site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good
Clinical Practices and procedures set forth by Novella and sponsors. Works
closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all
monitoring activities are conducted according to study requirements. The Senior
CRA may also serve in the Lead CRA role.





**SENIORCRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**






Participates
in the investigator recruitment process. Performs site evaluation visits of potential
investigators. Evaluates the capability of the site to successfully manage and
conduct the clinical study.




Collaborates
with the ISSC department to coordinate activities with the site in preparation
for the initiation of the study. Obtains regulatory documentation for
successful implementation, monitoring, and evaluation of clinical trials. Works
with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study
specific documents




Performs
study initiation activities, reviewing with the site personnel the protocol,
regulatory issues, study procedures, and provides training on completion of the
eCRF; monitoring activities and study close-out activities.




Trains
site staff on the EDC system and verifies site computer system.




Assists
in resolving any issues in order to ensure compliance with site file audits in
conjunction with ISSC.




Assures
adherence to Good Clinical Practices, investigator integrity, and compliance
with all study procedures through on-site monitoring visits. Performs
validation of source documentation as required by sponsor. Prepares monitoring
reports and letters per the timelines defined in Novella SOPs by using approved
Novella/sponsor templates and reports.




Documents
accountability, stability and storage conditions of clinical trial materials as
required by sponsor. Performs
investigational product inventory.
Ensures return of unused materials to designated location or verifies
destruction as required.




Reviews
the quality and integrity of the clinical data through (1) in house review of
electronic CRF data and (2) on-site source verification. Works with sites to
resolve data queries.




May
review protocols, eCRFs, study manuals and other related documents, as
requested by the Clinical Trial Manager and/or Lead CRA.




Serves
as primary contact between Novella and investigator; coordinates all
correspondence; ensures timely transmission of clinical data with the study
site and technical reporting, as requested.




Performs
study close-out visits per the study specific Clinical Monitoring Plan
including final investigational product reconciliation and disposition, site
study file reconciliation, data query resolution through to database lock and
resolution of outstanding action items.




Assists
with, and attends, Investigator Meetings for assigned studies.



Authorized to request site
audits due to data integrity concerns.




Attends
study-related, company, departmental, and external meetings, as required.



Ensures internal and
study-related trainings are completed per Novella and/or study timelines; CTMS
should be current at all times with the pertinent site updates/contacts.



Ensures all study
deliverables are completed per Novella and study timelines



Conducts Field Evaluation
Visits and field training of CRA Is, IIs and other Sr. CRAs.



Serves as mentor for
junior CRAs and those new to the company and/or study.



Performs other duties, as
requested.





**LEAD CRA ESSENTIALJOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**





The Lead Clinical Research Associate **may** perform any of the following tasks:






Participate
in the investigator recruitment process. Perform site evaluation visits, as
needed, of potential investigators. Evaluates the capability of the site to
successfully manage and conduct the clinical study.




Collaborate
with the ISSC department to coordinate activities with the site in preparation
for the initiation of the study. Obtains
regulatory documentation for successful implementation, monitoring, and
evaluation of clinical trials. Works with ISSC and site staff to obtain
regulatory (IRB/IEC) approval of study specific documents




Perform
study initiation activities, reviewing with the site personnel the protocol,
regulatory issues, study procedures, and provides training on completion of the
eCRF; monitoring activities and study close-out activities.




Assists
with, and attends, Investigator Meetings for assigned studies.




Train
site staff on the EDC system and verify site computer system.




Assist
in resolving any issues in order to ensure compliance with site file audits in
conjunction with ISSC.




Assure
adherence to Good Clinical Practices, investigator integrity, and compliance
with all study procedures through on-site monitoring visits. Performs
validation of source documentation as required by sponsor. Prepares monitoring
reports and letters per the timelines defined in Novella SOPs by using approved
Novella/sponsor templates and reports.




Document
accountability, stability and storage conditions of clinical trial materials as
required by sponsor. Performs
investigational product inventory.
Ensures return of unused materials to designated location or verifies
destruction as required.




Review
the quality and integrity of the clinical data through (1) in house review of
electronic CRF data and (2) on-site source verification. Work with sites to
resolve data queries.




May
review draft protocols, eCRFs, monitoring reports and follow-up letters, study
manuals and other prepare study-related documents and templates, as requested
by the CTM and/or PM.




May
serve as primary contact between Novella and investigator; coordinates all
correspondence; ensures timely transmission of clinical data with the study
site and technical reporting, as requested.




Assist
CTM and/or PM in review of project budgets, monitoring costs, potential
overruns and propose/implement cost effective solutions.




Assist
the study management in identifying and generating changes in scope




Perform
study close-out visits per the study specific Clinical Monitoring Plan
including final investigational product reconciliation and disposition, site
study file reconciliation, data query resolution through to database lock and
resolution of outstanding action items.



Authorized to request site
audits due to data integrity concerns.




Attends
study-related, company, departmental, and external meetings, as required.



Ensure internal and
study-related trainings are completed per Novella and/or study timelines; CTMS
should be current at all times with the pertinent site updates/contacts.



Ensure all study
deliverables are completed per Novella and study timelines



May conduct Field
Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.



Serve as mentor for junior
CRAs and those new to the company and/or study.



Participate in the
performance appraisal program by providing timely and accurate feedback
regarding the performance of a perspective CRA.



Review and approve CRA
travel expenses and time sheets.



Perform other duties, as
requested.





**TECHNICALCTM ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**





The Technical CTM **may**
perform any of the following tasks for oncology studies:






Create
master tracker(s) to house information generated from various reports such as:



_CM_Data_Cleaning_Report_By_Site_ and _CM_Data_Cleaning_Report_By_Subject_ both Business Objects
reports




Reconcile
patients that have come off treatment and off study




Generate
and review various IL2 reports




Works
closely with CDRC to ensure data is further reviewed and discrepancies
documented.




The
Technical CTM may participate in CDRC review and aid in Patient Profile review,
as necessary.




There
may be additional tracking required as a result of CDRC's review.





**KNOWLEDGE,SKILLS AND ABILITIES:**






Strong
knowledge of clinical research process, including working knowledge of all
functional areas of clinical trials and medical terminology.




Fouryears of oncology experience and/or
medical device.




Experience
in monitoring and/or coordinating clinical trials required.




Excellent
written and verbal communication skills to express complex ideas to study
personnel at research and clinical institutions.




Demonstrated
ability to form strong functional relationships.




Excellent,
presentation, organizational and interpersonal skills.




Ability
to interact with all levels of staff to coordinate/execute study activities.




Ability
to handle several priorities within multiple, complex trials.




Ability
to reason independently and recommend specific solutions in clinical settings.




Able
to mentor other CRAs and co-monitor, as required.




Understand
electronic data capture including basic data processing functions.




Understanding
of current GCP/ICH guidelines applicable to the conduct of clinical research.




Able
to qualify for a major credit card.




Valid
driver's license; ability to rent automobile.




For
the Technical CTM role, the CRA must have a deep understanding of Novella
systems with the ability to learn even more.





**CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:**






Ability
to travel domestically and internationally




Very
limited physical effort required to perform normal job duties





**MINIMUMRECRUITMENT STANDARDS:**






BS/BA/BSc
(or equivalent) in one of the life
sciences or health care background (RPh, RN, etc) and a minimum of four (4) years
of monitoring/site management experience is reqired; or equivalent combination
of education, training and experience.




Computer
literacy and knowledge of electronic data capture required.




Must
possess excellent verbal and written communication, interpersonal, and
organizational skills.




Requires
and ability to work independently, prioritize, and work within a matrix team
environment.




Prior
Clinical Research Organization (CRO) experience preferred.




Prior
project team leadership experience preferred.




Working
knowledge of budget management preferred.




Must
be able to travel domestically and internationally approximately 65%-85%.







**CLASSIFICATION(US):**





This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime compensation.


**Qualifications:**


EEO Minorities/Females/Protected Veterans/Disabled


**Primary Location:**


USA-North Carolina-Morrisville


**Other Location(s):**


USA-California-Anaheim, USA-Virginia-Manassas, USA-Texas-San Antonio, USA-California-Imperial Beach, USA-Texas-Austin, USA-Georgia-Columbus, USA-Ohio-Dayton, United States, USA-Ohio-Columbus, USA-Ohio-Cincinnati, USA-North Carolina-Wilmington, USA-Georgia-Decatur, USA-New York-New City, USA-New York-Rochester, USA-New York-Buffalo, USA-New York-Albany, USA-Ohio, USA-Ohio-Toledo, USA-California, USA-California-San Diego, USA-Georgia, USA-California-Oakland, USA-California-Laguna Beach, USA-Texas, USA-New York, USA-North Carolina, USA-Virginia-Charlottesville, USA-North Carolina-Durham

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