In-house Senior Clinical Research Associate - Thinknicity

Position Description

Job Number: F2651

Job Title: In-house Senior Clinical Research Associate

Location:

Job Type: Fulltime

Salary/Pay rate: Dependant on experience.

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:
· The Sr. Clinical Research Associate (CRA) will be responsible for initiation, monitoring and other tasks associated with clinical studies.
· The Sr. CRA will be responsible for investigational site management for clinical studies, and will assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports and related study materials.
· Will also provide guidance, clinical trial management and direction to contract CRAs in the field.
· The Senior CRA will actively participate in clinical trial activities from study start-up through closure
· Assist the CPM with vendor management including the CRO (monitoring and data management), central laboratory, and IVRS vendors
· Work with CRO and manage site selection process
· Assist with reviewing and editing study documents such as Study Operations Manual, Study Drug Manual, Project Management Plan, Communication Plan, Monitoring Plan, and Data Management Plan
· Prepare and review study tools such as the Source Document Worksheets and Source Data Verification Worksheets
· Assist with protocol development, study report completion and designing CRF’s
· Accompany CRO CRAs to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
· Order and co-ordinate study supplies
· Develop and maintain tracking tools
· Assist with CRO selection and management of CRO’s and other vendors
· May assist with site budget negotiations
· Plan and participate in investigator meetings
· Assist and support data validation and data clean procedures
· Assure regulatory compliance of investigational sites with SOPs and FDA and ICH guidelines

Candidate Requirements
· BS in the life sciences or health-related field and 5+ years of relevant experience
· Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
· Experience managing CROs and vendors
· Demonstrated ability to work independently and on a team
· Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) and clinical trial software
· Excellent oral and written communication skills, and strong organizational abilities
· Anemia, Diabetes or Renal experience preferred
· Minimal Travel as required by team/study need

How to Apply

Application Instructions / Send a Resume