8 days old

Clinical Research Associate

Kelly Services
New Brunswick, NJ 08901
**Clinical Research Associate**

**(CRA II Principle CRA)**

+ **Open to candidates located in the following locations to work from home office: VA, NJ, NY, PA, MA, DE**

+ Hiring all levels of CRA experience including 1+ years to 5+ years of monitoring sponsor initiated trails

+ Regional travel, work from home, direct hire opportunities

Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting opportunities for permanent Clinical Research Associates at various levels to work with one of the largest global CRO in the industry. We are currently hiring CRAs with at least 2 years of experience all the way up to Principle CRAs who have several years of monitoring experience. Our client is regionally aligned so you will support sites within your region vs therapeutically aligned. This opportunity is offering excellent benefits, employee perks and long lasting career path for growth potential in the future.

**Summarized Purpose:**

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.

**Essential Functions:**

+ 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.

+ 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. Performs 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.

+ 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).

+ Facilitates effective communication between investigative sites, the client company and the clients 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 the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.

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

**Knowledge, Skills, and Abilities:**

+ Proven clinical monitoring skills

+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

+ Demonstrated ability to attain and maintain a working knowledge 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 manage Risk Based Monitoring concepts and processes

+ Good 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

+ Good organizational and time management skills

+ Effective interpersonal skills

+ Attention to detail

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

+ Ability to work in a team or independently as require

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

+ Good English language and grammar skills

+ Good presentation skills

**Job Qualification**

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

+ Minimum 1 year of onsite monitoring experience as a traveling CRA supporting sponsor initiated studies to be considered for CRA II. You will be hired into your title depending on years of onsite/remote based monitoring industry experience you have gained.

+ Valid driver's license where applicable.

+ This role requires independent travel that go up to 80% at times, inclusive of traveling in automobiles, airplanes, and trains.

+ _All U.S. new hires must be fully vaccinated before their first day of employment or request an accommodation. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment._


**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** **** **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 worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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** ****

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 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 Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Clinical Research Associate

Kelly Services
New Brunswick, NJ 08901

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