Clinical Research Associate/Monitor

LeMaitre Vascular Seeking

Clinical Research Associate/Monitor

 

 

LeMaitre Vascular is a leading global provider of innovative medical devices for the treatment of peripheral vascular disease. We develop, manufacture and market disposable and implantable vascular devices to address the needs of vascular surgeons and interventionalists. The Company is listed on NASDAQ.

 

Summary Monitors clinical studies for sponsor company at participating study sites by performing the following duties.

 

Essential Duties and Responsibilities include the following. Other duties may be assigned.

· The candidate must be experienced in screening study sites, site monitoring, case report forms design, monitoring clinical studies through end of follow-up and monitoring adverse events.  

· Conduct monitoring visits to verify the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.

· Write and develop data tracking forms, informed consent documents, and updating/modifying internal operating procedures.  Prepare and track required documentation from clinical sites. 

· Track data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.

· Monitor clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation.  Ensure resolution of data queries.

· Provide technical assistance to study sites regarding the conduct of clinical research.  Assure regulatory compliance of investigational sites with company FDA GCP and ICH Guidelines.

· Assist in creation and review of study protocols, case report forms, clinical study reports.  Develop guidelines for the collection of clinical data and/or administration of clinical trials; develop guidelines for new protocols.

· Revise, as necessary, clinical trial documentation and standard operating procedures, specifically SOPs for monitoring the clinical trial.

· Perform site evaluation and assist with closeouts visits.

· Maintain frequent contact with and work effectively with investigators and site coordinators.

· Maintain regular contact with relevant internal departments such as regulatory affairs.

 

 

Qualifications

 

To be considered for this job, individual must be willing to travel up to 70-80%.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education and/or Experience

 

Bachelor's degree in a scientific or health-related discipline from four-year college or university required.  Two or more years of relevant clinical research monitoring experience gained working for a CRO or Medical Device company. 

 

Competencies

 

Strong working knowledge of FDA regulations, as well as GCP and ICH guidelines.

 

Proven ability to successfully coordinate projects.

 

Superior interpersonal skills.

 

Ability to juggle multiple priorities/multi-task.

 

Strong organizational and analytical skills.

 

Strong writing/documentation and PC skills.

 

To Apply:

 

Qualified individuals please submit resume and salary history to:

LeMaitre Vascular

Human Resources

63 Second Avenue

Burlington, MA 01803

 

Email: careers@lemaitre.com

www.lemaitre.com