Job details
Job type full-time
Full job description
The position
The srClinical research associate (srCra) provides support to the clinical operations manager (com)/study lead(s) to manage and track key study deliverablesThe primary purpose of the position is to support the com/study lead in study set-up, execution, and closeout to ensure study deliverables are met and compliance with clinical protocols, their objectives and ich and gcp guidelinesThis is primarily an in-house role.
Responsibilities
Support study lead to execute study milestones against study timelines
Tracking of key deliverables during start-up, study maintenance and close-out; generate, review and distribute reports from internal tracking at requested intervals (site status, enrollment, dosing)
Collaborate with the study lead to develop/review certain study-specific plans and/or processes
Present updates at team meetings as needed (i.e., clinical trial team meeting, project team meeting, investigator meeting, project training, etc.)
Collect and review essential documents from investigational sites
Support ctas with tmf set-up, maintenance, ongoing quality review, and final reconciliation of study documents
Participate in study specific tasks such as investigator identification and site activation
Contribute to the development/review of study specific monitoring plans; track timing/planning of site visits to ensure compliance
Contribute to the development/review of study materials, case report forms (crfs), informed consent documents for clinical studies
Review monitoring visit reports and perform occasional co-monitoring visits with cro cras
Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, delegation of site responsibilities form, site monitoring log, etc.)
Act as cros’ cra/cta first line of contact for study related questions/issues
Work with the cro to arrange and prepare for site qualification visits, site initiation visits and site investigator meetings (as applicable)
Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on clinicaltrials.gov or eu equivalent
Assist study lead with design and preparation of study related materials for the training of cro staff
Assist study lead with oversight of study vendors (cro, drug supply, central lab) as required
Perform remote query and data review as needed to assist cdm
Assist clinical finance and study lead with the review, tracking and management of study specific budgets
Required:
4-year college degree (preferred) otherwise, candidates with a combination of education and relevant experience will be considered
Minimum of five (5) years in clinical research
Minimum of three (3) years onsite monitoring/site management experience
Experience managing/supervising vendors
Thorough understanding of all applicable fda ich- gcp regulations and guidelines
Working knowledge of medical terminology
Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
Proficient in ms office (word, excel, and powerpoint)
Ability to work in a team or independently
Effective interpersonal, written and verbal communication skills
Able to critically evaluate job tasks and the impact on overall study execution
Strong problem-solving capabilities
Effectively collaborates with study team members
Exceptional organizational skills with the ability to multi-task and prioritize
Attention to detail
Ability to work with distributed team members and outside vendors
Occasional travel in us or overseas (<10%)
Preferred:
Cra certification
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