One of our clients is looking for a talented and highly motivated Clinical Research Specialist II. Please send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title: Clinical Research Specialist II
Pay Rate: $47 to $58.41/Hr.
Duration: 18 months
Location: Orange County, CA (80% Onsite - 4 Days onsite in a week, 1 Day remote in a week)

Shift timing - 1st Shift - 8 AM to 5 PM Pacific time

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Research Specialist

• Ensure trial patients' safety by ensuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, and exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of the study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Planning and executing Clinical research study management activities from startup through to closeout. Collaborating with internal and external partners as well as other cross-functional teams as needed.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
• Provide oversight and support for new, key, designated sites. Responsible for setup, maintenance, and take down of study devices/materials.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from the client to the field sites and through final disposition.
• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements as well as training and proctoring new employees on trial and study-related activities.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Edit/amend informed consent documents.
• Other incidental duties
• Travel up to 15%
• Clinical Research Monitoring
• Clinical Study management
• Study document (protocol, ICF), and CRF (case report form) development
• EDC, CTMS, Veeva/ TMF, SharePoint, MS Office Suite
• Bachelor's Degree or equivalent in Life Sciences or related field
• 3 years experience equivalent learning in a working environment with hands-on Clinical research experience encompassing all aspects of the clinical process
• 3 years experience prior hands-on clinical research experience encompassing all aspects of the clinical process is preferred, including 1) Cardiovascular device trials; and 2) Cath lab, operating room, and/or intensive care unit familiarity
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
• Experience with electronic data capture preferred
• Proven expertise in MS Office Suite, including Word, Excel, and Adobe, and ability to operate general computer software and office machinery
• Demonstrated problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology, and physiology or Business Unit area of expertise
• Understanding of Medical device regulatory requirements and documents, device accountability, and adverse events reporting
• Technical writing skills (protocols, CRF development, study tools)
• Ability to communicate and relate well with key opinion leaders and clinical personnel

Job Type: Contract

Salary: $47.00 - $58.00 per hour

Experience level:

• 3 years

Schedule:

• 8 hour shift

Application Question(s):

• This is a W2 position. Are you ok to work on W2?
• Please provide your email address

Education:

• Bachelor's (Required)

Experience:

• Clinical Research Monitoring: 3 years (Required)
• Clinical Study Management/Study document/protocol/CRF: 3 years (Required)
• EDC/Medidata Rave/OpenClinica/Medrio: 3 years (Required)
• Veeva/ TMF/eTMF/CTMS: 3 years (Required)
• Medical Device/Biomedical/CardioVascular background: 3 years (Required)

Ability to Commute:

• Irvine, CA 92606 (Required)

Work Location: In person