Planet Pharma · 2 days ago
Senior Clinical Research Associate
South San Francisco, CA
Contract
Hybrid
Mid, Senior Level
$85/hr - $95/hr
4+ years expPlanet Pharma is seeking a Senior Clinical Research Associate to manage clinical aspects of clinical studies. The role involves working with cross-functional teams to ensure compliance with protocols and good clinical practices, while overseeing study management and vendor activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals
Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately
Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed
Helps to oversee aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision
Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed
Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes
Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level
May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection
Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables
Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows
Participates in the development, distribution, review, and tracking of essential trial documents
Strives to ensure timelines and deliverables are met within budget
Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes
Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution
Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review
Liaises internally to forecast and monitor overall drug supply throughout the trial
Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality
Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions
Contributes to the SOP review process and/or other Clinical Operations Initiatives
Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits
Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done
Qualification
Required
Bachelor's degree in a relevant scientific discipline
Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting
MUST HAVE GLP-1, obesity, or Metabolic study experience
A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology
Self-motivated and able to motivate others
Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
Strong attention to detail and ability to prioritize tasks to meet critical deadlines
Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools
Proficiency in Microsoft suite or products such as Word, Excel etc
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase