Clinical Trials Specialist

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The Clinical Trials Coordinator is responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits and follow-up and regulatory documentation.

Duties and responsibilities including, but not limited to:

The Clinical Trials Coordinator (CTC) is responsible for the coordination and administration of clinical trials under the direction of the Clinical Trials Director and the Medical Director. The CTC will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CTC will perform diverse administrative duties requiring analysis, sound judgement, and a high level of knowledge of study-specific protocols.

P23 Labs staff is expected to serve and protect patients by adhering to professional standards, all established policies, and procedures, and applicable federal, state, and/or accrediting requirements. Responsibilities listed below should be escalated to department and/or P23 Labs’ Chief Executive Officer.

Including, but not limited to:

• Adhere to clinical practices and protocol 
• Show vigilance in patient safety, protocol compliance and data quality
• Coordinate the conduct of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials and registries within the Clinical Research Program.
• Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens. Maintain      Delegation of Authority Logs.
• Coordinate completion and appropriate documentation of study staff training
• Collect, review and report timely, valid, accurate study data
• Be responsible for writing investigator initiated / clinical trials in collaboration with  faculty supervisor
• Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required
• Ensure quality assurance (QA) and data integrity
• Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials and registries within the Clinical Research Program
• Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study      related activities delegated to research coordinators/assistants who      provide study related support (e.g., regulatory submissions and data      entry). May be responsible for orientation/mentoring of new staff and act      as resource to current staff members with study related issues.
• Act as back-up to the laboratory managers when required
• Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts
• Monitor subjects per protocol requirements and ensure adherence to protocol
• Perform local recruiting efforts for clinical trials
• Coordinate and resolve all queries and problems associated with data submissions
• Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical      records of upcoming new and return patient clinic visits and discussing      with investigators, reaching out to potential referring physicians,      approaching potential subjects in the office or speaking to them by phone,      asking pre-screening eligibility questions, etc.)
• Provide regular updates to clients on the progress of customer service projects and campaigns that directly affect each client 
• Resolve complex client problems or disputes in a professional manner
• Keep records and documentation of client interactions for training purposes
• Innovative, creative thinking skills to help P23 remain correlated on current clinical trials that are relevant 
• Establishes market strategies by evaluating trends
• Develops organization prospects by studying economic trends and revenue opportunities, projecting acquisition and expansion prospects
• Maintain a working knowledge of general operations of P23 laboratory services 
• Communicate, engage, and interact with laboratory team and executive leadership team
• Maintain effective communication by checking and responding to P23 email correspondents and interoffice communication
• Update job knowledge by participating in educational opportunities, reading technical publications, and participating in professional societies, as applicable
• Demonstrate sound judgment and reasoning when investigating and solving problems
• Ability to comply with confidentiality of patients and employees
• Other duties as delegated

Qualifications:

• Excellent communication and interpersonal skills including written, verbal, and listening skills 
• Basic knowledge of research procedures      
• Work requires moderate speed and accuracy, excellent keyboarding skill for computer use
• Show vigilance in patient safety, protocol compliance and data quality
• Must demonstrate strong analytical thinking skills
• Superior organizational skills and time management 
• Must demonstrate ability to effectively multitask 
• Demonstrated leadership ability, confidence, and executive presence – ability to motivate staff.
• Effective problem resolution skills and solution-based thinking practices 
• Maintain a positive and professional attitude that promotes teamwork 
• Ability to work independently and execute strategic plan effectively 
• Must be able to pass background screening and random drug testing
• Able to follow instructions and protocols precisely and consistently 
• Must be able to perform work with a high degree of accuracy and attention to detail
• Work effectively in fast paced high volume environment

Working conditions:

• May be exposed to noise, dirt, dust, fumes, loud noises, and blood borne pathogens
• Potential for early morning and/or late-night responsibility, occasional 24-hour on-call duty
• Emergent situations could extend working hours or require infrequent week-end work
• Inside and sedentary, requires sitting and standing for long periods of time. Work is performed in an office environment and at outside locations. Occasional stress in dealing with multiple tasks

Physical requirements:

• Must be able to work under conditions that require sitting, standing, walking, lifting, bending, reaching, pulling, and grasping, talking, hearing, and seeing
• Lift 30 pounds
• Work with computers 
• Reasonable accommodation may be made to accommodate a qualified individual with a disability