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Clinical Research Associate, Level II

Company: Olympus
Location: Birmingham
Posted on: November 22, 2021

Job Description:

Working Location: CALIFORNIA, SAN JOSE; Alabama, Birmingham; Alabama, Huntsville; Alabama, Mobile; Alabama, Montgomery; Alaska, Anchorage; Alberta, Calgary; Alberta, Edmonton; Arizona, Flagstaff; Arizona, Phoenix; Arizona, Tucson; Arkansas, Fayetteville; Arkansas, Little Rock; BR, SAO PAOLO; British Columbia, Kelowna; British Columbia, Vancouver; COLORADO, GOLDEN; California, Baldwin Park; California, Burbank; California, Cypress; California, Downey; California, Fresno; California, Inland Empire; California, Irvine; California, Laguna; California, Long Beach; California, Los Angeles; California, Modesto; California, Newport Beach; California, Oakland; California, Ontario; California, Orange County; California, Rancho Cucamonga; California, Redding; California, Riverside; California, Sacramento; California, San Bernardino; California, San Diego; California, San Fernando Valley; California, San Francisco; California, Santa Barbara; California, Santa Clarita; California, South Bay; California, Sunnyvale; California, Ventura; California, West Covina; Canada; College Park, Maryland; Colorado, Colorado Springs; Colorado, Denver; Connecticut, Hartford; Connecticut, New Haven; Connecticut, Stamford; Delaware, Dover; Delware, Wilmington; District Columbia, Washington; FLORIDA, MIAMI; Florida, Clearwater; Florida, Fort Lauderdale; Florida, Fort Myers; Florida, Gainesville; Florida, Jacksonville; Florida, Orlando; Florida, Pensacola; Florida, St. Petersburg; Florida, Tallahassee; Florida, Tampa; Florida, West Palm Beach; Georgia, Atlanta; Georgia, Augusta; Georgia, Macon; Georgia, Savannah; Georgia, Valdosta; Hawaii, Honolulu; Idaho, Boise; Idaho, Idaho Falls; Illinois, Chicago; Illinois, Lombard; Illinois, Peoria; Illinois, Springfield; Indiana, Indianapolis; Iowa, Burlington; Iowa, Cedar Rapids; Iowa, Des Moines; Iowa, Iowa City; Kansas, Kansas City; Kansas, Topeka; Kansas, Wichita; Kennewick, Washington; Kentucky, Lexington; Kentucky, Louisville; Louisiana, Alexandria; Louisiana, Baton Rouge; Louisiana, Monroe; Louisiana, New Orleans; Louisiana, Shreveport; MASSACHUSETTS, LITTLETON; MASSACHUSETTS, SOUTHBOROUGH; MASSACHUSETTS, WALTHAM; MASSACHUSETTS, WESTBOROUGH; MEXICO, MEXICO CITY; MINNESOTA, BROOKLYN PARK; MISSOURI, ST. 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Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day.

Let's inspire healthier lives, together.

Job Description

The Clinical Research Associate (CRA) II is a member of the Clinical Affairs team, responsible for performing activities essential to providing clinical guidance, strategy and support for the evaluation of new technologies and products in clinical trials. CRA II assists in the design, development, organization, implementation and evaluation of scientifically valid clinical research. Effectively coordinates the activities of Clinical research team members and investigators, and ensures compliance with study protocols, applicable regulations, guidance, policies, and procedures.

Job Duties

* Serve as Clinical Study Project Coordinator under the direction of the Clinical Project Manager and/or as the Clinical Affairs representative on assigned project teams and/or Product Development Process (PDP) teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims.* Responsible for clinical study activities and site management for multiple clinical sites for several ongoing clinical studies.* Designs and develops key clinical study documents (e.g. informed consent forms, study specific plans, study master file plan) and participates in preparation of data management plan (DMP); seeks input as needed from cross-functional team members.* Participates in site start-up activities including creation and shipment of the investigator site file, collection of essential regulatory documents, and IRB submission(s).* Prepares for and executes on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled.* Conducts monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines; ensures site compliance to protocol, reviews investigator site file, performs source document verification (SDV), query resolution, and documents adverse events.* Responsible for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross-functional strategies.* Serves as a liaison for clinical trial agreement (CTA) and budget negotiations.* Ensures maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations.* Tracks progress of clinical studies to: budget, study milestones, and deadlines; clearly communicates study updates to management on a regular basis.* Participates in study audits, as applicable.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor's degree in a related field (e.g., biological, medical, public health, physical sciences, engineering).* Minimum five 5 years experience in medical device industry.* Minimum of five 5 years experience in clinical research, with at least three (3) years experience as a Clinical Research Associate.* Ability to travel domestically up to 40% of the time. Some international travel is expected

PREFERRED QUALIFICATIONS:
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Keywords: Olympus, Birmingham , Clinical Research Associate, Level II, Healthcare , Birmingham, Alabama

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