Job Title: Clinical Research Assistant 3-USD Location: Remote (with potential to extend and Convert) Duration: 5+ months
Position Summary: The Sr. CRA (study startup) will work under minimal supervision to: • Plan and execute the design and study startup activities of Client-sponsored studies (including Sponsor-Investigator studies). • Works collaboratively with company’s Biometrics, Data Management, R&D, and Regulatory Affairs groups to compile study start up documentation and/or tracking various study documentations. • Act as department representative/clinical startup leader on project teams. • As needed, this role may support site qualification, activation, management, and monitoring.
Essential Duties and Responsibilities: Primary Responsibilities (Study Startup Tasks): • Partner with Program Management, Clinical Science, and Clinical Affairs management to develop and plan clinical studies. • Write/review protocols, and study reports in consultation with stakeholders (R&D, Biostats, Marketing, etc.), Program Management, Clinical Science, Clinical Trial Lead (CTL), and/or Clinical Affairs Manager. • Develop clinical study materials (including, but not limited to, source documentation, ICFs, CRFs, IRB submissions, training slides, etc.) under direct supervision of Clinical Trial Lead (CTL) and/or Clinical Affairs Manager. • In collaboration with Data Management, perform user acceptance testing (UAT) of electronic data capturing (EDC) systems • Assist with developing monitoring plan and conventions for Sponsor-Investigator and Client Sponsored studies. • Maintain organization, preparation and ordering of supplies and equipment required for clinical studies. • Draft clinicaltrials.gov submissions. • Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders. • Act as a study start up lead for multiple studies/projects simultaneously. • Clearly demonstrate understanding of clinical study management/prioritization. • Work independently to manage all clinical tasks and deliverables to meet clinical timeline • Communicate progress updates to Clinical Trial Lead (CTL), Clinical Affairs management, Program Management, and the various functional groups (R&D, Biostats, Clinical Operations). • Maintain thorough understanding of clinical regulations and standards (including changing regulations). • Create and implement regular process improvements. • This position assumes and performs other duties as assigned. • Complete tasks under minimal or no direct supervision.
Required Knowledge/Skills/Abilities: • Extensive experience in all aspects of clinical trial design and execution • Minimum of 5-8 years related experience in a medical device, pharmaceutical, IVD, and/or CRO • Thorough understanding of the processes associated with study preparation and management • Knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations • Technical expert in the various aspects of the clinical evaluation process • Strong interpersonal and communication skills • Excellent organizational skills and attention to detail • Ability to manage multiple priorities
Preferred Qualifications: • Diabetes experience desirable, but not mandatory • Experience in the medical device industry, Pharma, BioTech and/or CRO • Experience in continuous glucose monitoring (CGM) is a plus • Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)
Travel Required: • The job may require travelling up to 25%-30% of the time as needed; some international travel may be required • Candidate Location: Remotely within United States or local to San Diego, California
Functional/Business Knowledge • Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
Scope • Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Judgement • Exercises good judgment in selecting methods and techniques for obtaining solutions. • Normally receives little instruction on day-to-day work, general instructions on new assignments.
Experience and Education Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years’ experience.
Notice to California Applicants: 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.
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. 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: $58.48/hr.
