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Job Details

Clinical Research Associate

Company name
ACell Inc.

Location
Columbia, MD

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Profile

Title:

Clinical Research Associate

Department:

Clinical Affairs

Location:

Columbia, MD

Type:

Full-time

Job Summary

The Clinical Research Associate will assist in the development, monitoring, and completion of multiple regulated and post-market medical device clinical trials at all phases of development. This position will involve primary contact with medical professionals, core laboratories, consultants, and CROs involved with the clinical studies. Prior work experience should demonstrate dependability, flexibility, and maturity. Candidate must be positive, even-tempered, and effective in building interpersonal working relationships with various clinical personnel.

Principal Responsibilities

Written critical clinical document development, including SOPs, clinical research study protocols, informed consent forms, clinical research forms, and IRB/IEC submissions and renewals

Assist in the development and distribution of training materials and study notebooks

Assist in the development and management of study-related agreements and budgets

Conduct site visits and investigator meetings

Monitor and visit clinical trial sites to ensure conformance with study protocol

Provide support to clinical investigators and study coordinators to resolve site-related issues

Manage device accountability and distribution to clinical trial centers , as appropriate

Track, collect, and review clinical documentation

Review and report adverse events in conformance with FDA regulations

Coordinate with clinical investigators in the timely completion, submission, and review of CRFs and verify report data against protocol and patient files

Assist in collection and compilation of data for statistical analysis

Maintain a working knowledge of GCP and 21 CFR 812

Assist with additional tasks as assigned by the Senior Director of Clinical Research

Required Education and Experience

B.S./B.A. degree in a science/health care field, a nursing degree, or equivalent combined education

A minimum of 4 years of clinical/scientific research experience or relevant work in the medical device industry

· Familiarity with development of clinical protocols and statistical analysis and report writing is a plus

Required Knowledge, Skills, and Abilities

Strong organization, documentation, and interpersonal skills

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.)

Travel Requirement

25 – 35% travel required as projects evolve

Skills & Requirements

Company info

ACell Inc.
Website : http://www.acell.com/

Company Profile
ACell, Inc. offers the next generation of regenerative medicine through the development and commercialization of unique extracellular matrix (ECM) products to repair and remodel damaged tissues in a broad range of applications. ACell’s patented ECM devices address important clinical needs, providing safe, effective, economical and therapeutic outcomes to the wound care and surgical communities. These devices, trademarked as MatriStem, are appropriate for acute wounds, chronic wounds and various surgical procedures. All MatriStem devices are made in the USA.

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