Lead Clinical Research Coordinator- Oncology - NJ in Teaneck, NJ at Apex Life Sciences

Date Posted: 5/25/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Clinical Research Coordinator to join our Global Bio-Pharma company located near Parsippany, NJ. The ideal candidate MUST have at least THREE years of Oncology experience, and has great communication and leaderships skills.

This is an initial contract role that will convert to permanent. 

For immediate consideration, please send resumes to: mbingham@apexlifesciences.com

PURPOSE: 

  • Lead the focused delivery and quality of the contracted clinical trial services within a project to achieve overall success of each project.
  • Focus is on leveraging clinical operations and therapeutic expertise using solutions to drive operational excellence particularly in respect to subject/patient recruitment and on-time high quality data collection.
  • The Clinical Lead Clinical Research Coordinator provides leadership of the project.,
  • Performs a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP).
  • Assist with daily workload planning. 

RESPONSIBILITIES: 

  • Lead clinical research support to investigators to prepare for and execute assigned research studies, including:Manage the operational aspects of projects to achieve “right subjects” and “right data” to meet our contractual requirements 
  • Develop, provide input, and maintain study related project plans, including but not limited to operations plan, recruitment and retention strategy plan, etc. to be incorporated into the integrated study management plan/project. 
  • Accountable for the clinical delivery (subject recruitment, study management, data integrity) of assigned portion of clinical studies per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. 
  • Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data; 
  • Lead or attend all relevant study meetings; 
  • Lead the completion Feasibility Decision Assessment Form for each new study opportunity and conduct meetings with PI, Sub-I and other stakeholders. 
  • Initiate, collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research; 
  • Create recruitment strategy for each active study and deliver a written plan to line manager prior to each SIV. 
  • Engage with physicians to involve in Qcare studies. 
  • Develop relationships with physicians not actively involved in research and identify opportunities for them to become investigators. 
  • Report and collect assigned monthly Quality metrics to line manager. 
  • Recruit and screen patients for clinical trials and maintain subject screening logs; 
  • Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits; 
  • Design and maintain source documentation based on protocol requirements; 
  • Schedule and execute study visits and perform study procedures; 
  • Record visit activity in Qcare clinical trial management system; 
  • Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness; 
  • Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics; 
  • Monitor subject safety and report adverse reactions to appropriate medical personnel; 
  • Correspond with research subjects and troubleshoot study-related questions or issues; 
  • Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards; 
  • Assist with study data quality checking and query resolution. 
  • Lead in-service meetings for all study stakeholders and document trainings. 
  • Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring. 
  • Record, report and interpret study findings appropriately to develop a study-specific database. 
  • Complete Investigator database requirements to obtain access to new study opportunities (cooperative group, CRO, Sponsor, Drug Dev, etc.) 
  • Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards. 
  • Provide training to new investigator site staff members on study-specific topics and requirements. Maintain adherence to investigator site staff training requirements by auditing and maintaining training records. 
  • Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies. 
  • Assist research site with coverage planning related to staffing and scheduling for research projects. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: 

  • Broad protocol knowledge; therapeutic knowledge 
  • Basic understanding of project financials 
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 
  • Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others; experience planning activities in advance and taking account of possible changing circumstances; manages time effectively 
  • Strong communication and presentation skills, including good command of English language 
  • Demonstrated proficiency in using systems and technology to achieve work objectives 
  • Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it 
  • Good customer service skills 
  • Strong software and computer skills, including MS Office applications 
  • Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving Proficient knowledge of the principles of Good Clinical Practices (GCP) 
  • In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules 
  • Skill in carrying out required clinical procedures such as intravenous catheter insertion and spirometry.
  • Excellent interpersonal skills 
  • Ability to pay close attention to detail 
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

  • Bachelor’s degree or educational equivalent and 5 years’relevant work experience in a clinical environment or medical setting, e.g., medical assistant, assistant nurse, laboratory technician; or equivalent combination of education, training and experience 
  • Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies 

PHYSICAL REQUIREMENTS:

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech 
  • Extensive use of keyboard requiring repetitive motion of fingers 
  • Regular sitting for extended periods of time 
  • May require occasional travel 
  • Frequent mobilization around the facility 
  • Occasional lifting and moving objects weighing up to 10 lbs/4.5 kg

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