Senior Clinical Research Associate - Thinknicity

Position Description

Job Number: F2655

Job Title: Senior Clinical Research Associate

Location: Palo Alto, CA

Job Type: Fulltime

Salary: DOE

Contact Details:
· Kristin Clevenger
· (415) 247-7700.
· kristin@thinknicity.com

Eligibility Requirements
· Relocation expenses are not available for this position.
· No resumes from third party agencies representing their own candidates.
· Position cannot entertain candidates requiring visa-transfer or sponsorship.

Thank you.

Job Description
· Coordination of CRA site monitoring
· Coordinates the activities of CRAs whether client employees or contract consultants. Oversees field CRAs, assignments, data monitoring schedules and quality of data capture.
· Reviews site monitoring reports and acts on queries or deficiencies.
· Answers or, as appropriately, triages data-related queries from site personnel, CRAs, or database management personnel.
· Functions as the key point of contact for CRO monitors
· Pre-study Site visits and Site Initiation Visits
· Reviews / QA’s pre-study site visit reports against follow-up letters
· Site monitoring
· Organizes clinical team routine monitoring visits
· Reviews/ QA’s routine monitoring visit reports against follow-up letters and previous reports
· Monitors clinical sites according to the requirements of GCP to supplement and / or QA the activities of the supervised CRAs
· Quality assurance
· Co-monitors with sponsor and in-house CRAs in order to assure site and CRO compliance with GCP guidelines
· Supports external QA / QC function for recurring themes
· Serves as a member of the clinical research team in:
· Protocol design and review
· Preparation and review of CRFs and CRF Completion Guidelines
· Review of DMDQ plans
· Review of clinical study reports for
1. Identification of site-specific issues
2. Completeness
3. Accuracy
4. Congruence with SOPs
5. Congruence with previous and subsequent reports
6. Congruence with relevant follow-up correspondence
· SAE and AE reconciliation process review with Safety Pharmacovigilance Group
· Manage site closure activities
· Manage updates in ICF, regulatory documents to investigators for submission to IRBs

Candidate Requirements
· Bachelor’s degree in a scientific discipline (BSRN preferred)
· At least 7 years CRA experience, including 4years field monitoring, and experience managing a clinical team, including monitors with a sponsor company.
· Prior medical background and familiarity with medical diseases required.
· Experience assisting the management/coordination of phase 2 or phase 3 studies and prior experience in oncology or other complex therapeutic area is highly preferred.
· The position requires excellent interpersonal and oral / written communication skills to effectively facilitate communication between the client, the clinical sites, the client’s data management group and other client consultants.
· Demonstrated organizational and project management skills including a broad understanding of clinical operations, clinical protocol and drug research and development.
· Ability to manage multiple tasks and priorities, and manage projects from start to finish within budgets and established timelines.
· Intermittent travel (15-20%) to client’s clinical research sites of studies being conducted is also required.
· The ideal candidate’s personal characteristics should include an entrepreneurial spirit.
· The individual should be bright, articulate and creative, and possess collaborative, analytical, and leadership skills.
· In addition, the individual should be able to work in a team setting effectively.

How to Apply

Application Instructions / Send a Resume