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24 days old

OCRST Research Monitor

Kelly Services
Denver, CO 80238
OCRST Research Monitor (I-II or III)


**This is a remote role**


Level 1 $51,564-$60,000


Level II $51,564-$65,000


Level III $59,299-$68,000


This position will assist with the implementation and coordination of the OCRST Investigator Initiated Trials (IITs) Program at the Cancer Center by participating in protocol development and data monitoring activities. This position will collaborate with other OCRST members, Data Safety and Monitoring Committee staff, sponsor-investigators and clinical research teams to ensure compliance in protocol conduct, patient safety and data integrity for IITs assigned. Data monitoring will include verification of the accuracy, completeness, validity & integrity of all data collected. This position will identify need for and assist in writing policies, procedures or other documentation to support monitoring activities in the Cancer Center.


+ Schedules and coordinates the activities of the Monitoring Program for Investigator Initiated and National Clinical Trials Network trials including multi-center or other complex research studies.

+ Conducts the monitoring reviews of assigned trials including issuing data clarification queries as necessary.

+ Export, review, and validate data exports for consistency to facilitate consistent data and ensure data captured follows the requirements outlined in the protocol.

+ Writes monitoring reports and communicates monitoring results to OCRST management, teams, including Principal Investigators (PIs) and forwards results to DSMC for review.

+ Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to OCRST Monitoring Manager and Program Director as appropriate.

+ Ensures that written procedures are followed and evaluates quality systems, processes, procedures, and protocols for safety and compliance.

+ Participates in developing SOPs, guidance documents or other tools/templates pertinent to monitoring activities.

+ Assists Cancer Center PIs in the development of local IITs by participating in review of protocols for inclusion of relevant data monitoring language.

+ Collaborates with OCRST and other Cancer Center departments and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.

+ Work with the education and development coordinator, as well as the sponsor-investigators on training of CRC and data management staff during site initiation visits and based on topics noted from monitor visits.

+ Participates in review of data collections forms (e.g. case report forms) to ensure alignment with objectives and priorities identified in the protocol.

+ Occasional travel within or out of state required for monitoring activities on multicenter IITs.

+ Participates in ongoing process improvement practices including problem-solving, planning and implementation of identified solutions; assists with establishing program polices or procedures to ensure efficiencies and effectiveness within the OCRST.

+ This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive.

+ The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.


**Qualifications**


Monitor Level I Requirements


Education: BS or BA in biological, medical science, Behavioral Science, Science, Health, Nursing or other related discipline.


**Experience:**


Two years of clinical research experience with a minimum of 1 year relevant work experience in Quality Assurance, Quality Control, or Monitoring functions

OR Three years of clinical research experience as a Clinical Research Coordinator,


\#P2




**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-18 Expires: 2022-08-18

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OCRST Research Monitor

Kelly Services
Denver, CO 80238

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