Clinical Research Associate
Provepharm in Collegeville, PA
- Industry: Scientific Research - Health/Medicine/Pharmacology
- Type: Full Time
- Compensation: $150,470.00 - 150,470.00 / Year*
Provepharm Inc., a Provepharm Life Solutions company, is seeking an experienced Clinical Research Associate with monitoring experience.
THIS IS NOT A WORK FROM HOME POSITION. It is an office-based position located in Collegeville, PA when not monitoring. There is no paid relocation, therefore candidates residing outside the local area will not be considered.
The Clinical Research Associate will provide leadership within the Clinical Operations organization to oversee the clinical development of new products and new indications for existing portfolio products. The CRA will directly conduct clinical projects as well as assist other Clinical Operations professionals and consultants and strive to deliver high quality, timely and cost-efficient clinical trials for the company. The CRA will interact with Investigators, Key Opinion Leaders and partner research groups to expand the understanding and utility of the company s products.
- Assist with management and administration of clinical research projects: recruiting investigators, negotiating budgets, collecting investigator documentation, site management, "clinical contact," and preparing status reports.
- Identify, initiate, monitor, and closeout clinical investigative sites under supervision from Project Managers and other senior management.
- Maintain study and site documents from study initiation through archival process.
- Assist and manage training of new Clinical Research Associates and ancillary staff.
- Provide ongoing assistance and education of investigational sites in clinical research.
- Update, track and maintain study specific trial management tools/system.
- Ensure patient safety, maintenance of ethical treatment and compliance to study protocols.
- Ensure compliance with local legal requirements, laws and standards.
- Monitor Case Report Forms (CRF/eCRF) for missing and/or implausible data.
- Assist sites with maintaining Good Clinical Practices (GCP).
- Assist with generation and reconciliation of queries to investigation sites to resolve inconsistent, missing, or implausible data.
- Create and review reports/narratives and follow-up on reported serious adverse experiences.
- Assist/facilitate legal review of investigator agreements.
- Assist and manage project budget and investigator site budget/payments, attend project team meetings, plan and attend investigator meetings, and communicate with stakeholders, investigators, and key opinion leaders.
- Create Standard Operating Procedures and Work Instructions as required.
- Generate and track drug utilization, shipment and storage.
- Provide coverage to clinical contact telephone lines.
- Travel as necessary, consistent with project needs.
- Perform other duties assigned by management.
- BS/BA in Life Sciences or RN (preferred).
- 2-3 years pharmaceutical industry with drug development research experience.
- Excellent work ethic: self-starter, problem solver, self-motivated, proactively seeks out new tasks that move project forward.
- Excellent computer skills including demonstrated ability to effectively use MS Word, PowerPoint, Excel, and Outlook.
- Good understanding of Clinical Study related software, e.g., eCRF, IVRS, CTMS, etc.
- Excellent time management and organizational skills; must be flexible and adaptable to changing project priorities, work assignments and deadlines.
- Proven ability to prioritize and multitask in a dynamic environment.
- Strong verbal, written and interpersonal skills.
- Must live a commutable distance to our office in Collegeville, PA.
Associated topics: alcohol test, assay, internship, lab, lab support, lab technician, lab technologist, laboratory tech, laboratory technician, qa
* Estimated salary
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