Company Description

Cellphire Therapeutics is a Rockville, MD-based biotechnology company focused on developing platelet-based products to save lives. Our lead product, Thrombosomes®, is a platelet-based freeze-dried hemostatic. Cellphire’s goal is to revolutionize hemostasis management through the development of the next generation of platelet-based products that will efficiently stop bleeding. We believe that our products will ensure platelet availability to all patients regardless of location or environment.

Position Summary:

Clinical Research Associate is responsible for supporting or leading assigned work stream on clinical trials. Working closely with Clinical Project Manager, study coordinators, and investigators to ensure compliance with protocol and overall clinical objectives. Develops ability to organize, manage and set up priorities for multiple tasks. Supports Clinical Project Manager in management of the trial by contributing to management of vendors, data quality completion, management of sites, and any other assigned tasks. In collaboration with Clinical Project Manager, establishes strong understanding of regulations, work processes in clinical operations and the therapeutic indications studied. Maintains elevated level of professionalism within the company and at the trial sites.

Job Description

• Works with Clinical Project Manager on planning and executing clinical trial from the study startup up to trial closure activities and transfer of eTMF for archiving.
• Works collaboratively with cross-functional teams (e.g. R&D, QA, Program Management, Finance, Logistics) to compile study start up documentation and/or track various study documentations.
• As needed, this role may support site qualification, activation, management, and clinical monitoring on clinical trial.
• Assists in the process used to evaluate and select potential investigators and sites.
• May conduct oversight monitoring visits at the sites to ensure protocol compliance, accuracy and through data review by the monitors and appropriate oversight by the PI.
• Assists in CRF design and CRF guidelines.
• Develops and manages study tools and guidelines to be utilized in the study.
• Manages with logistics department and the CRO all aspects of Investigational Product shipments and accountability records
• Interacts with investigator and study coordinators through frequent communication (written and verbal)
• Maintains effective management of study issues and assigned sites.
• Presents at the Investigator/Study coordinator meetings and represents Cellphire in the meeting as applicable.
• Conducts oversight activities for the trial eTMF including review of eTMF management
• metrics and documents quality.
• Proactively identifies and works to resolve enrollment and data completion issues.
• Performs manual, in-house review of clinical trial data for completeness and accuracy.
• Reviews site’s informed consent against the master trial informed consent template for present of all GCP requirements and protocol specific information as well as for the level of written language that subject will understand.
• Develops skills in writing informed consent templates, trial plans, guidelines, forms and other documents. Applies knowledge to regulator requirement/SOPs to documents.
• Coordinates, facilitates, and documents internal meetings for the team.
• Coordinates and reviews regulatory documents from study sites
• Responsible for tracking of clinical documents as applicable
• Assist Clinical Project Manager with the investigator contract, budget and payment process including legal language and document structure as it impacts assigned trials.
• Assist Clinical Project Manager in setting up and maintaining tracker for quarterly site payments.
• Communicates status of trial to Clinical Project Manager and team as needed
• Coordinates various functional area projects and tasks as assigned
• Develops basic skills in functional area of team leadership
• Must be able to travel up to 25% of the time.

Qualifications

• BS in scientific discipline or RN license. Advanced degree (MA/MS/PharmD, PhD) preferred
• 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including at least 1-year previous experience as a monitoring CRA is plus.
• Strong working knowledge of drug development process
• Working knowledge of Good Clinical Practice and regulatory requirements.
• Able to prioritize and handle multiple tasks.
• Ability to function in a fast pace, dynamic environment and dealing with ambiguity.
• Must display problem-solving skills.
• Must be a self-starter and team player with strong interpersonal skills.
• Excellent written and verbal communication skills
• Experience working on hemostasis trials prefer but not required.
• Require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts.

Additional Information

Physical Demands: Should be able to sit at the desk or stand at a computer for prolonged periods. Also, will be required to lift boxes of files.

All your information will be kept confidential according to EEO guidelines.