Job Description
Job Title: CRA - Monitor
Location: Remote
Hours/Schedule: Approximately 30 hours per week but will range between 25 and 40 hours each week
Compensation: $60-65/hr. W2 (DOE)
Type: Contract Overview: - It’s a combo of field monitor CRA as well as some site-set up and other in-house CRA kind of work but can be done wherever. In other words, no office requirement. There will be 25 sites that need set up and will start seeing patients.
POSITION SUMMARY This position is responsible for supporting the company’s clinical operations function in the management of the FDA required pediatric trial in chronic sinusitis. 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). Anticipated number of sites is ~25 (all US); responsibility for selected sites will be divided between 2 CRAs.
- Site Initiation Visits: Conduct SIVs to ensure the site is ready to start the trial .
- 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
Ref: #568-Clinical
Job Tags
Contract work, Shift work,