ProPharma
Clinical Research Associate
at
ProPharma
ProPharma has improved the health and wellness of patients for 20 years by partnering with biotech, med‑device, and pharmaceutical organizations to bring new therapies to market. We offer end‑to‑end consulting solutions that de‑risk and accelerate drug and device programs.
Essential Functions
Conduct all types of monitoring and co‑monitoring visits for assigned clinical sites, both in person and remote, including initiation, interim, and close‑out visits.
Write and complete monitoring reports per SOP and local regulatory parameters.
Support study start‑up activities overseas (site identification, feasibility, Ethics Committee submission, and other site set‑up tasks).
Create and maintain study‑specific monitoring documentation (trackers, guidelines, plans, templates, site tools, worksheets).
Train site personnel on protocol requirements and source data management.
Review and ensure accuracy, completeness, and integrity of source documents and case report forms.
Manage investigational supplies (inventory, dispensing, reconciliation).
Monitor clinical trials by reviewing site enrollment, protocol deviations, serious adverse events, laboratory abnormalities, and other activities.
Oversee regulatory documentation and provide support for regulatory concerns.
Communicate consistently with clinical sites, investigators, client personnel, and cross‑functional teams.
Participate in meetings and conference calls with internal project teams and sponsors.
Perform other duties as assigned.
Necessary Skills And Abilities
Excellent verbal, written communication, interpersonal, and presentation skills.
Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
Experience with Electronic Data Capture (EDC), CTMS, IVRS, and eTMF.
Knowledge of local regulations, ICH Guidelines, and GCP.
Strong prioritization, planning, and proactive problem‑solving skills with minimal supervision.
Ability to train others and drive project goals.
General understanding of routine project goals within an organization.
Strong organizational skills and attention to detail.
Educational Requirements
Bachelor's degree or equivalent combination of education and experience.
Experience Requirements
At least 3 years as a Clinical Research Associate.
Prior therapeutic experience with Alzheimer's or similar Neurological/CNS therapeutics.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Business Consulting and Services (Industry)
We celebrate our differences and strive to create an inclusive workplace. Applicants are encouraged to bring their authentic selves. ProPharma is an Equal Opportunity Employer.
All applications are personally reviewed, and applicants receive an outcome of their application. We do not rely on AI screening tools.
ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not call or email anyone regarding this posting.
#J-18808-Ljbffr
at
ProPharma
ProPharma has improved the health and wellness of patients for 20 years by partnering with biotech, med‑device, and pharmaceutical organizations to bring new therapies to market. We offer end‑to‑end consulting solutions that de‑risk and accelerate drug and device programs.
Essential Functions
Conduct all types of monitoring and co‑monitoring visits for assigned clinical sites, both in person and remote, including initiation, interim, and close‑out visits.
Write and complete monitoring reports per SOP and local regulatory parameters.
Support study start‑up activities overseas (site identification, feasibility, Ethics Committee submission, and other site set‑up tasks).
Create and maintain study‑specific monitoring documentation (trackers, guidelines, plans, templates, site tools, worksheets).
Train site personnel on protocol requirements and source data management.
Review and ensure accuracy, completeness, and integrity of source documents and case report forms.
Manage investigational supplies (inventory, dispensing, reconciliation).
Monitor clinical trials by reviewing site enrollment, protocol deviations, serious adverse events, laboratory abnormalities, and other activities.
Oversee regulatory documentation and provide support for regulatory concerns.
Communicate consistently with clinical sites, investigators, client personnel, and cross‑functional teams.
Participate in meetings and conference calls with internal project teams and sponsors.
Perform other duties as assigned.
Necessary Skills And Abilities
Excellent verbal, written communication, interpersonal, and presentation skills.
Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
Experience with Electronic Data Capture (EDC), CTMS, IVRS, and eTMF.
Knowledge of local regulations, ICH Guidelines, and GCP.
Strong prioritization, planning, and proactive problem‑solving skills with minimal supervision.
Ability to train others and drive project goals.
General understanding of routine project goals within an organization.
Strong organizational skills and attention to detail.
Educational Requirements
Bachelor's degree or equivalent combination of education and experience.
Experience Requirements
At least 3 years as a Clinical Research Associate.
Prior therapeutic experience with Alzheimer's or similar Neurological/CNS therapeutics.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Business Consulting and Services (Industry)
We celebrate our differences and strive to create an inclusive workplace. Applicants are encouraged to bring their authentic selves. ProPharma is an Equal Opportunity Employer.
All applications are personally reviewed, and applicants receive an outcome of their application. We do not rely on AI screening tools.
ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not call or email anyone regarding this posting.
#J-18808-Ljbffr