Clinical Trial Associate (CTA)
Larimar Therapeutics Inc (Bala Cynwyd, PA) is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases.
Larimar's lead compound, CTI-1601, is being developed as a potential treatment for Friedreich's Ataxia.
Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds.
Position
Summary:
This position reports to the Vice President, Clinical Operations and will be responsible to execute delegated responsibilities related to trial start up, execution and close out.
to expected and specified quality standards.
The CTA will also ensure all trial related activities are in compliance with SOPs, policies, and regulatory requirements.
Responsibilities Provide general administrative support to the Clinical Operations Department and assistance to Clinical Study Manager(s).
CTA supports clinical studies and the Clinical Operations Department in managing various administrative tasks such as the generation of agendas and minutes, maintaining study tracking, and correspondence with the IRB as necessary.
Assists the Clinical Study Manager(s) with CRO/vendor oversight, study-specific documentation review and QC, including review of protocol, ICF, study plans, study reference manuals, case report forms (CRF), etc.
CTA will play a key role in assisting Document Management with implementing TMF specifications, ensuring they align with the program milestones.
The CTA will assist in document filing in the electronic TMF (trial master file) and quality reviews.
CTA will regularly review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and assist the Head of Document Management with developing corrective action plans related to TMF findings.
CTA will participate in continuous improvement opportunities and enhance operational efficiency actively.
Assists with customization of CDA, clinical site contracts & budgets, when applicable.
Assist the CPM and clinical team with Investigator Meeting coordination, activities preparation and generating meeting minutes.
Coordinate document translations, if required.
May participate in training CRO/vendor teams and onboarding new team members.
Contact clinical sites for specific requests (e.
g.
, enrollment updates, missing documentation, meeting arrangements, etc.
when requested).
May assist in the request of study supply materials and shipments for sites and subjects as needed.
May work with the study team, CRA team and sites to collect documents and maintain files.
Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed.
Assists in maintaining training files for study team, as needed.
Other duties may be assigned as required.
PIf8d90d358535-25448-32837649 Recommended Skills Agenda Development Auditing Business Efficiency Business Process Improvement Case Report Forms Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
Larimar's lead compound, CTI-1601, is being developed as a potential treatment for Friedreich's Ataxia.
Larimar also plans to use its intracellular delivery platform to design other fusion proteins to target additional rare diseases characterized by deficiencies in intracellular bioactive compounds.
Position
Summary:
This position reports to the Vice President, Clinical Operations and will be responsible to execute delegated responsibilities related to trial start up, execution and close out.
to expected and specified quality standards.
The CTA will also ensure all trial related activities are in compliance with SOPs, policies, and regulatory requirements.
Responsibilities Provide general administrative support to the Clinical Operations Department and assistance to Clinical Study Manager(s).
CTA supports clinical studies and the Clinical Operations Department in managing various administrative tasks such as the generation of agendas and minutes, maintaining study tracking, and correspondence with the IRB as necessary.
Assists the Clinical Study Manager(s) with CRO/vendor oversight, study-specific documentation review and QC, including review of protocol, ICF, study plans, study reference manuals, case report forms (CRF), etc.
CTA will play a key role in assisting Document Management with implementing TMF specifications, ensuring they align with the program milestones.
The CTA will assist in document filing in the electronic TMF (trial master file) and quality reviews.
CTA will regularly review metrics established for performance, review data quality outputs and audit outputs to identify trends per study and assist the Head of Document Management with developing corrective action plans related to TMF findings.
CTA will participate in continuous improvement opportunities and enhance operational efficiency actively.
Assists with customization of CDA, clinical site contracts & budgets, when applicable.
Assist the CPM and clinical team with Investigator Meeting coordination, activities preparation and generating meeting minutes.
Coordinate document translations, if required.
May participate in training CRO/vendor teams and onboarding new team members.
Contact clinical sites for specific requests (e.
g.
, enrollment updates, missing documentation, meeting arrangements, etc.
when requested).
May assist in the request of study supply materials and shipments for sites and subjects as needed.
May work with the study team, CRA team and sites to collect documents and maintain files.
Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed.
Assists in maintaining training files for study team, as needed.
Other duties may be assigned as required.
PIf8d90d358535-25448-32837649 Recommended Skills Agenda Development Auditing Business Efficiency Business Process Improvement Case Report Forms Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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