Job Description

　　CRA (level II) - Ghana (home based)

　　PPD, Part of Thermo Fisher Scientific are currently hiring for a CRA (Level II) to join our team in Ghana. This role will be home based in Ghana and involve travel to clinical trial sites.

　　At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

　　Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

　　Discover Impactful Work:

　　Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

　　A day in the Life:

　　Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.

　　Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.

　　Assess investigational products 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 and follow all issues through to resolution.

　　May need to maintain 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. Participates in the investigator payment process.

　　Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.

　　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.

　　Performs trial close out and retrieval of trial materials.

　　Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.

　　Conducts on-site file reviews as per project specifications.

　　Provides trial status tracking and progress update reports tothe Clinical Team Manager (CTM) as required.

　　Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).

　　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 applicable regulatory requirements/audits/inspections.

　　Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

　　Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.

　　Contributes to other project work and initiatives for process improvement, as required.

　　Job Complexity Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

　　Job Knowledge Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.

　　Supervision Received Normally receives detailed instructions on all work.

　　Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

　　Keys to Success:

　　Education

　　Bachelor's degree in life related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.Experience

　　Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

　　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.

　　Knowledge, Skills, Abilities

　　Proven clinical monitoring skills

　　Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

　　Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents

　　Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

　　Ability to manage Risk Based Monitoring concepts and processesGood 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

　　Good organizational and time management skills

　　Effective interpersonal skills

　　Attention to detail

　　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: solid knowledge of Microsoft Office and the ability to learn appropriate software

　　Good English language and grammar skills

　　Good presentation skills

　　#CRAdrive

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.