Sr Clinical Research Associate - Oncology &Rare Disease (FSP)
Hey you! Yes you reading this ad! Are you ready for the greatest step in your career? Well if you are still reading this it means that on some level you must be interested in a change. Perhaps this is the positive change you need.
Proclinical is currently seeking Senior Clinical Research Associates In Oncology and Rare Disease as part of our FSP model where you will be working full time as a Proclinical employee and be on assignment to one of our premier global clients where you will gain knowledge, not only from your Proclinical cohorts, but from the client team you will be running. How is that for career growth, knowledge from two organizations all wrapped in one position.
This role is a full-time, fully benefited position and part of our growing and highly sought after FSP Model. As a Proclinical employee you will be eligible for Medical, Dental, 401K and eligible for paid time off, including holiday, vacation, sick/personal time and annual performance reviews.
As an Oncology and Rare Disease Senior Clinical Research Associate, you will be responsible for the monitoring of clinical trials and tracking of study progress. You will contribute to the overall management of clinical trials in accordance with the appropriate quality standards including ICH-GCP guidelines, Standard Operating Procedures (SOPs), applicable regulations, rules and guidance. You will be responsible for clinical site start-up, maintenance, and closure activities, including maintenance of study documents.
- Interfaces with study team to ensure timely initiation and completion of clinical trials
- Responsible for the identification, evaluation and qualification of investigators and sites
- May prepare and submit essential document packages to clinical sites required for clinical site initiation. Collects and reviews essential documents received from clinical sites to ensure all required documents are obtained, accurate and complete
- May assist with the preparation, review and submission of all relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs
- Assists with the ongoing management of the Trial Master File (TMF) and/or Investigator Site Files ensuring essential documents are filed appropriately; assists with the file review and reconciliation process in preparation for audits and archival
- Assists with maintaining and updating project-related data in an existing database, e.g. CTMS, eTMF, etc.
- Reviews Patient Information Sheet /Informed Consent Forms (PIS/ICFs) and/or data protection authorizations as required
- Performs on-site monitoring activities of clinical studies and escalates major site issues to the Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in monitoring reports and follow-up correspondence. Site visits and associated tasks are completed with oversight until authorized to be performed independently
- Collaborates with the CTM/PM to ensure study milestones are met, e.g. enrollment, data cleaning, etc.
- Reviews and manages data on site and remotely; resolves issues on a continuous basis to achieve timely database lock targets
- Responsible for escalating study issues to the CTM/PM and/or Line Manager (LM) in a timely manner
- Responsible for training of site staff and communicating directly with investigative sites to provide study direction, answer questions, assess recruitment rates and respond to sponsor requests
- Prepares sites for audit(s) by sponsor or inspection(s) by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses and resolution
May also include:
- Assistance with the translation process of study documents
- Coordination and assistance with investigator/site contract preparation and negotiation
- Coordination and assistance with feasibility studies
- Assistance with processing of clinical investigator payments, study expense reports and other financial items
- Attendance and participation in customer facing meetings
- Assistance in the planning, organizing and executing of project-specific meetings including, but not limited to, client, CRA, and Investigator Meetings
- Conducting CRA assessment visit(s)
- Contributing to local, regional or global initiatives
- Subject matter expert for given system/tool
Skills and Requirements:
- Bachelor's degree in a life science or related field of study; or equivalent combination of studies, nursing qualifications, and/or work experience
- Minimum of 4 years applicable relevant experience, to include independent monitoring
- Oncology and Rare Disease experience is required for this role
- In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules and guidance, as applicable
If you are having difficulty in applying or if you have any questions, please contact Russ Bland at (+1) 267-435-8555 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.