Pharmaceutical Research Associates, Inc.
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
Knowledge of applicable SOPs, guidelines and study procedures.
Assist with protocol and CRF review.
Develop informed consent forms.
Conduct study feasibility and site selection activities.
Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials.
Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
Assist with investigator meeting activities including organization, preparation and attendance.
Conduct site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
Perform co-monitoring visits and performance assessment visits, when properly trained and delegated by Clinical Research Manager
Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Establish and maintain good rapport with study sites.
Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines
Coordinate timely shipment of clinical supplies and study drug to sites.
Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
Maintain adequate site tracking records.
Follow up of drug safety issues and safety reports in timely manner, if applicable.
Communicate site study issues, concerns, and progress to Clinical Research Manager, Project Manager and Clinical Team Lead accordingly.
Assist with data query form (incl. query process).
Perform telephone monitoring activities in order to obtain study status information.
Development and implementation of corrective actions when appropriate.
Prepare /review all patients tracking records.
Input and maintain study information concerning subject status of financial reimbursement to sites.
Conduct and assist with administrative activities as a member of the project team.
Mentor for Site Manager and/or Site Manager II, when assigned
Conduct on the job training and formal training to other Site Managers.
Collaborate with Clinical Research Manager/ study teams to resolve site issues
Review study visit reports, follow-up letters and site communication generated by other site managers for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead or Clinical Research Manager as needed.
Participate in routine study progress meetings, face to face or via teleconference.
Knowledge, Skills, and Abilities:
Excellent verbal and written communication skills
Excellent verbal and written English language skills
Strong computer literacy e.g. MS word, Excel, PowerPoint, internet
Excellent organizational, record retention, and time management skills
Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements.
Excellent decision making skills
Excellent customer service and interpersonal skills
Ability to manage the sites and stand alone studies independently.
Solid understanding of the drug development process with a special emphasis on clinical development.
Ability to conduct team coordination
BS degreeAtleast 4 yrs monitoring expMust have Cardiovascluar exp and if they also have Pulmonary then added bonusThey will get training on PAH (pulmonary arterial hypertension) **should either be a total of 3-4 years of Study start up SQV/SIV experience or be within the last year
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
About Pharmaceutical Research Associates, Inc.