Ref #: 29798

Employment type: Permanent - Full-Time

Location: US - Northeast

Posted: 08-Jun-2021

Description

DOCS is searching for a Sr. Clinical Research Associate for Neurovascular/Cardiovascular Medical Device studies. The Sr. CRA should have 5+ years of Medical Device monitoring experience in Neurovascular or Cardiovascular trials. The position is home-based for someone on the Northeast of the United States. Travel is expected throughout the Northeast.

A Clinical Research Associate is the individual responsible for managing clinical activities at study sites conducting studies for the Medical Device Sponsor, as well as, fostering strong, productive relationships with colleagues within the sponsor. Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between Clinical Operations and study site personnel for the specific clinical projects.

• Verify safety and well-being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices and
regulatory requirements.
• Accountable for study site performance, and providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues.
• Responds to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company
requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and
company regulations, policies and procedures.
• Assists with internal communication of important clinical data and events.
• Support organization of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
• Knowledgeable and compliant with all applicable laws and regulations relating to sponsor business activities, and
Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

Qualifications:

A minimum of a BS Degree is required. A degree in Life Science, Physical Science, Nursing or
Biological Science with at least 5 years of experience is preferred.
Previous clinical research experience required.
Previous medical device monitoring or equivalent experience required - 5+ years medical device monitoring in cardiovascular or neurovascular therapeutic area
Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
Must be able to review surgical charts and understand medical terminology and procedures
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Clinical/medical background – a plus.


DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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#cardiotrials
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