Study coordinator

A Maryland-based preclinical contract research organization (CRO) providing services in the fields of drug, vaccine, and medical device development and testing.

Services offered range from early product discovery to GLP-compliant studies for regulatory submissions. The company offers integrated preclinical drug development services including cellular and animal disease model design and development, non-GLP and GLP efficacy, toxicity, biodistribution, and product release studies in a broad range of animal species.

Responsibilities :

• Compliance : Perform responsibilities under the direction of the Study Director in accordance with relevant study protocols, the Standard Operating Procedures (SOPs), and applicable regulations i.e., GLPs, USDA, etc.
• Training : Ensure personal training is documented according to Noble SOPs prior to the performance of associated procedures.
• Preclinical Study Management :
• Prepare an event schedule documenting all critical events to occur from the final study protocol and enter it into a scheduling database such as the IMS or related database.
• Ensure all necessary supplies needed to conduct the study as specified by the protocol and / or SOP are available, properly prepared and documented.
• Coordinate the preparation of labels, labeling of sample collection tubes, and other laboratory reagents.
• Coordinate the processing of various blood and tissue samples.
• Coordinate the adequate storage and inventory of samples.
• Coordinate the preparation of shipment packages for Noble’s courier, FedEx, UPS, etc.
• Collaborate :
• Collaborate with the QA to ensure study compliance and assist in audit responses.
• Collaborate with the SOP Administrator to prepare all data forms and study-specific procedures required to conduct the study as specified by the protocol and / or SOPs.
• Collaborate with the technical staff to ensure conformance of procedures and records with SOPs, the protocol and applicable regulatory requirements.
• Quality Control :
• Perform quality control reviews of study data.
• Perform duties of QC verifier of various in vivo and in vitro procedures as required.
• Collaborate in Study-Related Document Development : Assist with study-related tasks as requested by the Study Director to ensure study success, including but not limited to :
• Assist in study and IACUC protocol development.
• Assist in data entry, review, and analysis.
• Assist in final study report writing.

• Capable of working independently with minimal supervision.
• Able to handle multiple tasks, and effectively prioritize based on sales goals.
• Strong communication and interpersonal skills.
• Strong organizational skills and attention to detail required.
• Proficient in Microsoft Office 365 programs such as SharePoint, Teams, Excel, Word, and PowerPoint
• Ability to work effectively and efficiently to meet deadlines.
• Some exposure to Biologicals Sciences is recommended.

What’s in it for you :

We are a fast-growing company, with a lot of personal and professional growth opportunities. We pride ourselves on having close-knit people who are leaders in the life sciences industry.

We recognize top talents and provide pathways to prosperity for those willing to put in the work by ensuring we actively promote from within.

If you are looking to grow personally and professionally, this is a great opportunity for you. We offer :

• Competitive pay
• PTO and holiday pay
• Health, Dental, and Vision insurance
• Health savings account
• Life and disability insurance
• Matching 401K
• Tuition reimbursement program

Last updated : 2024-11-17