Medical Research Associate jobs in Golden Valley
|Company Name: NAMSA||Location: Golden Valley,||Area Code: Not Mentioned|
Key Skills: medical research associate
|Job Length: Not Mentioned||Functional Area: Not Mentioned||Salary($): Not Mentioned|
|Telecommute: No||Industry Type: Not Mentioned||Travel Required: Not Required|
|Role: Not Mentioned||Career Level: Not Mentioned||Date Posted: Mar 22nd, 2013|
|Employee Type: Not Mentioned|
NAMSA is the premier global CRO providingexpert regulatory, clinical, and compliance servicesto medical device and healthcare product manufacturers. We partner with clients to help bring safe, effective and compliant products to market.At every stage of the product development process, we provide strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.
Medical Research Associate
This position may be located in Sunnyvale, CA or Golden Valley, MN
Primary Duties and Responsibilities:
Independently performs site visits for site screening and CRF monitoring
Completes study and site documentation such as monitoring reports with project manager review.
Follows up on issues found during monitoring visits based on protocol and regulations.
Instructs or corrects study coordinators based on protocol and regulations.
Maintains records to track clinical inventory (devices or biologics).
Coordinates IRB and site communications.
Tracks and maintains required study documents, clinical subject research record files and Trial Master Files.
Assists in developing queries from data review.
Reviews clinical or test data for completeness, clarity and/or conflicts.
May administer study agreements and communicate with investigators.
May assist with human clinical protocols, investigational plan/brochure development and study operations manuals.
Knowledge, Skills and Abilities Required:
High School Diploma with a minimum of 6 years of relevant experience
AA Degree with a minimum of 4 years of relevant experience
Prefer BA/BS or Masters Degree with a minimum of 2 years of relevant experience
Knowledgeable of appropriate FDA regulations, ISO, and MDD requirements.
Ability to establish priority and balance ones own workload.
Ability to speak, read and write fluently in English at the high school (GED) level, including ability to interpret handwriting from site documents.
Ability to use a computer keyboard is required.
Basic word processing and spreadsheet skills.
Vision needs to be sufficient to read documents including drawings and sketches.
Monocular vision and lack of depth perception do not disqualify.
Auditory acuity must permit conversations with key personnel on the telephone and in person.
Other Job Requirements:
Solves routine problems.
Provides interdepartmental support as needed, e.g., copying, document assembly/preparation.
Enters time into accounting database including client billing and administrative time.
Dresses in a professional manner.
Interacts with employees, clients and vendors in a professional and courteous manner.
Follows NAMSA C&C policies and procedures.
Follows written and verbal work direction and priorities from manager.
Keeps managers and project managers informed as appropriate.
All duties and responsibilities require review by manager.
Assesses and pro-actively addresses client needs.
May support estimate and project plan development.
May be involved in professional activities, including speaking engagements.
Travels as required to meet project and sales and marketing objectives.
Physical activities include sitting and standing for various time periods.
Physical requirements are light to medium work for short to medium time periods, however, occasionally lifting up to 10 pounds.
Repetitive stress disorders (carpal tunnel syndrome) and visual fatigue associated with computer use are possible. Efforts to prevent this will be taken.
NAMSA is an Equal Opportunity Employer (EOE) that is committed to providing equal employment opportunity 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 persons race, color, creed, religion, national origin, sex, disability, age, citizenship, veteran status, genetic information, sexual orientation, marital status, 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.