Job Description
Job Title: CRA/Monitor - PART TIME
MUST RESIDE IN MIDWEST OR WEST COAST
Type: Contract
Contractor Work Model: Remote
Hours: 10-15 hours a week
Contract Length: 12mns Type: W2 or Corp-to-Corp Location: Remote (Midwest or West Coast) Notes: - 2 Studies
- 10 Sites
- 75 patients total
- 3-4 sites with active patients
- Nice to have therapeutic experience in ENT or Allergy (not required)
- Nice to have some study management experience For submission:
- Please provide the number of hours available to work per week.
POSITION SUMMARY
This position is responsible for supporting the company’s clinical operations function in the management of the FDA. This includes working directly with the study team, vendors, and clinical study sites to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/CFR regulatory guidelines, as well as in line with company goals, timelines, and budgets. This position provides input, necessary support, and oversight for the high-quality execution of global clinical trials. This position also provides support for documentation of important clinical trial data, site start-up, and other operational information to ensure a successful clinical trial. This individual will be accountable for executing the operational plan for clinical studies and providing training and other support at the site level according to program timelines and quality targets. The Contract Clinical Research Associate will be a seasoned professional with a background in life sciences and end-to-end clinical operations experience from working within the biotech or pharmaceutical industry. RESPONSIBILITIES?? - Site Selection and Preparation: Support in-house team with site selection as required. Qualify sites to ensure necessary infrastructure to support the protocol, assist in essential startup documentation collection and IRB approval (if requested).
- Site Initiation Visits: Conduct SIVs to ensure the site is ready to start the trial. This includes verifying that all equipment is functional, staff are trained, and regulatory documents are in place
- Ongoing Monitoring & Quality Control: Conduct regular monitoring visits to ensure compliance with the protocol and regulatory requirements.
- Data Verification: Verify the accuracy, completeness, and compliance of study data with the trial protocol and regulatory requirements.
- Issue Resolution: Identify, report, and resolve any protocol deviations or issues related to patient safety or data integrity.
- Documentation: Prepare and maintain trial monitoring reports and correspondence. Assist with ongoing essential document collection, including IRB submission/approval(s) and updated staff documentation, as requested.
- Training: Provide training to site staff on trial protocols, SOPs, and GCP both at start up and throughout the study process.
- Communication: Interact with investigators, site staff and sponsor to foster effective communication.
- Supply Management: Ensure clinical trial supplies are managed and tracked efficiently.
- Adverse Event Reporting: Ensure all adverse events are reported and followed up in a timely manner. Assist in timely reporting and follow-up of Serious Adverse Events in accordance with FDA guidelines. QUALIFICATIONS
- A BA/BS degree in life sciences, nursing or a related field
- At least 3 years of Onsite Clinical Monitoring experience.
- Other clinical operations experience is desirable
- Excellent working knowledge of FDA & ICH/GCP/CFR regulations and guidelines
- Thorough knowledge of monitoring procedures and strong understanding of the clinical trial process
- Experience with pediatric out-patient studies highly desired
- Experience monitoring global clinical trials for a product through all clinical phases of clinical development
- Demonstrated career success as a seasoned CRA, effective organizational skills, excellent verbal and written communication skills and high attention to detail
- Ability to work in a team environment and meet deadlines
- Resourceful, energetic self-starter who can shift between collaboration and execution
- Possess unquestionable integrity with the highest ethical standards
- Willingness and ability to participate in domestic travel, as required
- Valid driver's license System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M-
#LI-
#DI- Ref: #568-Clinical
System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Job Tags
For contractors, Part time, Contract work, Remote work, Local area, Shift work,