JobWatch

25 days old

Clinical Research Manager - RN, CCRM

Kelly Services
Omaha, NE 68182
**Clinical Research Manager - RN, CCRM**


**Direct-Hire, Full Time, Relocation offered for non-local candidates**



**Summary:** The Clinical Research Manager is responsible for providing day to day oversight of the research department. The position acts as a liaison between Physicians, Administrator and research staff. This person will be responsible for tasks that relate to the operations and management of clinical trials. The Clinical Research Manager will continue to work as a research coordinator in assisting and monitoring patients on a daily basis.



**Responsibilities:**




+ Assist with the review of study protocols and provide recommendations to study director/supervisor on technical and logistical aspects of protocol.

+ Assist in preparing responses to both internal and external quality assurance audits.

+ Assist the Administrator and study technicians in the execution of all study-related activities required across all studies including the schedule of daily work and technical staff.

+ Promote inter-and intra-departmental communication in order to facilitate and maximize performance associated with research projects. Serve as liaison between administration and research team.

+ Provide leadership, technical guidance, and serve as a mentor to new staff.

+ Contribute to department operations improvement in areas such as SOP revisions, department inspections, and equipment maintenance.

+ Assist in rescheduling activities across studies as necessary to meet the needs of all ongoing studies.

+ Provides guidance in the day to day activities of limited assigned departmental employees to ensure accurate, high-quality work, and adherence to pertinent departmental policies, practices and procedures SOPs, safety procedures and biosafety protocols .

+ Prioritizes workload of assigned group.

+ Assist in the interview and selection of qualified non-exempt personnel.

+ Assist in the drafting of appropriate personnel action paperwork.

+ Identify training and development needs of assigned staff.

+ Assist in the development, implementation and delivery of departmental training programs; ensure that assigned staff receive departmental orientation and necessary on-the-job training.

+ May maintain group training manual and training records.

+ Assist in monitoring performance of assigned staff.

+ Assist in providing regular coaching and counseling.

+ Assist in the maintenance and communication of departmental systems and SOPs.

+ Ensure that departmental equipment is maintained in good working condition and that departmental area s are maintained in a clean and orderly condition.

+ Serve as a model as it relates to effective time management, communication and utilization of resources.

+ Provide leadership and motivation to departmental personnel.

+ Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

+ Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.

+ Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.

+ Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.

+ Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol s in order to be able to answer all questions pertaining to the study posed during the informed consent process.

+ Coordinates approval of new study agreements and contracts.

+ Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.

+ Completes case report forms. Extracts data from patient charts in a timely manner

+ Responds to data clarification requests in a timely manner.

+ May attend Investigator meetings requiring travel and report pertinent information back to research team members.

+ Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, and sponsoring agency policies and procedures.

+ Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.

+ Maintains records and other documentation of training.

+ Maintains subject screening logs and protocol deviation logs.

+ Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.

+ Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRBs, Regulatory agencies, CROs and sponsors.

+ Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.

+ Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.

+ Ensures that all materials for each clinical trial protocol are available for subject enrollment.

+ Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.

+ Performs specimen processing and shipment of biological specimen duties.

+ Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

+ Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.

+ Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.

+ Other duties as assigned related to the billing practices, policies, and procedures.

+ Must work as a team member and perform actions consistent with established Adult Pediatric Urology & Urogynecology policies and procedures including standards for safety, attendance, punctuality and personal appearance. Perform other duties as assigned.

+ Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.

+ Completes case report forms. Extracts data from patient charts in a timely manner

+ Responds to data clarification requests in a timely manner.

+ May attend Investigator meetings requiring travel and report pertinent information back to research team members.

+ Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, and sponsoring agency policies and procedures.

+ Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.

+ Maintains subject screening logs and protocol deviation logs.

+ Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.

+ Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRBs, Regulatory agencies, CROs and sponsors.

+ Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.

+ Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.

+ Ensures that all materials for each clinical trial protocol are available for subject enrollment.

+ Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.

+ Performs specimen processing and shipment of biological specimen duties.

+ Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

+ Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.

+ Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.

+ Other duties as assigned related to the billing practices, policies, and procedures.

+ Must work as a team member and perform actions consistent with established Adult Pediatric Urology & Urogynecology policies and procedures including standards for safety, attendance, punctuality and personal appearance. Perform other duties as assigned.



Qualifications:




+ Completion of a Registered Nursing Program

+ Five years in a clinical research setting, preferably working as a clinical research coordinator on Industry-Sponsored clinical trials

+ Urology experience preferred

+ CCRC (Certified Clinical Research Coordinator) certificate

+ Registered Nursing License

+ CPR

+ HIPAA Certification a plus, but not required




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

Categories

Posted: 2020-09-28 Expires: 2020-11-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Research Manager - RN, CCRM

Kelly Services
Omaha, NE 68182

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast