Cancer Center Jobs

Clinical Site Program Manager (In House Monitor)

The University of Kansas Cancer Center

January 12, 2022
Clinical Site Program Manager (In House Monitor)

The University of Kansas Cancer Center is seeking a Clinical Site Manager to be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, and other duties as assigned assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, KUCC Policy and Procedure and research protocols.

Position Responsibilities:

·         Conduct internal and external, as appropriate, monitoring for all investigator-initiated protocols managed by the Clinical Trials Office. This includes remote and risk-based monitoring.

·         Conduct high level review of all clinical trials managed by the Clinical Trials Office, including cooperative groups, community sites, and industry-sponsored.

·         Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry. Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Director.

·         Act as a Quality Assurance resource to clients of the Clinical Trials Office, evaluate problems and provide solutions.

·         Promote a positive work environment that is maintained through open and effective communication.

·         Establish and foster strong relationships and efficient interactions with KU Cancer Center investigators, KUCC study coordinators, the KUMC community, outside site personnel and sponsors.

·         Ensure quality of deliverables for projects of assigned investigators/clients.

·         Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means.

·         Remote and On-Site Monitoring Responsibilities and Assessment of Site Performance:

·         a. Ensure study staff who will conduct the protocol have received proper materials and

instructions to safely enter patients into the study

b. Ensure the protection of study patients by verifying that informed consent procedures

and protocol requirements are adhered to according to the applicable regulatory

requirements

c. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data

collection tools by careful source document review. Monitor data for missing or

implausible data. Ensure timely distribution of monitoring visit reports and any

supplemental documents/reports to all sites as part of our contribution to

the expeditious completion of the study procedures and data collection as well as

building and maintaining relationships between sites and KUCC.

d. Ensure the resources of the funder and KUCC are spent wisely by performing the

required monitoring tasks in an efficient manner according to established SOPs

and guidelines.

e. When traveling will adhere to all applicable policies and guidelines of KUCC including

managing travel expenses in an economical fashion and preparing accurate and timely trip reports.

·         Perform Case Report Form Review. Review case report form, query generation and resolution against established monitoring plan guidelines, with or without direct supervision, on KUCC data management systems.

·         Assist with Administration of Clinical Research Projects (Multi-Site IITs)

·         a. Assist in recruitment/review of investigators, collecting investigator documentation and site management.

b. Update, track and maintain study-specific trial management tools/systems.

c. Generate and track drug shipments and supplies as needed.

d. Attend investigator meetings, project team meetings and teleconferences as needed.

e. Coordinate slot allocation/randomization of study patients across all sites, providing timely study updates as needed to all applicable site personnel.

f. Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties.

g. Assist with site/study audit preparation and follow up on Corrective Action Plan responses as needed, Provide Coverage for Clinical Contact a. Assist project team in clinical coverage via telephone, email, or in-person as required for Multi-Site IITs.

Position Requirements:

Associate’s degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 4 years. 
Previous experience with Clinic Coordination and/or On-site/Remote Monitoring and Risk-based Monitoring. 3 or more years clinical research experience. Knowledge of FDA regulations relevant to drugs, devices, biologics.
Attention to detail with excellent analytical and problem-solving skills. Ability to work effectively under periodic stressful conditions. Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology. Ability to manage multiple tasks and set priorities and meet deadlines. Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment. Excellent organizational and communication skills. Computer literate including Microsoft Word, Excel, Access, CTMS, and EDC systems. Familiarity with clinical management database systems utilizing tables, queries, etc.
Travel required to monitor multi-site IITs and attend national meetings. Off-site travel is variable, but could be 5% – 20%.


Preferred Qualifications:

Bachelors degree. Previous working knowledge and experience with the FDA and Pharmaceutical sponsors. Oncology clinical trials.
Willingness to seek research certifications to further skills in the position. Research certification preferred such as: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible, Collaborative Institutional Training Initiative (CITI) training certification or certification eligible.


KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.
 
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