Sr CRA (Level I)

Work Schedule
Other

Environmental Conditions
Office

Job Description

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects.

Generally required to travel 60-80% but more for some individuals.

Essential Functions and Other Job Information:

• Monitors investigator sites to ensure the accuracy and validity of CRF entries in Functions relation to patient records/clinic notes (source document verification).
• Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously, proposes solutions and follow all issues through to resolution.
• Maintains regular contact between monitoring visits with investigative sites to prove that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as the need arises. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
• Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Manages the crucial documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and federal regulatory requirements/audits.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years as a clinical research monitor).
Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Additional Requirement:

Based on Barranquilla or Cali.

Availability to travel/visit sites.