CLINICAL RESEARCH ASSOCIATE

Company Summary:
We are a full-service CRO, committed to accelerating access into emerging markets. We believe in a world that provides equal opportunities through innovative healthcare, product access and development.

We take our customers on a journey of strategic and executional healthcare transformation, navigating them through complex regional requirements, connecting them with local experts, participants, and regulators unlocking new opportunities within emerging markets through strategic and executional support.

Job Role
As a Clinical Research Associate, Ghana, you are responsible for proactively managing clinical trials and studies pertaining to clinical research by setting up the trials, collecting data, collating information. The criticality of the role is to conduct research to ensure these products are safe for market access.

Job Responsibilities
As a Clinical Research Associate, Ghana, performs the following activities:


Financial

Assists in achievement of gross margins with respect to clinical trials being conducted in the assigned market through the following initiatives:
Checks evidence of effective utilization of internal project resources to optimize costs;
Checks data related to projects and programs with respect to timelines and budgets.


Business Process

Checks whether project plans are in place and operational on site.
Checks actual progress of each trial in sites under jurisdiction vis a vis project schedules.
Monitors the study to check whether it has been carried out in accordance with applicable SOPs, laws and regulations:
Assists in developing study procedures, methodology and instructions for clinical trial staff as well as design data collection tools / Case Report Forms (CRFs);
Checks implementation of company standard operational procedures (SOPs), ICH / GCP guidelines and regulatory requirements.
Selects, initiates, monitors and closes out visits at the participating clinical trial centers:
Checks infrastructure and operational characteristics of clinical laboratories / hospitals and their suitability for clinical trials;
Checks adherence with certification standards and processes, database concepts and forms.
Collects study supplies, medical supplies and implements medication accountability.
Takes responsibility for data collection and analysis with respect to trial sites under jurisdiction in accordance with laid down principle of statistical data collection, editing, validation, analysis using the appropriate statistical techniques:
Sets up, organizes and maintains clinical study documentation (e.g., Main Study Files, CRFs, etc.) including preparation for internal / external audits, final reconciliation and archival;
Collects and verifies collected data to create reports and present results of findings to other medical staff;
Checks trial data on a regular basis to identify and report study risks and collaborates with relevant process owners for risk mitigation.


Customer Focus (External/Internal)

Monitors of patient safety throughout the duration of the study by:
Regularly reviews medical records and consults with physicians, nurses, and other staff members involved in the study;
Ensures safety and well-being of test subjects by liaising with ethics committees and assisting in submission of clinical trial documents for review of ethics committees;
Tracks adverse medical events, analyzes the same and reports in accordance with standard procedure.
Maximizes client satisfaction and retention by checking productivity indices and quality parameters with respect to clinical research projects under jurisdiction.
Reports data at periodic intervals with respect to the completion status clinical research projects under jurisdiction.


People Learning & Growth

Works with cross-functional teams.
Keeps self-updated through continuous learning.


Qualifications & Experience

Bachelor's degree in nursing Life Sciences Pharmacy
Qualification in clinical research professional examinations will be an added advantage
2-3 years’ experience in the related area