Clinical Research Associate (eCRA)

NAMSA - Remote3.4

Full-time
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NAMSA is a global medical device research organization providing a comprehensive range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs, HCT/P and combination products. NAMSA has breadth and depth in consulting, non-clinical and clinical services with expertise in cardiovascular, orthopedic, ocular, neurologic, gastroenterologic, urologic, combination product and related medical devices. For more than 50 years, NAMSA clients utilize its testing and consulting services to bring safe and effective products to market.

External MRA (eMRA)

Marketing Duties and Responsibilities

Networks with peers in the medical device industry.
Informs manager or marketing colleagues of potential opportunities.
Senior and Principal Medical Research Associate

In addition to the items listed above:
Participates in meetings with prospective clients.
Role-Specific Duties and Responsibilities

Informs MRM of challenging and/or noncompliant investigators/staff.
Supports data management in CRF development, validation rules, UAT, and other reporting/analysis tasks.
Supports the MRM in managing all aspects of a CEC/DSMB.
Reviews and suggests content for clinical SOPs
Conducts remote monitoring visits including, initiation, interim and close-out visits as required per study monitoring plan.
Senior Medical Research Associate

In addition to the items listed above:
Provides input to the site selection process on appropriate/inappropriate sites.
Conducts remote site qualification visits as required per study monitoring plan.
Informs MRM and works to resolve issues related to challenging/frustrated/irate investigators/staff.
Troubleshoots enrollment difficulties.
Assists in preparing sites for audits and in resolving audit action items.
Performs and summarizes literature searches.
Assists MRM with development of human clinical protocol, investigational plan/brochure and study operations development.
Supports MRM in developing SIV agenda, presentation (protocol, GCP, etc.), and other training materials.
Writes a basic clinical study report
Principal Medical Research Associate

In addition to the items listed above:
Reviews onsite visit reports (e.g. SIV, IMV, COV) of teammates and follows up with team members on action items.
Assists with increasingly complex project management activities as delegated by the MRM
External MRA (eMRA)

In addition to the items above for iMRA & eMRA:
Independently performs investigational site qualification, interim and site close-out monitoring visits in accordance with NAMSA Standard Operating Procedures. Completes and writes applicable visit report and follow-up letter. Independently performs site initiation visits including conducting site and study specific training in accordance with NAMSA Standard Operating Procedures. Writes site initiation visit report and follow-up letters. Responsible for collecting and completing associated documentation during visit.
Addresses and closes (whenever possible) site issues/monitoring action items during onsite visits.
Reviews clinical data for completeness, clarity and conflicts. Issues data queries as needed to resolve inconsistencies or obtain additional information during onsite visits.
Reviews Investigator Site Files during onsite visits in accordance with NAMSA Standard Operating Procedure and study monitoring plan. Collects documents for internal site files as needed.
Instructs and educates site personnel on requirements for CRF completion, source documentation, GCP, study protocol, study file management, device management, maintaining blinding, etc. during onsite visits.
Performs clinical device or biologic inventory and accountability per NAMSA Standard Operating Procedure and study monitoring plan.
Responsible for ensuring compliance with all monitoring plan requirements
Responsible for ensuring accuracy, completeness, and timeliness of visit reports, confirmation/follow-up letters.
Responsible for ensuring accuracy and quality of collected documents and timely submission of these documents into the trial master file.
Communicates with investigators during site visits, and via follow-up letters to inform of any issues as well as good performance.
Identifies data trends during onsite visits and effectively communicates trends to iMRA and MRM and site study personnel as appropriate.
Communicates with iMRA (as applicable) on site specific items.
Per Sponsor request, develops monitoring requirements presentation and attends Investigator Meeting.
Travels as needed (typically between 30%-60%) to meet project milestones.
Performs role of iMRA as needed.
Senior Medical Research Associate

In addition to the items listed above:
Supports the development of the clinical monitoring plan and applicable monitoring documents (e.g., reports, letters) with MRM oversight.
Supports the development of the clinical monitoring strategy and troubleshoots issues.
Principal Medical Research Associate

In addition to the items listed above:
Leads the development and writing of the monitoring plan.
Coordinates & communicates scheduling of monitoring visits. Assigns trips and helps to coordinate resources with the MRM. Maintains monitoring schedule.
Qualifications and Skills

Medical Research Associate

Fluency in English and local language, if different, required.
Bachelor’s degree or equivalent experience in a related field, with a minimum 2 years of current monitoring (preferred) and relevant clinical trial experience.
Senior Medical Research Associate

Fluency in English and local language, if different, required.
Bachelor’s degree or equivalent experience in a related field, with a minimum of 3 years of current monitoring and relevant clinical trial experience.
Principal Medical Research Associate

Fluency in English and local language, if different, required.
Bachelor’s degree or equivalent experience in a related field, with a minimum of 7 years of current monitoring and relevant clinical trial experience.
Technical Competencies

Knows and functions under Good Clinical Practices.
Familiar with study design and protocol development.
Familiar with clinical trial processes such as site selection/qualification, site initiation, monitoring, and close-out.
Familiar with clinical data reporting process.
Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel (and to persuade them to do what is needed).
NAMSA is committed to providing equal employment opportunities (EEO) and treatment for every person seeking employment with or employed by our company. The Company will not fail or refuse to hire any individual, discharge any individual, or otherwise discriminate against any individual by reason of a person’s race, color, creed, religion, national origin, sex, disability, age, citizenship, veteran status, genetic information, sexual orientation, marital status, gender identity, or status with regard to public assistance or any other characteristic, status, or condition protected by law. Employment decisions are based solely upon qualifications and merit. We recognize that diversity and inclusion is a driving force in the success of our company.