Clinical Research Coordinator II
This job has been closed.
Synexus offers a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!
Synexus is an Affirmative Action and Equal Opportunity Employer.
We are seeking a Clinical Research Coordinator II to join our site in Rockville, MD!
- Utilizes universal precautions, obtains and maintains certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them;
- Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
- Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;
- Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;
- Serve as Study Coordinator for a number of clinical trials;
- Manage onsite research protocol activities and assist staff in organization to ensure study protocol procedures and good clinical practices;
- Manage and participate in study recruitment to ensure enrollment goals are met or exceeded and generate reports for supervisor on patient enrollment and tracking;
- Direct and guide Research Assistant on study specific tasks;
- Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up, schedules patients, obtains informed consent, administer study medications;
- Perform appropriate research protocol procedures which may include, but are not limited to: vital signs, pregnancy tests, blood collection and processing, ECGs, alcohol breath tests and administers pain assessments;
- Ensure study related reports and patient results are reviewed by an investigator in a timely manner;
- Responsible for completion of case report forms, ensuring accuracy of data and reporting of adverse events to sponsor;
- Dispense investigational product and instruct subjects on usage and potential drug interactions;
- Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.;
- Prepare presentations to schedule training for physicians, nurses and staff on research protocol;
- Provide patient education regarding disease process and involve patient and family in decision-making processes;
- Maintain accountability of own ongoing professional growth and development;
- Performs necessary functions as approved by the Investigator and the Company after the completion of required training, for the conduct of clinical research;
- Maintain strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines;
- Responsible for drug accountability, maintaining logs and inventory of study product and supplies;
- Coordinate and conduct pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative, including completion of minutes and follow-up reports;
- Maintain contact and interact with monitors and sponsors;
- Work under direction of principal investigator;
- Attend investigator meetings; and
- May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
- A Bachelor’s degree and a minimum of 2 years of experience as a Clinical Research Coordinator, or an equivalent combination of education and experience, is required.
- Certification as a Clinical Research Coordinator is preferred.
- Proficiency with Phlebotomy and EKGs;
- Expertise with GCP and FDA/ICH regulations;
- Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;
- Exceptional organizational skills, attention to detail and follow through;
- Ability to type proficiently (35+ wpm);
- Excellent verbal and written communication skills;
- Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
- Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
- Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;
- Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.
About The Company
Join Synexus as we expand and become an important part of a well-respected and growing company that believes the details of your career are every bit as critical as the work you do!
Synexus is the world’s largest site network, with more than 195 sites and 1,500 employees globally. We provide customers with access to more than 100 million patients in key clinical development markets including Europe and the United States. Synexus is the leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. We have completed over 2,500 clinical trials in our 20+ years and operate from over 80 site network locations across the US!