JOB ID: PLJB202301
POSITION TITLE: Senior Clinical Research Associate (Senior CRA)
TYPE OF CONTRACT: Permanent
DUTY STATION: Dakar, Sénégal or UK. Other locations may be considered
DEADLINE: 31 October 2023
About Pharmalys:
Pharmalys is an international Contract Research Organisation (CRO) with more than 15 years of experience in the management of human health research, including complex clinical trials. The company has gained a strong reputation for its industry knowledge, local expertise, and understanding of the challenges faced by the different stakeholders of this highly regulated sector.
Pharmalys expanded its services to Africa while establishing its regional headquarters in Dakar, Senegal 11 years ago. This expansion aimed to bring high-quality clinical research operations to Sub-Saharan Africa, addressing the need for increased representation and participation from the region in global clinical trials and contribution to better health outcomes for populations.
Why join Pharmalys
▶️ At Pharmalys we are led by our vision: A world free of unnecessary suffering due to unmet healthcare needs.
▶️ Our people unite around our mission for better health through data excellence. By joining our international, dynamic, and passionate team of outstanding professionals, you will have the opportunity to work on life-changing health research projects with global impact.
▶️ Diversity, inclusivity, and equal opportunities are the cornerstones of our recruitment and human resources strategy, which gives our employees the space to grow and reach their full potential.
About the role
As a member of the Study Team, the Senior Clinical Research Associate (SCRA) is responsible for routine trial site visits to ensure that the rights and well-being of trial subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents, that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), internal or sponsor’s Standard Operation Procedures, International Conference on Harmonisation/Good Clinical Practice Guidelines and applicable regulatory requirements.
Main responsibilities
As a SCRA, you will:
- Be responsible for all monitoring related activities for assigned projects and sites
- Conduct field site selection, initiation, periodic monitoring and closure visits locally and internationally to ensure adherence to the trial protocol, trial timelines, ICH/GCP, local and international applicable regulations and internal or sponsor’s SOPs
- Provide effective reports for all monitoring activities within agreed timelines
- Perform site management activities remotely and follow up on all trial-related issues at investigational sites, escalating, if necessary, to Clinical Project Managers
- Assist with trial or site feasibility process and site capacity building activities
- Coordinate or support clinical trial submissions to ethics committees and other bodies/boards
- Act as the primary line of communication between participating sites and Pharmalys Clinical Project Managers and ensure timely and accurate communication in accordance with communication plans
- Participate in coordination of clinical trials meetings (e.g. investigator meetings, Study Team meetings, CRA meetings)
- Be responsible for filing and quality control of essential documents for assigned sites in the trial master file
- Actively participate in training and mentoring of new team members by performing oversight accompanied visits with less experienced monitors
Qualification and key skills required
- Bachelor’s degree in life sciences or equivalent
- A minimum of 4 years independent monitoring experience
- Detailed knowledge of drug/vaccine/medical device development process, ICH/GCP Guidelines, and knowledge of regulatory requirements
- Full proficiency in English
- Exceptional interpersonal, organisational, and time management skills; highly collaborative
- Excellent communication skills both written and oral
- A second language (i.e. French, Portuguese, Spanish) is appreciated
- Proficient in MS Office suite
Package
This position offers an attractive remuneration package including a competitive salary, health insurance and other benefits as applicable.
How to apply
All applications must be submitted online.
Background verification may be conducted to verify information provided in the CV and available documentation.
The deadline for receiving applications is 31 October 2023 at 23:59 GMT
Travel and Location Requirements
- Up to 60 % travel commitment
- Preferred locations: Dakar, Senegal and UK. Other locations in Africa and Europe will be considered.