Senior Clinical Research Associate

　　Kelly Science and Clinical is partnering with one of the largest and well known CROs in the US. We are hiring Sr CRAs and Principle CRAs for direct hire opportunities in several locations. In this role, you’ll discover meaningful work that makes a positive impact on a global scale. Our clients global Clinical Operations team provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. With them, you will help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

　　Ideal candidates will possess two or more years of onsite monitoring experience and have experience monitoring complex therapeutic studies. This position requires overnight travel either regionally or nationally, dependent on business needs.

　　Job Description

　　Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

　　A day in the Life:

　　Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable

　　Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.

　　Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.

　　Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

　　Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls etc.).

　　Facilitates effective communication between investigative sites, the client company and the CRO project team through written, oral and/or electronic contacts.

　　Responds to company, client, and applicable regulatory requirements/audits/inspections.

　　Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

　　Contributes to other project work and initiatives for process improvement, as required.

　　Knowledge, Skills, and Abilities:

　　Effective clinical monitoring skills

　　Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

　　Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents

　　Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

　　Ability to manages Risk Based Monitoring concepts and processes

　　Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

　　Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues

　　Effective interpersonal skills

　　Strong attention to detail

　　Effective organizational and time management skills

　　Ability to remain flexible and adaptable in a wide range of scenarios

　　Ability to work in a team or independently as required

　　Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

　　Good English language and grammar skills

　　Good presentation skills

　　Keys to Success:

　　Education and Experience:

　　Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

　　2+ years of clinical study monitoring experience from a CRO, Sponsor, or Biotech company. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).

　　Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Work Environment

　　Our client values the health and well-being of our employees. They support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

　　Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

　　Able to work upright and stationary for typical working hours.

　　Able to work in non-traditional work environments.

　　Able to use and learn standard office equipment and technology with proficiency.

　　Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

　　May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

　　This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

　　#EX2BIO23

　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.