Clinical Operations Associate

Location: Rockville, Maryland / Remote work arrangement may be considered

The Clinical Research Associate (CRA) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.

The Clinical Research Associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The Clinical Research Associate will manage multiple aspects of subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

You will monitor and be responsible for the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

KEY DUTIES AND RESPONSIBILITIES:

• Developing clinical study protocols, Phase 1 to Phase 3
• Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
• Creating and writing trial protocols
• Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.
• Planning day-to-day activities for study monitoring and setting priorities by site.
• Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
• Liaise with ethics committee regarding rights, safety and well-being of trial subjects.
• Experience working with CROs and other third-party vendors during the course of clinical trial planning and execution
• Ordering, tracking and managing IP and trial materials.
• Overseeing and documenting IP dispensing, inventory and reconciliation.
• Gauging the quality of clinical deliverables and addressing quality issues with team members.
• Managing query resolution with study sites and data management operations.
• Maintaining the project tracking system of subjects and site information.
• Participating in Investigators’ Meetings as assigned by Project Managers.
• Maintaining contact with investigator sites via telephone calls between visits.
• Ensuring adherence to study timelines and budgets.
• Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
• Ensuring compliance with SOPs and local regulations, ICH and GCP guidelines.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s Degree or above required in a life science or healthcare discipline.
• 5-10 years of experience in clinical operation.
• Three (3) or more years of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Oncology or autoimmune disease experience
• For director level:  should have operations experience managing vendors and teams. This person must have extensive experience managing CROs and external and internal partners to drive projects to completion.
• Develop/write the protocol independently, write safety summaries, involved in clinical trial design and know how to monitor trials.
• Experience building teams and advise the organization on what is needed as they grow the Clinical Development team.
• Monitoring in rare and complex therapeutic areas, monitoring EDC trials and EHR records Oncology and Autoimmune disease experience or knowledge preferred.
• Relevant site start-up (feasibility, contract negotiations, submissions)
• Monitoring study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Resolving project related problems and prioritize workload to meet deadlines with oversight from management.