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Senior CRA - Contract in HAITI

This is for a contract CRA(Clinical Research Associate) based in Haiti.
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.
Monitors investigator sites to ensure the accuracy and validity of CRF entries in 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 confirm 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 required. 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 necessary. 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 essential 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 2 years as a clinical research monitor) or equivalent combination of education, training, & experience.
Valid driver's license where applicable.
Knowledge, Skills and Abilities:
Effective clinical monitoring skills;
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of GCPs and applicable SOPs
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
PPD is an affirmative actionemployer that values diversity as a strength and fosters an environment ofmutual respect. PPD provides equal employment opportunities withoutregard to age, race, color, pregnancy, national origin, religion, sex, gender identity,sexual orientation, disability, veteran status or other status within any otherprotected group.


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