Clinical Research Manager

Full time position: Unique and rewarding position in our Research Department as a
Research Manager/Research Coordinator of Clinical Research. Candidate must be highly motivated as self starter with a strong work ethic, time management skills, and attention to detail for the management and administrative direction of the department and study patients in a specialized Gastroenterology practice in Palm Harbor, FL.

This position is a specialized research professional working directly under the direction the Principal Investigator (PI), on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the Research Manager is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The Research Manager will work with the entire study staff team, sponsors, and monitors to ensure productivity and timely completion of studies, utilizing Good Clinical Practice, in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP):

DUTIES AND RESPONSIBILITIES - Management

• Provides leadership in clinical trial activities.
• Managed the planning, implementation, and tracking of clinical monitoring process, administration of clinical trials, and maintaining an overview of the clinical trials conducted
• Plays an active role in developing the plan and monitoring of both manpower and clinical trials so that all aspects of the plan are accurate and according to site, sponsor and regulatory guidelines.
• Accountable for site activities including site/study timelines, study visits, site selection, site initiation, site management, study drug management and close out activities
• Create strategic and organized plan to build productive and effective relationships with pharmaceutical sponsors and CRO’s.
• Communicate effectively with pharmaceutical sponsor and CRO representatives to market PDS Research.
• Complete study feasibility questionnaires based upon company history, staff and study experience, staff training, site capabilities and prior study statistics
• Maintain study projection statistics
• Communicates with vendors to implement advertising strategies through multiple sources, such as TV, radio, internet, newspaper, etc…
• Oversees the recruitment plans for ongoing studies and promotes efficient enrollment projections.
• Manage proficient and optimal operational activity of the site
• Supervises all clinical research staff
• Creates and maintains clinical research job descriptions
• Promotes effective communication in all situations
• Creates/recommends policies, procedures and processes to ensure high level of Quality Assurance and Quality Control
• Manage ongoing communications of operational issues and provides accurate progress reports on assigned activities to Investigator
• Responsible for managing site and/or vendor budget activities
• Contributes to projects that support wider organizational goals
• Creates and assists with the development of study specific forms, monitoring plans, tracking forms and other study related documents
• Ensures site is in compliance with applicable regulatory standards related to clinical trials and interactions with physicians
• Anticipates/identifies potential problems and implements corrective action plans as necessary
• Ensures compliance and overall strategic goals are accomplished
• Provides direction and knowledge as it relates to recruitment strategies
• Prepares, maintains and reviews progress reports and assigned projects
• Facilitates and participates in study specific training
• Maintains staff productivity to budgeted standards
• Create and oversee site budget and invoicing of clinical trials
• Recruits and supervises the orientation and training of clinical research personnel
• Creates, updates and trains staff on company standard operating procedures
• Creates, conducts and maintains training curriculum and documentation for all staff training to include GCP, SOP, HIPAA, OSHA, etc….
• Ensure compliance in regulatory requirements for clinical trials
• Maintain all staff curriculum vitae’s and licensure
• Track IRB approvals and renewals for clinical trials
• Processes confidentiality agreements, and clinical trial agreements to Sponsor/CRO
• Collects, reviews, files, maintains and tracks regulatory documents
• Meet with Site monitors and assist with site monitoring visits as necessary
• Complete all the documents needed in preparation for submission to the pharmaceutical sponsor and/or CRO. Such documents include, but not limited to FDA1572, Financial Disclosures, Protocol Signature Page and other regulatory required documentation for study start up.
• Evaluates, counsels and promotes the growth and development of the clinical research staff
• Coordinates and maintains the site’s long and short term goals
• Oversees the quality assurance of ongoing research
• Performs In-house audits (monitoring) of clinical research studies for compliance to ICH/GCP guidelines
• Schedules all sponsor visits to the site
• Oversees visit schedule to assist in ensuring provider coverage for study visits
• Prepares site for any sponsor and regulatory audits/inspections
• Identifies and addresses performance improvement processes
• Participates and conducts employee performance evaluations
• Medical and technical aptitude and demonstrates comprehensive and current knowledge in relevant therapeutic area
• Knowledge of Good Clinical Practice Guidelines
• Knowledge of FDA, ICH, and other regulatory regulations
• Excellent oral and written communication skills
• Demonstrates supervisory and project management skills
• Strong problem-solving abilities
• Understands HIPAA guidelines for handling subject confidentiality
• Ability to interact effectively with management and staff
• Oversees the management, hiring, yearly reviews of study coordinators
• Strong interpersonal skills
• Detail Oriented
• Excellent organizational skills
• Effective communication skills
• Strong management skills
• Self Starter

Additional :

• Ensure integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
• Discuss study protocols/informed consent process with patients and verify the informed consent documentation
• Provide patient with written communication of their participation (i.e. copy of the signed informed consent)
• Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study
• Dispense study medication in a professional and accountable manner following protocol requirements
• Collect, process, and ship blood/urine specimens at scheduled patient visits
• Perform ECGs and obtain vital signs of patients
• Schedule all patient research visits and procedures consistent with protocol requirements
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Requirements

• High School Diploma or above
• At least 3-years experience in a Research Management role with research/clinical trial experience
• ICH Good Clinical Practice (GCP) certification
• Skilled Phlebotomist
• Knowledge of Electronic Medical Records (eClinical)
• Knowledgeable of Microsoft Word
• Knowledgeable of Microsoft Excel (create and manage financial spreadsheet/tracking of payments)
• At least 5 years experience in a medical office
• Ability to multi-task and work independently

Preferred Qualifications

• Gastroenterology office experience a plus
• CCRC Certification/Degree a plus
• IATA certification a plus

Salary based on experience

ONLY QUALIFIED APPLICANTS WILL BE CONSIDERED

Job Type: Full-time

Benefits:

• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person