Innova Solutions is immediately hiring for a CRA/Sr. CRA
Position type: Contract
Duration: 6 months
Location: Redwood City, CA
As a CRA/Sr. CRA you will:
You will work with Clinical Trial Managers to support and manage the company's clinical trials. The Clinical Research Associate will take on a broad range of clinical trial responsibilities and interact extensively with the clinical team, as well as its consultants and CROs. This is a hybrid role.
Education and Experience Requirements:
- Ensure the success of clinical trials through close cooperation with Clinical Operations Managers and CROs.
- Assist in the creation and coordinate approvals of generated clinical trial documentation, including protocols, informed consent forms, and clinical study reports.
- Review of CRO created documents such as monitoring plans and reports, source document worksheets, and case report forms.
- Maintain study tracking logs.
- Build GCP compliance into each trial via assisting CROs and clinical staff site query resolution, minimizing protocol deviations, writing/following SOPs, and auditing study procedures.
- Utilize project management tools (e.g. Outlook, Word, PowerPoint, Timelines, Excel) in order to plan and execute effective meetings with appropriate materials and balance scope and schedule for each trial.
- Work closely with CROs and other vendors to manage study electronic Trial Master Files (eTMFs) from study start up through closeout, including audits as necessary.
- Co-monitoring of CRO CRAs as required to ensure adherence to monitoring plans and SOPs.
- Manage a small number of vendor relationships that may include IWRS providers, safety management CROs, ECG vendors, and investigator meeting planners.
- Assist with Investigator meeting preparations, including the creation of training materials for both CROs and investigative sites, and help coordinate the investigator meeting planning and logistics.
- Support clinical team efforts to contribute to regulatory submissions in the US and globally by reviewing and coordinating approvals of clinical documents.
- Travel may be required; approximately 10% of the time, or about 2-5 business days per month on average.
The ideal candidate will have:
- A BA or BS in biological sciences, nursing, or related field is preferred.
- At least 5 years of progressive clinical operations experience are required.
- Experience monitoring clinical trial sites and experience with oncology and/or diabetes trials and studies using patient reported outcomes are a plus but are not required.
- Thrives in a dynamic start-up environment.
- Flexibility to wear multiple hats as needed.
- Works well in a team environment but can also work independently without significant oversight.
- Strong project management skills.
- Thorough knowledge of GCPs.
- Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
At least 5 years of progressive clinical operations experience are required.
Qualified candidates should APPLY NOW
for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Senior Clinical & Scientific Recruiter
Ron.Tess@innovasolutions.com PAY RANGE AND BENEFITS: Hourly Rate:
Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS:
Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions:
•One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
•ClearlyRated® Client Diamond Award Winner (2020)
•One of the Largest Certified MBE Companies in the NMSDC Network (2022)
•Advanced Tier Services partner with AWS and Gold with MS Website
: https://www.innovasolutions.com/ Innova Solutions
is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at firstname.lastname@example.org or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.