FSP Senior Clinical Research Associate - Psychiatry
Locations: United States
Time Type: Full Time
Posted On: 14 Days Ago
Job Requisition ID: JR 7081
About ProPharma:
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Essential Functions:
Conduct all types of monitoring and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person and remotely, including evaluation, site initiation, interim, and close-out monitoring visits.
Complete monitoring reports within required SOP and local regulatory parameters.
Perform study start-up activities in accordance with local practice (Ex-US), including site identification, feasibility activities, essential document collection, Ethics Committee submissions, and site set-up activities.
Support the development of study-specific documentation related to monitoring activities, including trackers, monitoring guidelines, source document templates, site tools, and worksheets.
Manage and train site personnel on protocol requirements, source documentation procedures, compliance, and case report form completion requirements.
Review source documents and case report forms for accuracy, completeness, and integrity, and resolve ongoing data issues.
Manage investigational supplies, including preparation, sending, tracking, dispensing, inventory, and reconciliation.
Monitor site enrollment, protocol deviations, serious adverse events, laboratory abnormalities, and overall compliance with study protocols and regulatory requirements.
Review and oversee regulatory documentation for accuracy and completeness, supporting clinical sites with regulatory concerns.
Communicate effectively with clinical sites, investigators, client personnel, and cross-functional teams regarding site management and monitoring activities.
Participate in meetings and conference calls with internal and external stakeholders for project execution.
Perform other duties as assigned.
Necessary Skills and Abilities:
Prior therapeutic experience in CNS Psychiatry, specifically Bipolar Agitation.
Excellent verbal, written communication, interpersonal, and presentation skills.
Proficient in Microsoft Office applications (Outlook, Word, Excel, PowerPoint).
Experience with EDC, CTMS, IVRS, and eTMF systems.
Knowledge of local regulatory requirements, ICH Guidelines, and GCPs governing clinical trials.
Ability to prioritize tasks, plan proactively, and accomplish goals independently with minimal supervision.
Strong problem-solving abilities with a proactive approach to achieving project goals.
General understanding of routine project goals and organizational needs.
Strong organizational skills and attention to detail with excellent workload prioritization.
Educational Requirements:
Bachelor’s degree or equivalent combination of education and experience.
Experience Requirements:
Minimum of 5 years of experience as a Clinical Research Associate.
Commitment to Diversity and Inclusion:
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails regarding this posting.
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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