In-House Clinical Research Associate
Beacon Hill Pharma Bethesda, MD
- Expired: over a month ago. Applications are no longer accepted.
MUST HAVE CLINICAL TRIAL EXPERIENCE TO BE CONSIDERED.
In-House Clinical Research Associate
6 month (approx) temp to permanent
Located in Bethesda
100% Remote for now then you will need to be onsite once office reopens
• Must have experience with using a Trial Master File
1) The most important is someone who already knows regulatory documents.
Usually these are site coordinators, clinical trial assistant associates. We really want someone who already knows these documents (example: 1572s, ML, CVs, IRB approvals etc).
2) Use of trackers, reports, excel are good- needed! +
3) TMF is a plus+ (Veeva Vault specifically a definite +).
· The ideal candidate’s experience with TMF and role as a VV System Administrator.
4) Other + CTM and/or MediData Rave (great if they have)
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties.
Duties may include but are not limited to:
• Assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation.
• Coordinate or assist in distribution of trial-related materials to study sites.
• May assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans.
• Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file held by company or Sponsor/Client.
• Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
• Track essential regulatory documents in a centralized web-based system and/or other database.
• Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems.
Additional position information:
• eTMF & database experience is mandatory and required, this Manager/department completes everything electronically in databases, they do not use paper for any of their job functions
• Nursing background is a plus
• Pharmacy background/education and site investigation a plus
• Individuals who have previously worked at Johns Hopkins is a plus because they have experience managing several sites (some of the IHCRA’s at have up to 17 sites on their caseload)
• Spanish is a plus because some projects have documents that require translation to English
• Attention to detail (signatures where required, dates & times recorded, any additional documentation(s) has been included in submissions, etc., looking for accuracy in documents and documentation submitted for review
• Knowledge of federal regulations, ICH, GCP, FDA, IND & IRB.
• Solid of understanding of what constitutes “essential documents” as they relate to IND trials and the electronic submissions that are required.
• Bachelor’s Degree in life sciences or another health-related field.
• Previous experience with clinical trials /human subjects research.
• Knowledge of FDA/ICH GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO environment (e.g. In-house CRA, Study Coordinator, IRB Coordinator, Regulatory Coordinator/Associate): One to three (1 - 3) years (preferred).
• Understanding of medical and clinical trials terminology.
• Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution.
• Able to work independently or with minimal supervision as well as within a team.
• Excellent attention to detail with organizational and prioritization skills for efficient productivity.
• Excellent MS Word, Excel and Outlook skills required.
• Excellent professional writing and verbal communication skills (position requires clear phone and email communication).
• Able to multi-task during the review/processing and preparation of essential regulatory documentation.
• Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
• Must have excellent time management skills, able to adhere to strict timelines and expectations.
• Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Beacon Hill Pharma
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
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