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9 days old

Clinical Research Coordinator (CRC) Manager

Kelly Services
Springfield, MO 65806
**Clinical Research Coordinator (CRC) Manager**


**Summary**


The CRC Manager is responsible for all aspects of conducting clinical trials. He/she is responsible for ensuring strict protocol adherence. He/she is also responsible for ensuring that Food and Drug Administration regulations are met as well as study budgets and time lines.


The CRC is responsible for coordinating and conducting procedures to insure study participants meet protocol inclusion and exclusion criteria. The CRC must write the Informed Consent Form per CFR and discuss and explain the pertinent aspects of this document with potential subjects.


This position is also required to ensure the schedules for patient visits are developed and maintained. In this leadership role, the CRC must work with the other staff members as a team to ensure all procedures and techniques used follow internal SOPs and external regulations and guidelines for participant safety.


Maintaining constant and positive contact with the Sponsors is very important. Progress reports in the forms of email or telephone correspondence or logs must be completed on a regular basis. The CRC must attend sponsor training sessions both on and off site. Following study close-out, the CRC must organize and write the Clinical Summary which is then sent to the IRB and the Sponsor.


This position must also train staff prior to study start and on an on-going basis if necessary, assist with protocol procedures in the clinic as needed and perform Drug Accountability and Dispensing. This position will have up to 7 direct reports and must be on 100% on site.


**Essential Functions**


**Document Preparation**


+ Writes Informed Consent Forms (ICFs) per CFRs. This also requires working closely with the sponsor to ensure all pertinent information is captured in the ICFs and that they are written at a suitable reading level for lay participants.

+ Create new source documents if needed to capture information specified in protocol.

+ Organize and write Clinical Summaries after study completion. Provide copies to the IRB and study sponsors.


**Contact with Sponsors**


+ Relay enrollment eligibility questions from staff to sponsors.

+ Attend protocol training sessions. This includes Initiation Visits and occasionally Investigator Meetings held by the sponsor.

+ Work closely with sponsors to ensure that all study start-up supplies are on-site in a timely manner.

+ Create, complete and maintain screening, enrollment and adverse event logs. These logs must also be sent to the sponsor on a regular basis (typically weekly). Ensure that these logs are filed in the study file following study completion.

+ Ensure sponsors are kept updated on the progress of their study. This includes updates on screening, enrollment, and adverse events.

+ Notify Sponsors of any serious adverse events and/or pregnancies within 24 hours. This notification includes forms which must be completed concerning the event. Forms must be faxed within 24 hours of Bio-Kinetic Clinical Applications being notified of the event.

+ Work with clinical research associates (CRAs) both off and on-site as they review the progress of the study and completion of the source documents and case report forms.

+ Perform study drug accountability with sponsors.


**Quality Assurance and Logistical Planning**


+ Reviews protocols for logistical planning of the clinical procedures as well as data entry

+ Create and review time and event schedules based upon timelines specified in protocols.

+ Review adverse events and other source documents after completion.

+ Ensures that staff is adequately trained on each protocol, specifically highlighting key points.

+ Review medical histories with potential participants for accuracy, completeness and eligibility.

+ Review complete screening packets including medical history, inclusion/exclusion criteria, concomitant medications, physical examinations, vital sign measurements, ECGs, height, weight and laboratory results to ensure potential participants meet eligibility requirements per protocol.


**Contact with Study Participants**


+ Discuss and explain Informed Consent Forms with potential participants during screening visits.

+ Dose study participants with study drug(s) as per protocol and randomization.

+ Collect and discuss adverse events with participants ensuring that participant safety is priority.

+ Perform clinical procedures such as vital sign measurements, ECGs, height and weight measurements, breath alcohol tests, sample processing, etc.


**Study Drugs**


+ Receive study drug as it arrives on-site at Bio-Kinetic Clinical Applications.

+ Log product into the pharmacy and complete drug accountability logs.

+ Perform accountability and maintain accurate logs concerning the disposition of the study drugs.

+ Dispense study drug per protocol and randomization per SOPs.


**Other**


+ Ensure IRB is notified in a timely manner of any serious adverse events, pregnancies or deviations.

+ Possible weekends depending on study schedule, and flexible on work schedule


**Knowledge / Skills / Abilities**


+ Skill in managing ones own time and the time of others.

+ Skill in completing assignments accurately and with attention to detail.

+ Ability to work under pressure and meet close deadlines.

+ Ability to analyze, organize and prioritize work while meeting multiple deadlines.

+ Ability to analyze and prepare documents, reports, and correspondence.

+ Ability to process and handle confidential information with discretion.

+ Ability to review work for accuracy.

+ Ability to work evenings, nights, and weekends as necessary.


**Education / Experience**


+ Bachelors Degree in biology, chemistry or related major.

+ 5 years of CRC experience required

+ Management experience required, 5 years preferred

+ Knowledge of CFR/ICH Guidelines preferred.

+ Knowledge of Microsoft Office.

+ Flexible and open attitude with analytical thinking ability.

+ Excellent written and oral communication and interpersonal skills

+ Willing to relocate


**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: 2021-10-11 Expires: 2021-11-11

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Clinical Research Coordinator (CRC) Manager

Kelly Services
Springfield, MO 65806

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