JobWatch

1+ months

Clinical Research Project Coordinator

Kelly Services
Denver, CO 80238
**Clinical Research Project Coordinator**


**Direct Hire**


**100 Percent Remote**


Salary Dependent Upon Experience


**Duties:**


+ Assists principal investigators in the development of local Investigator Initiated protocols by providing clinical and operational expertise as well as review for consistency of events

+ Responsible for assisting principal investigators in the development of the protocol and subsequent amendments for Investigator Initiated Trials to ensure standardization and adherence to the Company, FDA and GCP policies and guidelines for investigator initiated and multi-center trials

+ Works closely with the clinical research managers and staff in the areas where the trials will take place to ensure study as written is feasible for the disease site team; maintains processes that allow smooth transition of study to disease team once open. Perform initial submission of IITs to Protocol Review and Monitoring System (PRMS) and Human Subjects Research (HSR) Portal.

+ Serves as primary contact for trials assigned and as such will be responsible for developing a communication plan as well as trial study manuals, lab manuals and other instructional tools for the clinic teams.

+ Performs administrative and oversight tasks for all participating institutions which may include registration and randomization activities, coordinating regular teleconferences with all participating institutions, compiling data for reporting to DSMC or other regulatory or oversight entity.

+ Communicates with Finance Professional and Contracts Associate to ensure budget and contract progress in line with other study activation activities; escalate as necessary to PI and/or OCRST Program Director.

+ Works with PI and data specialist on development of electronic case report forms for trials utilizing OnCore, REDCap or Advarra databases

+ Delegates and oversees tasks related to Investigator Initiated Trials Program as appropriate to Program support staff or data specialist.

+ Participates in activities related to development of best practices as related to conduct of IITs and multi-center trials.

+ Facilitate site evaluation and feasibility assessments for multi-center Investigator Initiated Trials


**Education:** BS or BA in Biology, Chemistry, Behavioral Science, Science, Health, Nursing or other related discipline.


**Experience** :


Four years of clinical research experience including at least three years of experience with project coordination of clinical trials. For this position, project coordination is defined as management of _the clinical research projects and activities to ensure compliance with protocols and overall clinical objectives_ . This will include directing all aspects of clinical trial team activities for assigned projects with respect to site selection, project plans and tools, trial budget and timeline management, data collection and analysis, quality standards and risk mitigation.


**Substitution** : A combination of education (i.e. Associates degree) and clinical research or project coordination experience can substitute for the degree on a year for year basis.


ACRP, SOCRA or RAC certification is required.


**Preferred Qualifications:**


1. Understanding of medical terminology and technical writing experience

2. Previous mentoring experience

3. Oncology research experience

4. Experience working with investigator-initiated research

5. Experience working in an academic setting

6. Thorough knowledge of ICH/FDA guidelines


**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: 2021-12-20 Expires: 2022-01-27

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Clinical Research Project Coordinator

Kelly Services
Denver, CO 80238

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