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10 days old

Clinical Research Associate (Hybrid remote and onsite)

Kelly Services
Boston, MA 02133
**Clinical Research Associate**


Boston, MA


Direct Hire/Salaried


Hybrid- both onsite and remote


\#ACRP


**PURPOSE/SCOPE:** The in-house CRA is responsible for managing various aspects of site management and project management strategies, including but not limited to administration of the CTMS system, study trial master file set up and maintenance, CRO vendor oversight, site feasibility, and start up activities.


**ROLE AND RESPONSIBILITIES**


+ Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.

+ Send, track, and review study-specific and global feasibility questionnaires.

+ Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.

+ Track training information and issue trainings for sites and contacts.

+ Collection of essential documents related to study start-up and review IP release packages.

+ Prepare for and execute Investigator meetings and other site training programs.

+ Assist with creation of start-up plans and templates.

+ Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and company expectations.

+ Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.

+ Accurately enter and manage data within the Clinical Trial Management System (CTMS) by: tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.

+ Participate in co-monitoring activities.

+ Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.

+ Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team

+ Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.

+ Other related duties as assigned to meet departmental and company objectives.


**QUALIFICATIONS AND EDUCATION REQUIREMENTS**


+ A minimum of a BA/BS degree is required.

+ Degree in a health or science major preferred.

+ 2 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.

+ Working knowledge of clinical monitoring responsibilities and procedures.

+ Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.

+ Proficient in Microsoft Office Suite, especially Word and Excel.


**PREFERRED SKILLS**


+ Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.

+ Strong interpersonal, written, and verbal communication skills.

+ Flexible and adaptable to a small business workplace environment


**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)
Posted: 2021-06-11 Expires: 2021-07-15

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Clinical Research Associate (Hybrid remote and onsite)

Kelly Services
Boston, MA 02133

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