Clinical Trial Site Study Coordinator

2 weeks ago

Cape Town, Western Cape, South Africa TASK Full time

Clinical Trial Site Study Coordinator

Overall Purpose of the Position:


A clinical study coordinator plays a pivotal role in the execution and management of clinical trials conducted at the research site.

The position needs to acquire in-depth knowledge of relevant study protocols and will be responsible for coordinating various aspects of the clinical trial process to ensure compliance with regulatory standards, protocol requirements, and quality standards across the major aspects of clinical research including study management, data collection, participant care, participant advocacy and recruitment.

This role demands meticulous attention to detail, excellent organisational skills, and effective communication abilities to facilitate seamless collaboration among research team members, sponsors, and participants.

Specific duties and requirements may vary depending on the study protocol and site structure.

Key Performance Areas (KPAs) & Responsibilities include, but not limited to:

Protocol Adherence

  • Ensuring strict adherence to study protocols, regulatory guidelines, and standard operating procedures (SOPs) whilst ensuring participant safety throughout the conduct of the clinical trial.

Participant Recruitment and Screening

  • Collaborating with the recruitment team to identify and screen potential participants according to study eligibility criteria.
  • Maintaining accurate participant records and ensuring informed consent procedures are followed.

Study Documentation

  • Performing the preparation, maintenance, quality checks and completion of study documentation, including source and case report forms (CRFs), and study logs.
  • Maintaining accurate study documentation according to good clinical practice (GCP) and ensuring compliance with regulatory requirements and ethical guidelines.
  • Preparing, coordinating, and facilitating audits and inspections.

Clinical Trial Conduct

  • Assisting the investigators in all aspects of study management and according to delegation and training.
  • Coordinating and performing clinical trial activities, including scheduling study preparation, setup and readiness, participant visits, performing study procedures according to scope, relevant compliancy checks, quality and timely data collection and entry.
  • Monitoring participant safety and reporting adverse events according to protocol and regulatory requirements.
  • Educating participants on study related requirements and compliance.

Communication and Collaboration

  • Serving as the primary point of study contact for communication between sponsor, sponsor representative and other internal and external stakeholders.
  • Attending to and facilitating meetings to review progress, address challenges, and implement corrective actions as needed.

Quality Assurance

  • Working with the quality teams to implement quality control measures to ensure data integrity, protocol compliance, and participant safety throughout the study.
  • Conducting regular quality checks and addressing deviations or discrepancies promptly.
  • Addressing and responding to queries from sponsor representatives in an effective and timely manner.

Training and Development

  • Acquiring and completing protocol specific training and assisting investigators by coordinating training to the rest of the study team.
  • Staying up to date on relevant guidelines, regulations, and industry trends through continuous education and training.

General

  • Assisting with and performs all duties within reasonable scope.

Ideal Requirements

  • Tertiary Diploma or bachelor's degree in a related health science field, (chemistry, biology, or nursing, etc.).
  • Previous experience in clinical trials, preferably in a coordinator or similar role.
  • Strong understanding of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.
  • Professional use of the English language: both written and verbal
  • Strong administrative skills


 Computer literacy
  • Ability to use Word, PowerPoint and Excel at intermediate level.

Key Personal Inherent Characteristics

  • Excellent organisational skills with the ability to prioritise tasks and manage multiple responsibilities simultaneously.
  • Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
  • Attention to detail and a commitment to maintaining high standards of quality and compliance.
  • Functions well independently as well as in a team
  • Initiative
  • Selfdriven

Area:
Bellville, Brooklyn, Delft

Contract Type: 12 Months Fixed-Term

Applications Close:26 March 2024


TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.

Meeting our employment equity goals will be acknowledged during the recruitment process.

Job Types:
Full-time, Temporary

Contract length: 12 months

Application Deadline: 2024/03/26

  • Senior Clinical Trial Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa IAVI Full time

    Position DescriptionJob Title:Senior Clinical Trial ManagerLocation: Cape Town, South Africa; or South Africa-RemoteReports to: Associate Director, Clinical OperationsPosition Summary:Help IAVI translate science into global health impact as a Senior Clinical Trial ManagerIAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who will manage,...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa IAVI Full time

    Position DescriptionJob Title:Senior Clinical Trial ManagerLocation: Nairobi, Kenya; Cape Town, South Africa; or South Africa-RemoteReports to: Director, Clinical OperationsPosition Summary:Help IAVI translate science into global health impact as a Senior Clinical Trial ManagerIAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who...

  • Clinical Trial Administrator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:Dealing primarily with study and site administration, the Clinical Trial Administrator will provide administrative support to the site and/or study team, be responsible for basic data capture, prepare and maintain source files and investigator site files according to policy, standard operating procedures and regulatory...

  • Clinical Study Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Clinical Study Recruiter (Nurse)About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall...

  • Clinical Trials Unit Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa Desmond Tutu HIV Foundation Full time

    Overview:ReferenceDTHF/C025Salarynot applicableJob Location: South Africa City of Cape TownJob TypePermanentPostedFriday, April 12, 2024Closing date26 Apr :59CLINICAL TRIALS UNIT MANAGERPERMANENTJ52, GROOTE SCHUUR, OBSERVATORY (ON-SITE)The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in...

  • Clinical Trial Quality Assurance Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies. You...

  • Clinical Trial Quality Assurance Officer

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:As a Clinical...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa SubjectWell, Inc Full time

    About SubjectWellSubjectWell is a venture-backed technology startup on an unstoppable mission to disrupt patient recruitment for clinical trials (a $100 billion dollar sector) and connect market-ready treatments to the patients who need them. Clinical trials need millions of qualified patient volunteers but regularly fall behind schedule because patients are...

  • Clinical Trial Programme Specialist

    2 weeks ago

    Cape Town, Western Cape, South Africa SubjectWell, Inc Full time

    About SubjectWellSubjectWell is a private equity-owned company on an unstoppable mission to disrupt the antiquated $100 billion dollar clinical trial patient recruitment sector. Almost all clinical trials fall behind schedule, leaving patients unable to access the most promising treatments and pharmaceutical and biotech companies unable to quickly carry...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:The position,...

  • Clinical Trial Recruiter

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:The position,...

  • Clinical Trial Administrator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The Clinical Trial Administrator (CTA) is responsible for assisting the site and/or study team with daily clinical administrative tasks ensuring the optimal and smooth running of the day-to-day activities on site. This key administrative position is responsible for supporting the site and study team in various daily tasks,...

  • Study Nurse Coordinator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The purpose of this role is to perform procedures following the visit schedule as stipulated in each protocol and monitor the health and safety of the participants, and document the response to an intervention, which is typically new drug or therapy in the source documents. The Study Nurse Coordinator (SNC) will be responsible...

  • Study Co

    2 weeks ago

    Cape Town, Western Cape, South Africa Desmond Tutu HIV Foundation Full time

    Overview:ReferenceDTHF-069SalaryNot ApplicableJob Location: South Africa City of Cape Town MetroJob TypeContractPostedWednesday, July 26, 2023Closing date10 Aug :59STUDY CO-ORDINATORTWO (2) YEAR FIXED-TERM CONTRACTGROOTE SCHUUR HOSPITAL, OBSERVATORY (ON-SITE)The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the...

  • Lead Study Nurse Coordinator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.Overall Purpose of the Position:The purpose of...

  • Clinical Trial Administrator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The Clinical Trial Administrator will be responsible for the receiving, processing, storing, shipment of all specimens and assisting with daily administrative tasks.Key Performance Areas (KPAs) & Responsibilities include, but not limited to:Receiving of lab / specimen kits, checking of expiry dates and completeness of kits as...

  • Study Nurse Coordinator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The purpose of this role is to perform procedures following the visit schedule as stipulated in each protocol and monitor the health and safety of the participants, and document the response to an intervention, which is typically new drug or therapy in the source documents. The Study Nurse Coordinator will be responsible for...

  • Study Nurse Coordinator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The purpose of this role is to perform procedures following the visit schedule as stipulated in each protocol and monitor the health and safety of the participants, and document the response to an intervention, which is typically new drug or therapy in the source documents. The Study Nurse Coordinator (SNC) will be responsible...

  • Clinical Trial Administrator

    2 weeks ago

    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:The Clinical Trial Administrator (Paradigm) works at the research site performing daily laboratory safety and microbiology data entry, assist with receiving, processing, storing, shipment of all specimens and administrative tasks ensuring the optimal and smooth running of the day-to-day study activities. The role will be...

  • Online Data Capturing Jobs Cape Town – Clinical Trial Manager

    2 weeks ago

    Cape Town, Western Cape, South Africa Iqvia Full time

    Job Description:Clinical Trial Managers at IQVIA Biotech are responsible for the planning, implementation and execution of contracted clinical monitoring activities. They are functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.(ads1)Job Responsibilities:Coordination and oversight of daily...