Job Title:- Clinical Study Associate Duration:- 12 Months Location:- Tucson AZ 85755
Job Summary
As a Clinical Study Associate (CSA) you are part of the Clinical Services Management team and will support the Clinical Services Project Management Team through a varying packet of tasks linked to Sponsor's Monitoring Visits (Study/site Qualification and Initiation Visits, monitoring Visits, Closure Visits, Ad hoc Visits, Monitoring Ad Hoc requests), and/or Pharma Partner's audit. Your day will be filled with on site administrative tasks to always keep the Sponsor's monitoring visits (before, during and after visits) and /or Pharma Partner's audit requests on Task, on Track and on Time.
Roles & Responsibilities:
The CSA is responsible for the delivery of specific tasks, generally overseen by the study Project and/or Program Managers. The specific tasks are time-sensitive and will be followed up accordingly. The CSA ensures that the activities and tasks are accomplished within the CDx CAP/CLIA Laboratory quality system. Work closely with Quality, CDx CAP/CLIA Laboratory, and Pathologist.
Responsibilities
Calendar Management: Coordinates with applicable functions times for SIV, Monitoring Visits, Closing Visits, and/or Audits times.
Laboratory and/or Study Document Maintenance and Preparation for Auditors: Ensures Delegation of
Authority (DOA) Logs are up to date, applicable personnel listed on DOA have applicable trainings completed, device accountability logs are completed on time, good documentation practices (GDP) is performed by laboratory personnel in paper documentation, device registration study binders are up to date and completed as per study requirements. Works closely with Lab Manager and/or representative to ensure documentation is provided on time (e.g. get from Lab instruments maintenance records, logs, etc) and new personnel are up to date on DOAs.
Supplier Questionnaire Document Management: Completes supplier questionnaire using already captured information, ensures follow-up with applicable functions Subject Matter Experts to complete documents on time. Maintain and manage questionnaire dates and document maintenance. Participates in process improvement initiatives
Qualifications:
Formal Training/Education
Bachelor's Degree, preferably in life sciences, nursing or a related field of study; Business Administration or similar expertise through experience.
Experience Details:
2 years of administrative management, and/or entry-level CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories preferred but not required
Knowledge, Skills, and Abilities
Strong communication skills, proficient in English language, both written and oral
communications; other languages desirable.
Proficient in Microsoft Office (Word, Ecel, PowerPoint) and Google Tools.
Ecellent organizational skills and able to multi-task.
Positive and energetic attitude.
Able to take initiative, be adaptable, and strive in a dynamic environment.
Strong attention to detail and commitment to delivering on time.
Diligent and conscientious.
Ability to work independently and as a team member.
Possesses critical thinking and problem solving skills.
Customer and Project Manager service oriented.
Ability to communicate effectively with various internal stakeholders in a positive and professional manner.
It's a bonus if you have: Eperience in cancer research Have a working knowledge of ICH-GCP guidelines related to clinical trials Worked in global locations.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $21.00/hr.
