Clinical Research Associate Contactor

Regulatory and Quality Solutions LLC (R&Q); United States; Remote; USD 70,000 - 95,000; Full time

Job summary

A leading MedTech solutions company is seeking a Clinical Research Associate to support clinical investigations. This remote position requires travel up to 80%. Candidates should have a strong background in clinical monitoring, regulatory compliance, and excellent communication skills. Join a team dedicated to bringing life-changing technologies to patients.

Benefits

Industry leading compensation package

Focus on work-life balance

Ongoing learning and development opportunities

Qualifications

• 3 years of field clinical monitoring experience.
• Current CRA certification preferred.
• Proficient in English, both verbal and written.

Responsibilities

• Monitor clinical investigations and ensure compliance with regulations.
• Prepare and submit documents to Ethics Committees.
• Conduct site management and oversee operational execution.

Skills

Organizational skills

Interpersonal skills

Problem-solving skills

Attention to detail

Communication skills

Education

Bachelor's degree in health profession or life sciences

Tools

Electronic data capture systems

Clinical trial management systems

Microsoft Office Suite

Job description

RQM+ is TheMedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.

Our tailoredsolutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science,comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.

We don’t make MedTech. We make MedTech happen.

1 Year+ Contract

Support the Clinical Project Management team with the implementation and conduct of clinical investigations. Responsible for independent on-site and remote monitoring of clinical investigations. This position is remote. Travel is required up to 80%

Responsibilities:

• Closely collaborate with Clinical Project Management to ensure study is conducted according to Standard Operating Procedures, international (ISO14155 / ICH-GCP) and local regulations and the Clinical Investigation Plan (CIP)
• Identify when site informed consent forms need updates and collaborate with the clinical management team and site personnel to make the updates and submit them to the Ethics Committee/Investigational Review Boards, Competent Authorities (as applicable).
• ·Prepare and submit documents for Ethics Committee/Investigational Review Boards, Competent Authorities (as applicable) initial and follow-up submissions (incl. amendments, renewals, safety and compliance reporting, end of study)
• Collaborate with the project management team to meet data cleaning deadlines (such as database lock) and implement contingency plans, as needed.
• Ensures smooth operational execution of allocated clinical studies by coordinating with cross-functional teams, managing timelines, overseeing site activities, ensuring compliance with regulatory requirements, and addressing any operational challenges that arise.
• Independently implement complete site management, including on-site and remote monitoring visits (incl confirmation, report writing & follow-up letters) in accordance with the Clinical Investigation Plan (CIP), Monitoring Plan, SOPs, international regulations and guidelines (ISO 14155/GCP), and applicable local regulatory requirements.
• Verify compliance with the Informed Consent Process
• Conduct Source Data Verification and Source Data Review of clinical site reported data entries (compare subject and study records with the case report form) to ensure recorded data are accurately represented, complete, verifiable from the source documentation and timely reporting (including adverse event and device deficiency reporting)
• Ensure timely and accurate query resolution.
• Confirm accuracy and maintenance of Investigator/site regulatory documents file.
• Ensure reliability, integrity and traceability of all study documentation, including all Clinical Study Site staff are properly (re-)trained and training is documented, and all Clinical Study Site task delegations are documented on appropriate logs.
• Conduct device accountability to ensure proper storage, dispensation and accountability of investigational products (as applicable).
• Administer CIP and study related training to (new) study site staff during the study.
• Identify potential risks to study timelines and quality, and develop mitigation strategies.
• Ensure sites are audit-ready at all times by maintaining thorough and organized documentation.
• Maintain and collect good quality essential documents for the Trial Master File (TMF).
• Collaborate with Clinical Project Management team and Safety team to ensure timely and accurate safety reporting.
• Identify problems at sites; document action items and protocol deviations, timely resolve issues and escalate as appropriate.
• Prepare and implement site close-out activities (incl confirmation, report writing, follow-up letters and end of study communications) as per Monitoring Plan.
• Provide feedback on site performance for future trial site feasibility/selection.

Requirements:

• Bachelor's degree (or equivalent combination of education and experience) or higher in a health profession, life sciences or biomedical field.
• Current CRA certification (or working towards certification) preferred.
• 3 years of field clinical monitoring experience, experience in medical device studies is a plus; multiple therapeutic areas considered.
• Experience with electronic data capture and clinical trial management systems preferred.
• Experience with post-market studies is a plus.
• Strong organizational, attention to detail, interpersonal and problem-solving skills.
• Excellent verbal and written communication skills (correspondence, reports, etc.).
• Verbal and written proficiency in English.
• Proficient use of Microsoft Office Suite applications.
• Good knowledge of international regulations and guidelines (ISO 14155/GCP), applicable US Federal (CFR) regulations and local regulatory requirements.
• Ability to develop and maintain strong professional relationships.
• Ability to travel up to 80%

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development.Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development.Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development.Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.