Senior Clinical Scientist / CRA I Consultant

Senior Clinical Scientist I

(Clinical Research/Clin Ops)

Description of Services

• May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.

• As lead, will be responsible for the following:

• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with CD
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
• Sets up/supports SAC, DMC, adjudication committees
• Protocols/amendments – collaborates with medical writer, participates in governance committee review
• Authors protocol clarification letters
• Contributor to study specific documents (e.g., SMP)
• Reviews/updates informed consent
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
• Monitors data issues requiring clinical input
• Monitors central lab reports and other external data for safety and critical values
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Scientific lead on Clinical Trial Team (CTT)
• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
• Coordinates planning of lab, bio specimens and imaging specifications
• Co- authors newsletters with SM
• Participates in Database lock activities
• Collaboratively plans CSRs, CTDs/WMAs with medical writing
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications in SPECTRUM
• Assesses and prepares protocol deviation list for CSR
• Collaborates with medical writing to develop trial results communication for investigators
• Provides scientific assessment for Operational Reviews
• Supports SM/MW activities as needed to achieve CTT deliverables.
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
• May act as mentor to other CSs

Minimum Years of Experience

• Minimum 7 years for BS/BA or 5 years for MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical/bio-tech/CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.
• TA-specific experience required for Oncology.TA specific experience preferred for IDV and GSM
• Indication specific experience preferred
• Experience reviewing and resolving study related data issues such as; issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required
• 2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience required
• Demonstrated oral and written communication skills
• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred.
• Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible.

Educational Requirements

• Degree in Life Sciences

BS/BA/MS/PhD