Kelly Services Clinical Research Associate for Medical Devices in Redwood City, California
Kelly Scientific Resources is the world's most recognized brand in Scientific Staffing with more than 100 locations in the North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. We currently have an exciting opportunity in the San Francisco area as a CRA.
Summary of Responsibilities :
Conduct clinical research activities including execution of clinical trials and research efforts leading to protocol development
Essential Functions :
Development and implementation of clinical protocols, including CRF design and implementation.
Develop and maintain working relationship with clinical sites and manage study progress.
Assist in development of device labeling documents including registration, instructions for use, patient guides, package inserts, and promotional materials.
Develop and maintain working relationship with CRO’s and contract clinical support staff.
Assist in database creation, management and results analysis.
Clinical monitoring duties as needed including:, study monitoring (remote and on-site) and tracking, working with clinicians to ensure adherence to protocol, FDA and GCP guidelines, initiations & close out visits, review case report forms for completeness, legibility and conformity to available source, device accountability, verify completeness of clinical and regulatory documents including IRB approvals and reports, AE documentation and correspondence, track progress of study enrollment, assist in study document preparation, monitoring guide, site regulatory binder and study/site budgets.
Will travel to research facilities on a regular basis throughout the United States and abroad, with trips by air or car, and 20-30% of the week or month to support the department, as needed.
Handle all forms of correspondence and distribution, and allocation of action items in a timely manner.
Develop and implement procedures, files, records, and follow-up systems to ensure administrative processes are managed in a well-organized and timely manner.
May research, monitor, or prepare semi-routine reports or analyses, summarize findings, and make recommendations, to solve administrative problems.
Use computers and other standard business machines and equipment.
Assist in the preparation of regulatory submissions, including IDEs, PMAs, 510Ks, and foreign filings.
- Support other clinical group research activities that may include bench work, literature search and analysis, etc
- Education and Training
A BA/BS degree in Life Sciences, medicine or other technical field or equivalent combination of training and experience is required.
Experience with image acquisition systems and analysis
Strong interpersonal communication skills, both oral and written.
Thorough knowledge of Good Clinical Practices, ICH 6, and Declaration of Helskinki.
Working knowledge of FDA and EU regulatory policies, procedures and requirements.
Knowledge of interventional ENT procedures, physiology and associated medical terminology strongly preferred.
- Required Experience
- 4+ years of related experience in medical/healthcare or technical fields with extensive direct experience executing and coordinating clinical research for medical device, biotechnology or pharmaceutical industry or equivalent combination of related education and experience.
- Essential Skills and Abilities
Self-motivated, out of the box thinker, open to learn
Ability to work independently, using good judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
Must be a friendly, helpful person who enjoys contact with employees and external contacts at all levels; must have the ability to engage people in conversations; and good listening skills.
Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.
Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts.
Requires above average reading, verbal and written communications skills; proficiency in business English and grammar; good arithmetic skills and attention to detail to maintain records and process reports.
Conscientious in matters of personal work organization, assistance to managers in organizational processes, detailed record-keeping, and follow up.
Must be able to multi-task, remain calm, and adapt to the ever-changing requirements of a dynamic company.
Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook required.
Regular and punctual attendance and dependability in meeting commitments and deadlines are essential functions of this position.
Must be available and willing to work flexible schedules, as needed.
Must have the ability to operate an automobile; a good driving record; and a current California driver's license, for occasional errands or meetings with clients, vendors, and other external contacts.
- Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must have the ability to maintain the physical condition, mental attention and abilities, and stamina appropriate to the performance of assigned duties and responsibilities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee frequently will be required to do the following:
Travel independently; and carry equipment and supplies to and from the car, clinical facilities, airports, or other locations.
Change into appropriate hospital attire and comply with any medical facility, airline, or other customers’ health, safety, and/or security procedures.
While performing the duties of this job, the employee is regularly required to sit while working on the computer, sometimes for the majority of the day; type on a computer keyboard; reach with hands and arms; and talk on the telephone. The employee is required to stand; walk; and occasionally stoop or kneel.
Sit or stand, sometimes for prolonged periods: during meetings, while working at a desk, on the phone, and/or on the computer; type on a computer keyboard; and talk on the telephone.
Significant physical abilities include reaching, hand and finger dexterity, walking, talking, and hearing conversations, and visual acuity. Occasionally the ability to lift and/or move up to 25 pounds is required.
The employee is required to coordinate multiple tasks simultaneously; collect, interpret, and/or analyze complex data and information; and perform some repetitive motion activities; work effectively as part of a team; and concentrate on a variety of details when faced with interruptions and changing work priorities.
The mental demands are representative of those that must be met by an employee to successfully perform the essential functions, as described above, including but not limited to: demonstrated ability to anticipate and solve practical problems or resolve issues; reason, calculate figures and amounts; collect data, establish facts, and draw valid conclusions; interpret procedures and policies; and meet schedules in a dynamic and sometimes demanding work environment, while maintaining positive relationships in a team environment.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job in an office environment the majority of the time.
Part time contract role. Up to 20 hours a week.
Please apply now for immediate consideration!
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm