QuintilesIMS Senior Clinical Research Associate (Oncology, Central) - Novella Clinical in Houston, Texas

Description:

Novella Clinical is seeking a Sr. Clinical Research Associate for a permanent opportunity to cover the Central US region. Candidates must have strong Oncology monitoring experience!

BASIC FUNCTIONS:

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.

SENIOR CRA 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 ESSENTIAL JOB 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.

TECHNICAL CTM 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:

CMDataCleaningReportBySite and CMDataCleaningReportBySubject 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.

• Four+ years 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.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally

• Very limited physical effort required to perform normal job duties

CLASSIFICATION (US):

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

Qualifications:

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) or equivalent amount of education.

• A minimum of four (4) years of monitoring/site management experience is required.

• 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%.

Primary Location:

USA-Missouri-Saint Louis

Other Location(s):

USA-Alabama-Birmingham, USA-Minnesota-Minneapolis, USA-Wisconsin-Milwaukee, USA-Wisconsin-Madison, USA-Nebraska-Omaha, USA-Texas-Houston, USA-Nebraska-Lincoln, USA-Minnesota-St Paul, USA-Alabama-Montgomery, USA-Alabama-Tuscaloosa, USA-Texas-Dallas, USA-Tennessee-Chattanooga, USA-Mississippi-Jackson, USA-Tennessee-Knoxville, USA-Wisconsin-Green Bay, USA-Tennessee-Memphis